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FDA 510(k)

Nitrile Patient Examination Glove

K-Number: K210730 · 2021-08-10

ApplicantAmerican Performance Polymers, LLC
Decision Date2021-08-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Patient Examination Glove is a medical device manufactured by American Performance Polymers, LLC. It received FDA 510(k) clearance on 2021-08-10 under approval number K210730. 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 Nitrile Patient Examination Glove?

Nitrile Patient Examination Glove is a medical device that received FDA 510(k) clearance on 2021-08-10. It is manufactured by American Performance Polymers, LLC. The 510(k) number is K210730.

When was Nitrile Patient Examination Glove approved by the FDA?

Nitrile Patient Examination Glove received FDA 510(k) clearance on 2021-08-10, under approval number K210730.

What company makes Nitrile Patient Examination Glove?

Nitrile Patient Examination Glove is manufactured by American Performance Polymers, LLC.

What is the FDA product code for Nitrile Patient Examination Glove?

The FDA product code for Nitrile Patient Examination Glove 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.

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