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FC2 Female Condom

by Clear Future, Inc.

PMA P080002

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P080002↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP080002 Date10 Mar 2009DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Single-use internal condom
PMA Number
FDA Product Code
MBU
Device Class
Class II
Regulation
21 CFR Part 884.5340
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FC2 Female Condom is a single-use internal condom classified as a barrier device for contraception and protection against sexually transmitted infections (STIs), including HIV/AIDS. It is designed to be inserted into the vagina to provide a physical barrier between sexual partners, reducing the risk of pregnancy and infection during intercourse.

This device is supplied as a sterile, single-use product intended for vaginal insertion by the user. It is regulated under FDA Premarket Approval (PMA) with PMA number P080002, falling under device class II (MBU product code). The condom is packaged for individual use and must be stored in a cool, dry place away from direct sunlight before use.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FC2 Female Condom primarily used for and how does it work?

    The FC2 Female Condom is a single-use internal barrier device designed to prevent pregnancy and protect against sexually transmitted infections (STIs), including HIV/AIDS. It works by creating a physical barrier inside the vagina during intercourse, reducing the risk of sperm entering the uterus and blocking potential pathogens from crossing between partners.

  • Is the FC2 Female Condom sterile and meant for one-time use? If so, how should it be stored?

    Yes, the FC2 Female Condom is supplied as a sterile, single-use product. Since it is intended for one-time use, it must be stored in a cool, dry place away from direct sunlight before opening. This ensures the device remains effective and uncontaminated until use.

  • What regulatory approval does the FC2 Female Condom have, and how does that affect its availability?

    The FC2 Female Condom holds FDA Premarket Approval (PMA) under PMA number P080002, classified as a Class II device under product code MBU. This approval confirms its safety and effectiveness for preventing pregnancy and STIs, ensuring it is legally available for purchase and use in the U.S. as intended.

  • How is the FC2 Female Condom packaged, and is it reusable?

    The FC2 Female Condom is packaged individually for single-use only, meaning each unit is intended to be used once and then discarded. This design ensures hygiene and prevents cross-contamination between uses.