Powder Free Vinyl Patient Examination Gloves— 510(k) K211177

Name: FDA 510(k) clearance K211177
Creator: U.S. Food and Drug Administration
Published: 2021-07-17

Substantially Equivalent

Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.

FDA 510(k) clearance K211177 for Powder Free Vinyl Patient Examination Gloves, Substantially Equivalent on 2021-07-17. Applicant: Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-04-20
Decision date: 2021-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shijiazhuang, CN

Download summary PDF View on FDA.gov ↗

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