Decision Date2021-12-18
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
USA Gloves Nitrile Powder Free Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Usa Gloves. It received FDA 510(k) clearance on 2021-12-18 under 510(k) number K211624. 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 USA Gloves Nitrile Powder Free Exam Gloves?
USA Gloves Nitrile Powder Free Exam Gloves is a medical device that received FDA 510(k) clearance on 2021-12-18. The listed applicant is Usa Gloves. The 510(k) number is K211624.
When did USA Gloves Nitrile Powder Free Exam Gloves receive FDA 510(k) clearance?
USA Gloves Nitrile Powder Free Exam Gloves received FDA 510(k) clearance on 2021-12-18, under 510(k) number K211624.
Who is the listed applicant for USA Gloves Nitrile Powder Free Exam Gloves?
The FDA 510(k) record lists Usa Gloves as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for USA Gloves Nitrile Powder Free Exam Gloves?
The FDA product code for USA Gloves Nitrile Powder Free Exam Gloves is LZA.
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Related Devices (Code: LZA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.