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Skyn Original Polyisoprene Lubricated Male Condom

by Ansell Healthcare Products, LLC

510(k) K160399

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Abbreviated NumberK160399 Date25 Jul 2016ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1530-2022 FDA Class II initiated 23 Jun 2022

    Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

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  • Withdrawn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
MOL
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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