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Power-Free Vinyl Patient Examination Gloves, Clear(Non-Colored)

by Tangshan Zhonghong Pulin Plastic Co., Ltd

510(k) K120968

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 NumberK120968 Date19 Sep 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0741-2017 FDA Class II initiated 12 Oct 2016

    A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.

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  • Withdrawn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
FDA applicant
Tangshan Zhonghong Pulin Plastic Co.,Ltd
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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