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Osmanthus, Kongfu, and Gobon, Natural Rubber Latex Condoms

by Guilin Latex Factory

510(k) K994118

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK994118 Date14 Aug 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0054-2008 FDA Unclassified (pre-2012) initiated 11 Sep 2007

    Condoms fail the water leak test and package integrity

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  • Withdrawn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