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Personal/DERBY Condoms

by Razi Corp.

510(k) K862401

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862401 Date4 Mar 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 1 Oct 2026

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

A condom is a device intended to prevent pregnancy and the transmission of sexually transmitted infections. This device is classified as a condom under FDA regulation number 884.5300.

It is supplied as a single-use, non-sterile product. The device received FDA 510(k) clearance (K862401) on March 4, 1987, and is manufactured by Razi Corp. in Manhasset, NY.

Other devices from Razi Corp.

Questions

AI-generated answers, 1 Oct 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 PERSONAL/DERBY CONDOMS device used for?

    The PERSONAL/DERBY CONDOMS device is intended to prevent pregnancy and the transmission of sexually transmitted infections, as it is classified as a condom under FDA regulation number 884.5300.

  • How is the PERSONAL/DERBY CONDOMS supplied and is it sterile or single-use?

    The device is supplied as a single-use, non-sterile product, meaning it is designed for one-time application and does not require sterilization prior to use.

  • What regulatory clearance does the PERSONAL/DERBY CONDOMS have and when was it granted?

    The PERSONAL/DERBY CONDOMS received FDA 510(k) clearance under submission K862401 on March 4, 1987, confirming it is substantially equivalent to a legally marketed predicate device.