Skip to content

Disposable Vinyl Nitrile Synthetic Gloves Powder Free

by Tangshan Hongyun Plastic Products Co., Ltd.

510(k) K211516

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

High-quality, disposable vinyl nitrile synthetic gloves powder-free are designed for medical professionals to ensure accurate patient examination results. These gloves feature a unique blend of materials and design elements that provide exceptional protection and comfort during prolonged use.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211516 Date24 Aug 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Other devices from Tangshan Hongyun Plastic Products Co., Ltd.