PRE-POWDERED VINYL EXAM GLOVES— 510(k) K042951

Name: FDA 510(k) clearance K042951
Creator: U.S. Food and Drug Administration
Published: 2005-03-10

Substantially Equivalent

Zibo Hengchang Plastic & Rubber Products Co., Ltd.

FDA 510(k) clearance K042951 for PRE-POWDERED VINYL EXAM GLOVES, Substantially Equivalent on 2005-03-10. Applicant: Zibo Hengchang Plastic & Rubber Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Zibo Hengchang Plastic & Rubber Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2004-10-26
Decision date: 2005-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Mirage, CA, US

Download summary PDF View on FDA.gov ↗

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K042952 — VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE2005-03-10

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