Skip to content

Vinyl Examination Gloves

by Taiwan an Lih Ent. Co., Ltd.

510(k) K893338

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

Vinyl Examination Gloves are a traditional, non-electric patient examination glove designed for general use in clinical settings. These gloves feature a vinyl material and a unique finger separation system for comfortable handling and easy dexterity. With their simplicity and effectiveness, Vinyl Examination Gloves are an ideal choice for various medical examinations.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK893338 Date15 Sep 1989ClearedStatusActive

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  • Withdrawn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
FDA applicant
Taiwan an Lih Ent. Co. , Ltd.
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent