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Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors

by Suretex Prophylactics (India), Ltd.

510(k) K981621

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981621 Date19 Jun 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0402-03 FDA Unclassified (pre-2012) initiated 25 Nov 2002

    The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards

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  • Withdrawn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
LTZ
FDA applicant
Suretex Prophylactics (India) , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.5310
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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