Decision Date2022-01-05
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Vinyl Exam Gloves is a medical device manufactured by Hebei Astro Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-01-05 under approval number K213019. 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 Vinyl Exam Gloves?
Vinyl Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-01-05. It is manufactured by Hebei Astro Medical Supply Co., Ltd.. The 510(k) number is K213019.
When was Vinyl Exam Gloves approved by the FDA?
Vinyl Exam Gloves received FDA 510(k) clearance on 2022-01-05, under approval number K213019.
What company makes Vinyl Exam Gloves?
Vinyl Exam Gloves is manufactured by Hebei Astro Medical Supply Co., Ltd..
What is the FDA product code for Vinyl Exam Gloves?
The FDA product code for Vinyl Exam Gloves is LYZ.
Other Devices by Hebei Astro Medical Supply Co., Ltd.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.