DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE— 510(k) K001611

Name: FDA 510(k) clearance K001611
Creator: U.S. Food and Drug Administration
Published: 2000-06-30

Substantially Equivalent

Shanghai PT Plastics Enterprise Company, Ltd.

FDA 510(k) clearance K001611 for DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE, Substantially Equivalent on 2000-06-30. Applicant: Shanghai PT Plastics Enterprise Company, Ltd.. Device class: 1.

Clearance details

Applicant: Shanghai PT Plastics Enterprise Company, Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2000-05-25
Decision date: 2000-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Songjiang County Shanghai, CN

Download summary PDF View on FDA.gov ↗

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