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Vinyl Examination Glove, Powder Free, Non-Colored

by Qingdao Lang Hui Import & Export Co., Ltd.

510(k) K093264

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK093264 Date28 May 2010ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0680-2012 FDA Unclassified (pre-2012) initiated 15 Nov 2011
    • Terminated Z-0679-2012 FDA Unclassified (pre-2012) initiated 15 Nov 2011
    • Terminated Z-0681-2012 FDA Unclassified (pre-2012) initiated 15 Nov 2011

    The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.

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  • Withdrawn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
LYZ
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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