SURGICAL GLOVES— 510(k) K895018

Name: FDA 510(k) clearance K895018
Creator: U.S. Food and Drug Administration
Published: 1990-02-16

Substantially Equivalent

Lon Tai Chemical Industrial Co., Ltd.

FDA 510(k) clearance K895018 for SURGICAL GLOVES, Substantially Equivalent on 1990-02-16. Applicant: Lon Tai Chemical Industrial Co., Ltd.. Device class: 1.

Clearance details

Applicant: Lon Tai Chemical Industrial Co., Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1989-08-08
Decision date: 1990-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changhua Taiwan 50606, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.