O'Star Nitrile Examination Gloves Powder Free
K-Number: K213058 · 2022-02-08
Decision Date2022-02-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
O'Star Nitrile Examination Gloves Powder Free is a medical device manufactured by Star Investment and Trade Joint Stock Company. It received FDA 510(k) clearance on 2022-02-08 under approval number K213058. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the O'Star Nitrile Examination Gloves Powder Free?
O'Star Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2022-02-08. It is manufactured by Star Investment and Trade Joint Stock Company. The 510(k) number is K213058.
When was O'Star Nitrile Examination Gloves Powder Free approved by the FDA?
O'Star Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2022-02-08, under approval number K213058.
What company makes O'Star Nitrile Examination Gloves Powder Free?
O'Star Nitrile Examination Gloves Powder Free is manufactured by Star Investment and Trade Joint Stock Company.
What is the FDA product code for O'Star Nitrile Examination Gloves Powder Free?
The FDA product code for O'Star Nitrile Examination Gloves Powder Free is LZA.
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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.