0633_Guidance

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

Labeling for Natural Rubber Latex Condoms Classified
Under 21 CFR 884.5300 - Class II Special Controls
Guidance for Industry and FDA Staff
Document issued on December 23, 2008.
The draft of this document was issued November 14, 2005.
OMB control number: 0910-0633
Expiration date: May 31, 2021
See additional PRA statement in section VIII of this guidance.
For questions regarding this document, contact Paul F. Tilton 301-796-5484 or by email
at Paul.Tilton@fda.hhs.gov (mailto:Paul.Tilton@fda.hhs.gov).
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Ob/Gyn, Gastroenterology and Urology Devices Branch
Division of Enforcement A
Office of Compliance

Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency
consideration to the Division of Dockets Management, Food and Drug Administration,
5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively,
electronic comments may be submitted to Regulations.gov (http://www.regulations.gov).
When submitting comments, please refer to Docket No. FDA-2004-D-0375. Comments
may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to
CDRH-Guidance@fda.hhs.gov (mailto:CDRH-Guidance@fda.hhs.gov) to receive a copy
of the guidance. Please use the document number (1688) to identify the guidance you are
requesting.

Table of Contents
I. Introduction
II. Background
III. Other Labeling Requirements
IV. Scope
V. Issues Requiring Special Controls
VI. Labeling Recommendations
VII. Examples of Condom Labeling that Follow the Recommendations in the Guidance
VIII. Paperwork Reduction Act of 1995

Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Labeling for
Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

I. Introduction
The Food and Drug Administration (FDA) has developed this guidance as a special
controls guidance for male condoms made from natural rubber latex without spermicidal
lubricant (latex condoms).1 This guidance is issued in conjunction with a Federal Register
notice announcing the amendment of 21 CFR 884.5300, an existing classification for
condoms, from class II (performance standards) to class II (special controls). The
amended classification designates this guidance document as the special control for latex
condoms.
Latex condoms that are the subject of premarket notification submissions (510(k)s) filed
on or after January 9, 2009, the effective date of the final rule designating this as a special
control, are expected to comply with the requirement of special controls immediately
upon the rule taking effect. Therefore, a firm submitting a 510(k) for a latex condom on or
after the effective date of the rule must address the issues of safety and effectiveness
identified in this special controls guidance, either by following the recommendations of
this guidance or by some other means that provides equivalent assurances of safety and
effectiveness.
Latex condoms that are the subject of a 510(k) that is pending on the effective date of the
final rule but are subsequently cleared are expected to comply with the requirement of
special controls and address the issues of safety and effectiveness identified in this special
controls guidance, either by following the recommendations in this guidance or by some
other means that provides equivalent assurances of safety and effectiveness, on or before
March 10, 2009.
Latex condoms that were legally marketed prior to the effective date of the final rule are
expected to comply with the requirement of special controls and address the issues of
safety and effectiveness identified in this special controls guidance, either by following the
recommendations in this guidance or by some other means that provides equivalent
assurances of safety and effectiveness, on or before December 10, 2009.
If you want to discuss an alternative means of satisfying the requirement of special
controls for latex condoms, you may contact the FDA staff responsible for implementing
this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.

The Least Burdensome Approach
In developing this guidance, we carefully considered the relevant statutory criteria for
agency decision-making. We also considered the burden that may be incurred in your
attempt to comply with the guidance and address the issues we have identified. We
believe that we have considered the least burdensome approach to resolving the issues
presented in the guidance document. If, however, you believe that there is a less
burdensome way to address the issues, you should follow the procedures outlined in the
“A Suggested Approach to Resolving Least Burdensome Issues (https://wayback.archiveit.org/7993/20171031121127/https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073701.htm)
 (http://www.fda.gov/about-fda/website-policies/website-disclaimer)” document.
(Withdrawn Guidance)

II. Background
FDA believes that special controls, when combined with the general controls, will be
sufficient to provide a reasonable assurance of the safety and effectiveness of latex
condoms. Thus, a manufacturer who intends to market a device of this type must
(1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the Act),
including the 510(k) requirements described in 21 CFR Part 807, Subpart E, and the
Quality Systems Regulation (21 CFR Part 820); and (2) address the specific issues

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

requiring special controls associated with these devices as identified in this guidance,
either in the user labeling as recommended here or in some other way that provides
equivalent assurances of safety and effectiveness.
This special controls guidance document provides the classification and product code for
latex condoms (refer to Section IV). In addition, other sections of this guidance document
list the issues requiring special controls identified by FDA and describe labeling measures
that, if followed by manufacturers, will generally address the issues requiring special
controls associated with this device.
The labeling recommendations in this guidance document reflect an extensive review on
the part of the Agency, in consultation with the National Institutes for Health (NIH) and
the Centers for Disease Control and Prevention (CDC), of the available medical literature
on the safety and effectiveness of latex condoms intended to prevent pregnancy and
sexually transmitted infections (STIs). In addition, the Agency considered other relevant
information related to the barrier properties of latex condoms and the various routes of
transmission of STIs, as well as public comments on the draft of this guidance, issued
November 14, 2005 (70 FR 69156).

III. Other Labeling Requirements
While this guidance document provides examples of labeling recommended to meet the
requirement of special controls for latex condoms under 21 CFR 884.5300(b)(2), there
are also other specific labeling requirements for latex condoms contained in the following
two regulations:
• user labeling for latex condoms (21 CFR 801.435), and
• user labeling for devices that contain natural rubber (21 CFR 801.437).
Additionally, condom manufacturers must ensure that their devices meet the general
labeling requirements for medical devices described in 21 CFR Part 801.
Labeling requirements for latex condoms include the following:

A. Expiration date (21 CFR 801.435)
The retail and primary condom package (individual foil packet) must include an
expiration date that is no later than five years from the date of product packaging. This
expiration date must be supported by shelf life data developed by the condom
manufacturer. For details, please see 21 CFR 801.435, “User labeling for latex condoms.”
This regulation addresses the risk of condom deterioration due to product aging.

B. Caution regarding natural rubber latex and allergic reactions (21 CFR 801.437)
Latex condoms, and all other devices composed of, or containing, natural rubber latex
that contacts humans, are required to bear the following statement in bold print:
Caution: This Product Contains Natural Rubber Latex Which May Cause
Allergic Reactions.
This statement must appear on all device labels, and other labeling, and must also appear
on the principal display panel of the device packaging, the outside package, container or
wrapper, and the immediate device package, container, or wrapper. For details, please see
21 CFR 801.437, “User labeling for devices that contain natural rubber." This labeling
requirement is necessary because devices composed of, or containing, natural rubber
latex, pose a significant health risk to some individuals.

C. General labeling requirements

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

All devices, including latex condoms, are subject to the general labeling provisions
described in 21 CFR Part 801, Subpart A. Additionally, latex condoms are over-thecounter (OTC) devices, and are therefore subject to the requirements for OTC devices
described in 21 CFR Part 801, Subpart C. You should familiarize yourself with these
labeling requirements. This special controls guidance is consistent with these
requirements and, in fact, some of the labeling terminology used in this guidance is
described by these regulations.
Latex condoms must also include adequate directions for use to avoid being misbranded
(section 502(f) of the Act, 21 U.S.C. 352(f); 21 CFR 801.5). Adequate directions for use
help ensure that the condom will be used correctly. (Section VI.3., includes an example of
acceptable directions for use of latex condoms.)
FDA has included examples of labeling that incorporate the requirements of the Act and
regulations and the recommendations made in this special controls guidance document in
Section VII, below.

IV. Scope
The scope of this special controls guidance document is limited to male condoms made
from natural rubber latex without spermicidal lubricant (latex condoms). Latex condoms
are described in 21 CFR 884.5300 as follows:
A condom is a sheath which completely covers the penis with a closely fitting membrane.
The condom is used for contraceptive and for prophylactic purposes (preventing
transmission of sexually transmitted infections). The device may also be used to collect
semen to aid in the diagnosis of infertility.
Latex condoms are the subset of these condoms made of natural rubber latex and are
assigned the product code HIS. (See 21 CFR 884.5300(b)(2).)

Exclusions from the Scope of this Guidance:
This guidance has not been established as a special control for male condoms with
spermicidal lubricant (21 CFR 884.5310). Likewise, this guidance has not been
established as a special control for male condoms made of natural membrane (skin) or
synthetic materials that are classified under 21 CFR 884.5300(b)(1). Because male
condoms with spermicidal lubricant, natural membrane condoms, and synthetic condoms
differ in some respects from latex condoms without spermicidal lubricant, this special
control guidance does not address these products.

V. Issues Requiring Special Controls
FDA has identified the following issues requiring special controls associated with the use
of latex condoms, which can be mitigated by the labeling recommended in the special
controls guidance. The recommended mitigation measures (labeling) are intended to
provide information to users about the extent of protection provided by latex condoms to
help prevent pregnancy and help prevent the spread of various types of STIs. The labeling
provides important information for condom users to assist them in determining whether
latex condoms are appropriate for their needs, as well as instructions for optimal use.
Table 1 includes risks associated with sexual intercourse, i.e., unintended pregnancy and
STI transmission, that latex condoms are intended to prevent. This special controls
guidance document addresses how manufacturers can label their latex condoms to help
assure that they will be safe and effective for these intended uses, which are of significant
personal and public health concern. Labeling for latex condoms should follow the
mitigation measures suggested in Table 1. All the labeling recommendations are
discussed in more detail in Section VI.

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

A. Issues Requiring Special Controls and Recommended Mitigation Measures for
Latex Condoms
Table 1. Identified Issues and Recommended Mitigation Measures
Identified issues*

Recommended mitigation measures

1. Risk of Unintended Pregnancy

Labeling should indicate that latex condoms are intended to prevent
pregnancy. Labeling should indicate that condom use does not
eliminate the risk of pregnancy and also indicate the importance of
correct and consistent use.
Labeling should indicate that consumers should consult a health care
provider if they have questions about birth control options, particularly
because of health reasons for avoiding pregnancy.
Labeling should include information comparing the percentage of
women experiencing unintended pregnancy during one year of use of
latex condoms with rates experienced during one year of use of other
contraceptive methods available in the U.S., including drugs, devices,
and methods of permanent sterilization . The information should
address, at minimum, typical use rates.

2. Risk of Transmission of Sexually
Labeling should indicate that latex condoms are intended to prevent
Transmitted Infections (STIs)
HIV/AIDS and other STIs. Labeling should indicate that condom use
• Condoms reduce the overall risk does not eliminate the risk of STIs and also indicate the importance of
of STI transmission (including
correct and consistent use.
transmission of HIV/AIDS and
other STIs).
• Degree of protection against
different types of STIs varies.

Labeling should indicate that latex condoms reduce the risk of
transmission of STIs by providing a barrier against the source of the
infection.
Labeling should indicate that condoms are most effective against STIs
such as HIV/AIDS and gonorrhea that are spread by contact with the
head of the penis.
Labeling should indicate condoms are less effective against STIs such
as Human Papillomavirus (HPV) and herpes that can also be spread by
contact with infected skin that is not covered by the condom.
Labeling should indicate that consumers who believe they have an STI
should contact a health care provider.
Labeling should indicate that for more information on latex condoms or
STIs, consumers should contact a health care provider or public health
agency.

3. Incorrect or inconsistent use
diminishing the effectiveness of latex
condoms against the risks of
unintended pregnancy and STI
transmission.

Labeling should include adequate directions for use and precautions
about incorrect or inconsistent use.

* Additional risks of (1) product deterioration due to aging and (2) allergic reactions to
latex have been specifically addressed in labeling regulations that are discussed in Section
III of this guidance.

VI. Labeling Recommendations
This section provides guidance on the labeling of latex condoms grouped according to the
issues identified in Table 1 of Section V of this document. Generally, there are three
different levels of packaging for latex condoms:
• the retail package (includes the principal display panel)
• the primary condom package (individual foil packet)
• the package insert.

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

The recommendations in this section indicate the level(s) of packaging where the labeling
should appear and provide examples of labeling statements that adequately address the
issues identified in Table 1. Example statements appear in the guidance in italics to make
them easier to identify, but FDA is not recommending italic font be used in actual
labeling.

Labeling Recommendations for Latex Condoms
1. Unintended Pregnancy
1a. The principal display panel, the primary condom package (individual foil packet) and
the package insert should identify contraception as one of the principal intended actions
of the latex condom (along with preventing transmission of HIV/AIDS and other STIs, as
described in section VI.2a.)2 The following is an example of an acceptable statement
addressing both intended actions:
“Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.”
1b. The back of the retail package should contain a box entitled Important Information.
The first statements in this box should indicate that latex condom use does not
completely eliminate the risk of pregnancy and highlight the importance of correct and
consistent use. (These statements should also include the information described in
Section VI.2b of this guidance.) The following is an example of such statements:
“Latex condoms do not completely eliminate the risks of pregnancy and sexually
transmitted infections (STIs).
To get the most protection from a latex condom, use one correctly every time you have
sex. Please see directions for use inside the package.”
1c. The package insert should include a statement that consumers should consult a health
care provider if they have questions about birth control options, particularly because of
health reasons for avoiding pregnancy. The following is an example of such a statement:
"If you have questions about birth control options, particularly because of health
reasons for avoiding pregnancy, consult a health care provider."
The package insert should also contain contraceptive effectiveness information
comparing the percentage of women experiencing unintended pregnancy during one year
of use of latex condoms with rates experienced during one year of use of other
contraceptive options available in the U.S. including drugs, devices, and methods of
permanent sterilization . This information should at minimum include typical use rates.
This information is intended to enable contraceptive users to compare alternatives and
make appropriate choices. We recommend that you develop your contraceptive
effectiveness information from Hatcher, Trussell, et al. (Hatcher RA, Trussell J, Nelson
AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: Nineteenth Revised
Edition. New York NY: Ardent Media, 2007), or its updates.

2. Sexually Transmitted Infections (STIs)
Condoms reduce the overall risk of STI transmission (including transmission of
HIV/AIDS and other STIs):
2a. The principal display panel, the primary condom package (individual foil packet), and
the package insert should identify preventing transmission of HIV/AIDS and of other
STIs as a principal intended action of the latex condom (along with preventing pregnancy,
as described in section VI.1a).3 The following is an example of a statement addressing
both uses.
“Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

transmitted infections.”
2b. The back of the retail package should have a box entitled Important Information.
The first statements in this box should indicate that latex condom use does not
completely eliminate the risk of STIs and highlight the importance of correct and
consistent use. (These statements should also include the information described in
Section VI.1b of this guidance.) The following is an example of such statements:
“Latex condoms do not completely eliminate the risks of pregnancy and sexually
transmitted infections (STIs).
To get the most protection from a latex condom, use one correctly every time you have
sex. Please see directions for use inside the package.”

Degree of protection against different types of STIs varies:
STIs can be transmitted in various ways, including transmission to or from the head of
the penis and transmission by contact with infected skin not covered by the condom. The
degree of protection provided by latex condoms depends on whether the condom
provides a barrier against the source of the infection.
2c. To reflect this, the Important Informationbox on the back of the retail package
should contain the following information. The first statement, after the statements
addressing the information discussed in sections VI.1b and 2b should state that there are
many STIs, and address the differential effectiveness of condoms for various STIs. This
message should also refer consumers to the location in the labeling of additional
information on STI protection. Another statement should suggest that consumers who
believe they have an STI should contact a health care provider and that for more
information on latex condoms or STIs, consumers should contact a health care provider
or public health agency.
The following is an example of an acceptable set of statements addressing 1b, 2b, and 2c:
Important Information

• Latex condoms do not completely eliminate the risks of pregnancy and sexually
transmitted infections (STIs).
• To get the most protection from a latex condom, use one correctly every time you
have sex. Please see directions for use inside the package.
• There are many STIs. A latex condom can reduce the risk of STI transmission to or
from the head of the penis. However, some STIs can also be spread by other sexual
contact. For additional information on STI protection, please read the information
inside the package.
• If you believe you have an STI, contact a health care provider. For more
information on condoms or STIs, contact a health care provider or public health
agency.
2d. The package insert of latex condoms should contain a section stating that latex
condoms reduce the risk of STIs by providing a barrier against the source of infection.
The section should also explain that latex condoms are most effective against STIs, such
as HIV infection (AIDS) and gonorrhea, that are spread by contact with the head of the
penis. The section should also explain that condoms are less effective against STIs, such
as HPV and herpes, that can also be spread by contact with infected skin not covered by
the condom. The following is an example of an acceptable statement:
“Degree of STI Protection
Latex condoms reduce the risk of transmitting STIs by providing a barrier against the
source of the infection.

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

• Latex condoms are most effective against STIs such as HIV infection (AIDS) and
gonorrhea that are spread by contact with the head of the penis.
• Latex condoms are less effective against STIs such as Human Papillomavirus
(HPV) and herpes. These STIs can also be spread by contact with infected skin that
is not covered by the condom.”
2e. The package insert should also refer consumers to health care providers if they believe
they have an STI. The following is an example of an acceptable statement:
“If you believe you have an STI, contact a health care provider.”
2f. The package insert should notify the consumer that for additional information on latex
condoms and STIs a health care provider or public health agency should be contacted.
The following is an example of an acceptable statement:
“For more information on latex condoms or STIs, contact a health care provider or a
public health agency.”

3. Incorrect or Inconsistent Use
Latex condoms must include adequate directions for use to avoid being misbranded
(section 502(f) of the Act, 21 U.S.C. 352(f); 21 CFR 801.5). Adequate directions for use
will also help address the issue of incorrect or inconsistent use. Precautions should also
address this issue. We provide examples of appropriate directions for use and precautions
for latex condoms below. Manufacturers may have additional directions for use,
precautions, or other information that they believe is necessary for proper use of their
products. Such additional information is acceptable as long as it does not conflict with or
detract from the statements recommended in this guidance (or equivalent statements) or
any other applicable requirements (see Section III).

3a. Directions for Use:
The following set of statements is an example of acceptable directions for use for latex
condoms:4
Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.
1. Use a new condom for each act of sex.
2. Tear open the package carefully. Do not use fingernails, teeth, or anything that
can damage the condom.
3. Before any sexual contact, place the condom on the head of the erect penis with the
rolled side out.
◦ Lesions, pre-ejaculate secretions, semen, vaginal secretions and blood can all
transmit infectious organisms.
4. Unroll or pull the condom all the way to the base of the erect penis. If the condom
doesn’t unroll easily, it may be on backwards, damaged or too old. Throw it away
and start over with a new condom.
5. Immediately after ejaculation, hold the rim of the condom in place and withdraw
the penis while it is still erect.
◦ Avoid spilling semen.
6. Dispose of a used condom by wrapping it in tissue and throwing it into the trash.
Wash your hands with soap and water.

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

Pictorial representations of each direction for use are recommended. Line art attracts and
keeps a reader’s interest and is often remembered longer than words. Properly chosen
and placed illustrations re-emphasize the text, make it more meaningful, and reduce the
burden of details in the text. Graphics should:
• be simple and clearly drawn, without clutter, unneeded background, or extraneous
detail
• be placed next to corresponding text
• use cues such as circles or arrows to point out key information
• be clearly labeled
• be easy to understand
• be recognizable to the audience

3b. Precautions
The following set of statements is an example of acceptable precautions regarding
condom use:
• Do not reuse latex condoms.
• Store latex condoms in a cool, dry place (below 100ºF) and avoid exposure to
direct sunlight.
• If the rubber material is sticky or brittle or obviously damaged, do not use the
condom.
• If the color is uneven or changed, do not use the condom.
• Make sure there is adequate lubrication. If you add lubricant, use a water-based
lubricant. [Manufacturers may identify one or more examples.] DO NOT USE OILBASED LUBRICANTS, such as those made with petroleum jelly (e.g., Vaseline ®),
mineral oil, vegetable oil, or cold cream, as these may damage the condom.

VII. Examples of Condom Labeling that Follow the Recommendations in
the Guidance
Label statements appearing in italics are those recommended in Section VI of the current
guidance. Other label statements, discussed in Section III of this guidance, appear in
regular font. This difference in font styles is used only to identify the labeling
recommended by this guidance as a special control. FDA is not recommending italic font
for the actual label statements provided by manufacturers.
In recognition of the variety of ways that manufacturers may configure their labeling to
satisfy their statutory and regulatory labeling obligations as well as incorporate the
recommendations of this guidance, this section does not include a full mock-up of a
package insert, but gives only selected examples of recommended language. Please
consult the body of this guidance, 21 CFR Part 801, and the Act, for other information on
the full content of labeling.

Front panels of condom retail package:
Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.
Caution: This Product Contains Natural Rubber Latex Which May Cause
Allergic Reactions.
When used correctly every time you have sex, latex condoms help prevent pregnancy and reduce the risk of
transmitting HIV/AIDS, and other sexually transmitted infections.5

XYZ Brand Latex Condoms

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

# (net quantity) Latex Condom

Rear panel of condom retail package
Important Information
• Latex condoms do not completely eliminate the risks of pregnancy and sexually transmitted infections
(STIs).
• To get the most protection from a latex condom, use one correctly every time you have sex. Please see
directions for use inside the package.
• There are many STIs. A latex condom can reduce the risk of STI transmission to or from the head of the
penis. However, some STIs can also be spread by other sexual contact. For additional information on STI
protection, please read the information inside the package.
• If you believe you have an STI, contact a health care provider. For more information on condoms or STIs,
contact a health care provider or public health agency.
Distributed by XYZ Corporation
Rockville, Maryland

EXP. Date: Jan 20XX

Primary condom package (individual foil packet):
Front of packet

Back of packet

One XYZ Brand Latex Condom 

Before using, please see directions for use inside the

Latex condoms are intended to prevent pregnancy,
HIV/AIDS, and other sexually transmitted infections.
Caution: This Product Contains Natural Rubber Latex
Which May Cause Allergic Reactions.

package.
Distributed by XYZ Corporation
Rockville, Maryland
EXP Date: Jan 20XX

Examples of information to be included in package insert:
Directions for Use
Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.
1. Use a new condom for each act of sex.
2. Tear open the package carefully. Do not use fingernails, teeth, or anything that
can damage the condom.
3. Before any sexual contact, place the condom on the head of the erect penis with the
rolled side out.
◦ Lesions, pre-ejaculate secretions, semen, vaginal secretions and blood can all
transmit infectious organisms.
4. Unroll or pull the condom all the way to the base of the erect penis. If the condom
doesn’t unroll easily, it may be on backwards, damaged or too old. Throw it away
and start over with a new condom.
5. Immediately after ejaculation, hold the rim of the condom in place and withdraw
the penis while it is still erect.
◦ Avoid spilling semen.
6. Dispose of a used condom by wrapping it in tissue and throwing it into the trash.
Wash your hands with soap and water.

Package insert (cont.)
Precautions:
• Do not reuse latex condoms.

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

• Store latex condoms in a cool, dry place (below 100ºF) and avoid exposure to direct
sunlight.
• If the rubber material is sticky or brittle or obviously damaged, do not use the
condom.
• If the color is uneven or changed, do not use the condom.
• Make sure there is adequate lubrication. If you add lubricant, use a water-based
lubricant. [Manufacturers may identify one or more examples.] DO NOT USE OILBASED LUBRICANTS, such as those made with petroleum jelly (e.g., Vaseline®),
mineral oil, vegetable oil, or cold cream, as these may damage the condom.
Degree of STI Protection
Latex condoms reduce the risk of transmitting STIs by providing a barrier against the
source of the infection.
• Latex condoms are most effective against STIs such as HIV infection (AIDS) and
gonorrhea that are spread by contact with the head of the penis.
• Latex condoms are less effective against STIs such as Human Papillomavirus (HPV)
and herpes. These STIs can also be spread by contact with infected skin that is not
covered by the condom.
If you believe you have an STI, contact a health care provider. For more information on
latex condoms or STIs, contact a health care provider or a public health agency.

VIII. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 12
hours per response, including the time to review instructions, search existing data
sources, gather the data needed, and complete and review the information collection.
Send comments regarding this burden estimate or suggestions for reducing this burden
to:
FDA PRA Staff,
Office of Operations,
Food and Drug Administration,
PRAStaff@fda.hhs.gov (mailto:PRAStaff@fda.hhs.gov)
This guidance also refers to previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of information in 21
CFR part 820 have been approved under OMB control number 0910-0073; the
collections of information in 21 CFR part 801, including those in 21 CFR 801.435,
referenced in the guidance, have been approved under OMB control number 0910-0485.
The latex allergy caution required by 21 CFR 801.437 and referenced in the guidance does
not constitute a "collection of information" under the PRA. Rather, it is a "public
disclosure of information originally supplied by the Federal government to the recipient
for the purpose of disclosure to the public." (5 CFR 1320.3(c)(2)).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. The OMB control number for this information collection is
0910-0633 (expires May 31, 2021).

Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls G...

1

As discussed in section IV of this guidance, male condoms made of natural rubber latex

with spermicidal lubricant (21 CFR 884.5310), which includes lubricant that contains
nonoxynol-9 (N-9), are not within the scope of this guidance.
2

In the package insert, this statement may be included in the directions for use, to satisfy

the requirements of 21 CFR 801.5(a).
3

In the package insert, this statement may be included in the directions for use, to satisfy

the requirements of 21 CFR 801.5(a).
4

Adequate directions for use must contain a statement of indications for use. (21 CFR

801.5(a)). As indicated in the example below, the statement recommended under sections
1a and 2a may be incorporated into the instructions for use to fulfill this requirement.
5

You may add this statement to the “top shelf” of the condom retail package (the front

panels also include the hanger and main box front).