PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)— 510(k) K963514

Name: FDA 510(k) clearance K963514
Creator: U.S. Food and Drug Administration
Published: 1996-10-24

Substantially Equivalent

Shanghai PM Plastics Enterise Co., Ltd.

FDA 510(k) clearance K963514 for PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED), Substantially Equivalent on 1996-10-24. Applicant: Shanghai PM Plastics Enterise Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shanghai PM Plastics Enterise Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1996-09-03
Decision date: 1996-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Songjiang Co., Shanghai, CN

Download summary PDF View on FDA.gov ↗

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