VINYL PATIENT EXAMINATION GLOVE— 510(k) K890985

Name: FDA 510(k) clearance K890985
Creator: U.S. Food and Drug Administration
Published: 1989-03-29

Substantially Equivalent

Am Gloves Co., Ltd.

FDA 510(k) clearance K890985 for VINYL PATIENT EXAMINATION GLOVE, Substantially Equivalent on 1989-03-29. Applicant: Am Gloves Co., Ltd.. Device class: 1.

Clearance details

Applicant: Am Gloves Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1989-03-01
Decision date: 1989-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainan Hsien, Taiwan, TW

Download summary PDF View on FDA.gov ↗

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