Decision Date2023-05-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Blue Nitrile Examination Gloves Powder Free is a medical device manufactured by Latrile Gloves Private Limited. It received FDA 510(k) clearance on 2023-05-28 under approval number K230601. 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 Blue Nitrile Examination Gloves Powder Free?
Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2023-05-28. It is manufactured by Latrile Gloves Private Limited. The 510(k) number is K230601.
When was Blue Nitrile Examination Gloves Powder Free approved by the FDA?
Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2023-05-28, under approval number K230601.
What company makes Blue Nitrile Examination Gloves Powder Free?
Blue Nitrile Examination Gloves Powder Free is manufactured by Latrile Gloves Private Limited.
What is the FDA product code for Blue Nitrile Examination Gloves Powder Free?
The FDA product code for Blue Nitrile Examination Gloves Powder Free is LZA.
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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.