VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE— 510(k) K042028

Name: FDA 510(k) clearance K042028
Creator: U.S. Food and Drug Administration
Published: 2004-08-09

Substantially Equivalent

Zibo Borui Plastic & Rubber Products Co., Ltd.

FDA 510(k) clearance K042028 for VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE, Substantially Equivalent on 2004-08-09. Applicant: Zibo Borui Plastic & Rubber Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Zibo Borui Plastic & Rubber Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2004-07-28
Decision date: 2004-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Mirage, CA, US

Download summary PDF View on FDA.gov ↗

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