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FDA 510(k)

Non-Sterile Powder Free Nitrile Examination Gloves

K-Number: K223221 · 2023-01-13

ApplicantDynacare Sdn Bhd
Decision Date2023-01-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-Sterile Powder Free Nitrile Examination Gloves is a medical device manufactured by Dynacare Sdn Bhd. It received FDA 510(k) clearance on 2023-01-13 under approval number K223221. 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 Non-Sterile Powder Free Nitrile Examination Gloves?

Non-Sterile Powder Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Dynacare Sdn Bhd. The 510(k) number is K223221.

When was Non-Sterile Powder Free Nitrile Examination Gloves approved by the FDA?

Non-Sterile Powder Free Nitrile Examination Gloves received FDA 510(k) clearance on 2023-01-13, under approval number K223221.

What company makes Non-Sterile Powder Free Nitrile Examination Gloves?

Non-Sterile Powder Free Nitrile Examination Gloves is manufactured by Dynacare Sdn Bhd.

What is the FDA product code for Non-Sterile Powder Free Nitrile Examination Gloves?

The FDA product code for Non-Sterile Powder Free Nitrile Examination Gloves is LZA.

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Related Devices (Code: 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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