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FDA 510(k)

Non-sterile Powder Free Nitrile Examination Gloves

K-Number: K210990 · 2021-11-22

ApplicantRubberex Alliance Sdn Bhd
Decision Date2021-11-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-sterile Powder Free Nitrile Examination Gloves is a medical device manufactured by Rubberex Alliance Sdn Bhd. It received FDA 510(k) clearance on 2021-11-22 under approval number K210990. 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 2021-11-22. It is manufactured by Rubberex Alliance Sdn Bhd. The 510(k) number is K210990.

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 2021-11-22, under approval number K210990.

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

Non-sterile Powder Free Nitrile Examination Gloves is manufactured by Rubberex Alliance 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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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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