Single-use medical poly (vinyl chloride) examination glove
K-Number: K201504 · 2021-05-10
Decision Date2021-05-10
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Single-use medical poly (vinyl chloride) examination glove is a medical device manufactured by Anhui Bytech Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-05-10 under approval number K201504. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Single-use medical poly (vinyl chloride) examination glove?
Single-use medical poly (vinyl chloride) examination glove is a medical device that received FDA 510(k) clearance on 2021-05-10. It is manufactured by Anhui Bytech Medical Supplies Co., Ltd.. The 510(k) number is K201504.
When was Single-use medical poly (vinyl chloride) examination glove approved by the FDA?
Single-use medical poly (vinyl chloride) examination glove received FDA 510(k) clearance on 2021-05-10, under approval number K201504.
What company makes Single-use medical poly (vinyl chloride) examination glove?
Single-use medical poly (vinyl chloride) examination glove is manufactured by Anhui Bytech Medical Supplies Co., Ltd..
What is the FDA product code for Single-use medical poly (vinyl chloride) examination glove?
The FDA product code for Single-use medical poly (vinyl chloride) examination glove is LYZ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.