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Biogel Neotech II Powder-Free Neoprene Surgeon's Glove

by Ssl Americas, Inc. (Regent Medical)

510(k) K000421

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 NumberK000421 Date14 Aug 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0346-03 FDA Unclassified (pre-2012) initiated 25 Nov 2002

    Sulfur particles on the surface of gloves.

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  • Withdrawn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
KGO
Device Class
Class I
Regulation
21 CFR Part 878.4460
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent