TOPLAS VINYL PATIENT EXAMINATION GLOVE— 510(k) K891646

Name: FDA 510(k) clearance K891646
Creator: U.S. Food and Drug Administration
Published: 1989-04-25

Substantially Equivalent

Toplas Industrial Co., Ltd.

FDA 510(k) clearance K891646 for TOPLAS VINYL PATIENT EXAMINATION GLOVE, Substantially Equivalent on 1989-04-25. Applicant: Toplas Industrial Co., Ltd.. Device class: 1.

Clearance details

Applicant: Toplas Industrial Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1989-03-17
Decision date: 1989-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keelung, TW

Download summary PDF View on FDA.gov ↗

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