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Latex Prophylactic Rubber Contraceptive

by J.K. Chemicals, Ltd. 510(k)

Active United States

510(k) K931077

Overview

The Latex Prophylactic Rubber Contraceptive is a barrier contraceptive device classified as a condom, designed to prevent pregnancy and reduce the risk of sexually transmitted infections during sexual intercourse. It functions by creating a physical barrier between partners, blocking sperm from entering the uterus and preventing pathogen transmission.

This device is supplied as a single-use, non-sterile product and is regulated under FDA 510(k) clearance (K931077) as a Class II medical device. It is intended for use in obstetrics and gynecology settings, adhering to regulatory standards outlined in 21 CFR 884.5300. No MRI safety information or reusable variants are specified in the data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931077 Date14 Sep 1994ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent