Single-use medical poly (vinyl chloride) examination glove— 510(k) K201504

Name: FDA 510(k) clearance K201504
Creator: U.S. Food and Drug Administration
Published: 2021-05-10

Substantially Equivalent

Anhui Bytech Medical Supplies Co., Ltd.

FDA 510(k) clearance K201504 for Single-use medical poly (vinyl chloride) examination glove, Substantially Equivalent on 2021-05-10. Applicant: Anhui Bytech Medical Supplies Co., Ltd.. Device class: 1.

Clearance details

Applicant: Anhui Bytech Medical Supplies Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2020-06-05
Decision date: 2021-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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