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FDA 510(k)

Powder Free Nitrile Examination Glove

K-Number: K210369 · 2021-05-13

ApplicantPastel Glove Sdn Bhd
Decision Date2021-05-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Glove is a medical device manufactured by Pastel Glove Sdn Bhd. It received FDA 510(k) clearance on 2021-05-13 under approval number K210369. 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 Powder Free Nitrile Examination Glove?

Powder Free Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2021-05-13. It is manufactured by Pastel Glove Sdn Bhd. The 510(k) number is K210369.

When was Powder Free Nitrile Examination Glove approved by the FDA?

Powder Free Nitrile Examination Glove received FDA 510(k) clearance on 2021-05-13, under approval number K210369.

What company makes Powder Free Nitrile Examination Glove?

Powder Free Nitrile Examination Glove is manufactured by Pastel Glove Sdn Bhd.

What is the FDA product code for Powder Free Nitrile Examination Glove?

The FDA product code for Powder Free Nitrile 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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