Nil Patient Examination Gloves

by United Lion Rubber Industries Sdn. Bhd.

510(k) K895641

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) K895641↗

FDA record

Trust

Unverified

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

Overview

Nil Patient Examination Gloves are a high-quality, FDA-cleared medical device designed for the examination of patients in a clinical setting. These gloves provide a sterile and comfortable interface for healthcare professionals to collect vital signs and perform examinations, reducing the risk of infection and improving patient care.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK895641	Date4 Oct 1989Cleared	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Withdrawn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: K895641
FDA Product Code: LYY

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

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