Internal Condom: What It Is and How FDA Classifies It

General product and regulatory information only; this page is not medical advice. Questions about contraception or infection prevention belong with a clinician.

Short answer

An internal condom is a sheath-like device that lines the vaginal or anal wall and is intended for single use. In the United States, FDA classifies the single-use version as a Class II device under 21 CFR 884.5340 (product code MBU), indicated for contraception and/or prevention of sexually transmitted infections. “Female condom” is the older name for the same kind of product.

What is an internal condom?

The regulation defines a “single-use internal condom” as an over-the-counter sheath-like device that lines the vaginal or anal wall and is discarded after use. It is indicated for contraception and/or for prophylactic purposes, meaning preventing transmission of sexually transmitted infections (21 CFR 884.5340(a), checked 2026-10-30).

Two points about scope follow from that wording. First, the regulation names the vaginal or anal wall, so “internal” is the broader term and “female condom” is the older label. Second, “over-the-counter” is part of the identification: it is a consumer device, not a prescription item.

How it is regulated and what makers must show

Under 21 CFR 884.5340(b), the single-use internal condom is Class II with special controls. The special controls are the most useful part of the regulation for anyone who reads product labeling or supplier documentation. In summary, they require:

• Clinical performance testing: the rate of clinical failure and of individual failure modes from an acute failure-modes study of the intended use (vaginal and/or anal intercourse), plus a cumulative pregnancy rate from a contraceptive effectiveness study when the device is indicated for vaginal intercourse.
• Viral penetration testing: demonstration that the device is an effective barrier to sexually transmitted infections.
• Nonclinical performance testing: tensile, tear and burst properties, and compatibility testing with personal lubricants to determine whether lubricants adversely affect the device’s physical properties.
• Biocompatibility and shelf-life testing, including package integrity for the full shelf life.
• Labeling: a contraceptive effectiveness table comparing typical-use and perfect-use pregnancy rates with other birth control methods; a statement of associated adverse events (potential transmission of infection, adverse tissue reaction, and ulceration or other physical trauma); an expiration date; and a statement on compatibility with additional types of personal lubricants.

The special controls were published at 83 FR 48714 (27 September 2018).

Types and related classifications

FDA’s classification database separates internal condoms from external condoms and from an older multiple-use female condom category. The rows below come from the openFDA device classification records and the CFR sections cited under Sources (checked 2026-10-30).

Device (FDA name)	Product code	Class	Regulation	Use per regulation
Single-use internal condom	MBU	II	21 CFR 884.5340	Single use; discarded after use
Condom, female, animal tissue (multiple-use female condom)	OBY	III	21 CFR 884.5330	Lines the vaginal wall; “can be reused” after coitus
Condom (external)	HIS	II	21 CFR 884.5300	Classified separately from internal condoms
Condom, synthetic (external)	MOL	II	21 CFR 884.5300	Classified separately from internal condoms

Female condom types

In the FDA scheme the practical distinction is single-use versus multiple-use. The multiple-use female condom regulation (884.5330) describes a sheath-like device lining the vaginal wall that can be reused, and places it in Class III, which requires premarket approval. The single-use internal condom (884.5340) is the Class II category.

Regulatory record trail

openFDA’s premarket approval (PMA) records show how this category reached the market. Earlier products were approved as PMAs under product code MBU: P910064 (Reality Female Condom, Female Health Co., supplements 1995 to 1997) and P940033 (Femidom, decision 14 April 1995). The FC2 Female Condom, P080002 from Clear Future, Inc., has an original decision date of 10 March 2009, generic name “Single-use internal condom”; supplement S001 (23 September 2011) concerned shelf life, changing it from 3 to 4 years, and S002 followed on 23 June 2017 (openFDA PMA API, checked 2026-10-30). A search of openFDA 510(k) records for product code MBU returned no records on the same date, so this category should not be described as a 510(k) market.

Where it matters for labs, clinics and supply decisions

For staff who handle or document these products, the special controls double as a checklist of what appropriate labeling should contain. A package insert or supplier sheet can be compared against it:

• Is there a contraceptive effectiveness table with typical-use and perfect-use rates?
• Is there an adverse-event statement covering infection transmission, tissue reaction and ulceration or physical trauma?
• Is an expiration date printed?
• Is there a statement on compatibility with other personal lubricants?

Lubricant compatibility is also visible from the other side. FDA’s product-code definition for personal lubricants (QPD) says its compatibility labeling may refer to natural rubber latex, polyisoprene, polyurethane and/or “internal condoms”. See also CASRAI’s guides on fertility-friendly lubricant and polyisoprene, and on spermicidal condoms.

Common misunderstandings

• “Internal condom” and “female condom” are interchangeable. Not in FDA’s scheme: the current single-use category is named “internal condom” and covers vaginal or anal use, while the separate “female condom” regulation covers a multiple-use device.
• It shares a product code with external condoms. It does not. Internal condoms are MBU under 884.5340; external condoms are HIS and MOL under 884.5300.
• All female condoms are Class II. Only the single-use internal condom is. The multiple-use female condom category is Class III.
• It cleared through the 510(k) route. The FDA records above show PMA approvals for this product code.

FAQ

What is an internal condom?

A sheath-like, over-the-counter device that lines the vaginal or anal wall, intended for single use, indicated for contraception and/or preventing sexually transmitted infections (21 CFR 884.5340(a)).

Is an internal condom the same as a female condom?

“Female condom” is the older term. FDA now classifies the single-use product as an “internal condom”; a separate multiple-use female condom category (21 CFR 884.5330, Class III) also exists.

How does FDA classify internal condoms?

Single-use internal condoms are Class II with special controls (product code MBU, 21 CFR 884.5340).

What must the labeling include?

A contraceptive effectiveness table, an adverse-event statement, an expiration date, and a statement on compatibility with additional personal lubricants.

Sources

• 21 CFR 884.5340, Single-use internal condom, via Cornell LII: law.cornell.edu/cfr/text/21/884.5340 (checked 2026-10-30).
• 21 CFR 884.5330, Female condom, via Cornell LII: law.cornell.edu/cfr/text/21/884.5330 (checked 2026-10-30).
• openFDA device classification API, product codes MBU, OBY, HIS, MOL and QPD: api.fda.gov/device/classification.json (checked 2026-10-30).
• openFDA PMA API, record P080002 and related PMAs: api.fda.gov/device/pma.json (checked 2026-10-30).