POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)— 510(k) K082691

Name: FDA 510(k) clearance K082691
Creator: U.S. Food and Drug Administration
Published: 2009-02-04

Substantially Equivalent

Hebei Handform Plastic Products Co., Ltd.

FDA 510(k) clearance K082691 for POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED), Substantially Equivalent on 2009-02-04. Applicant: Hebei Handform Plastic Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hebei Handform Plastic Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2008-09-15
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhong Road; Beijing, CN

Download summary PDF View on FDA.gov ↗

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