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FDA 510(k)

Proclean - Nitrile Powder Free Examination Gloves

K-Number: K211374 · 2021-10-13

ApplicantDr.Boo Company Limited
Decision Date2021-10-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Proclean - Nitrile Powder Free Examination Gloves is a medical device manufactured by Dr.Boo Company Limited. It received FDA 510(k) clearance on 2021-10-13 under approval number K211374. 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 Proclean - Nitrile Powder Free Examination Gloves?

Proclean - Nitrile Powder Free Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-10-13. It is manufactured by Dr.Boo Company Limited. The 510(k) number is K211374.

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

Proclean - Nitrile Powder Free Examination Gloves received FDA 510(k) clearance on 2021-10-13, under approval number K211374.

What company makes Proclean - Nitrile Powder Free Examination Gloves?

Proclean - Nitrile Powder Free Examination Gloves is manufactured by Dr.Boo Company Limited.

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

The FDA product code for Proclean - Nitrile Powder Free 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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