POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE— 510(k) K111598

Name: FDA 510(k) clearance K111598
Creator: U.S. Food and Drug Administration
Published: 2011-07-20

Substantially Equivalent

Lpl (Hui Zhou) Glove Co., Ltd.

FDA 510(k) clearance K111598 for POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE, Substantially Equivalent on 2011-07-20. Applicant: Lpl (Hui Zhou) Glove Co., Ltd.. Device class: 1.

Clearance details

Applicant: Lpl (Hui Zhou) Glove Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2011-06-08
Decision date: 2011-07-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hampton, VA, US

Download summary PDF View on FDA.gov ↗

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