Skip to content

Power-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color

by Shen Wei (Usa), Inc. 510(k)

Active United States

510(k) K121528

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121528 Date11 Sep 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LZA
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Shen Wei (Usa), Inc.

See all devices from Shen Wei (Usa), Inc. →