PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES— 510(k) K983613

Name: FDA 510(k) clearance K983613
Creator: U.S. Food and Drug Administration
Published: 1999-10-27

Substantially Equivalent

Shanghai Jiatai Plastic Products Co., Ltd.

FDA 510(k) clearance K983613 for PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES, Substantially Equivalent on 1999-10-27. Applicant: Shanghai Jiatai Plastic Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shanghai Jiatai Plastic Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1998-10-14
Decision date: 1999-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, NV, US

Download summary PDF View on FDA.gov ↗

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