Patient Examination Gloves

by Pro-Tex Products, Inc.

510(k) K894121

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

510(k) K894121↗

FDA record

Trust

Unverified

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

Overview

Patient examination gloves are a crucial component in healthcare, offering enhanced safety and comfort for patients. These gloves feature advanced materials, ergonomic design, and built-in protection against bloodborne pathogens.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK894121	Date2 Jan 1990Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K894121
FDA Product Code: LYY

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