LATEX SURGICAL GLOVE— 510(k) K881664

Name: FDA 510(k) clearance K881664
Creator: U.S. Food and Drug Administration
Published: 1989-01-06

Substantially Equivalent

Lien Chang Rubber Industrial Co., Ltd.

FDA 510(k) clearance K881664 for LATEX SURGICAL GLOVE, Substantially Equivalent on 1989-01-06. Applicant: Lien Chang Rubber Industrial Co., Ltd.. Device class: 1.

Clearance details

Applicant: Lien Chang Rubber Industrial Co., Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1988-04-18
Decision date: 1989-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chang Hua Hsien, Taiwan, TW

Download summary PDF View on FDA.gov ↗

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