FDA 510(k)

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves

K-Number: K220118 · 2022-05-12

ApplicantKl-Kepong Rubber Products Sdn. Bhd.

Decision Date2022-05-12

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves is a medical device manufactured by Kl-Kepong Rubber Products Sdn. Bhd.. It received FDA 510(k) clearance on 2022-05-12 under approval number K220118. 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 Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves?

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-05-12. It is manufactured by Kl-Kepong Rubber Products Sdn. Bhd.. The 510(k) number is K220118.

When was Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves approved by the FDA?

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves received FDA 510(k) clearance on 2022-05-12, under approval number K220118.

What company makes Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves?

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves is manufactured by Kl-Kepong Rubber Products Sdn. Bhd..

What is the FDA product code for Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves?

The FDA product code for Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves is LZA.

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Other Devices by Kl-Kepong Rubber Products Sdn. Bhd.

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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.