POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE— 510(k) K100978

Name: FDA 510(k) clearance K100978
Creator: U.S. Food and Drug Administration
Published: 2010-08-12

Substantially Equivalent

Jiangsu Sunshine Plastic Products, Co., Ltd.

FDA 510(k) clearance K100978 for POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE, Substantially Equivalent on 2010-08-12. Applicant: Jiangsu Sunshine Plastic Products, Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jiangsu Sunshine Plastic Products, Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2010-04-08
Decision date: 2010-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei County, TW

Download summary PDF View on FDA.gov ↗

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