FDA 510(k)

Proclean - Nitrile Powder Free Examination Gloves

Numéro K : K211374 · 2021-10-13

Date de décision2021-10-13

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Proclean - Nitrile Powder Free Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Dr.Boo Company Limited. It received FDA 510(k) clearance on 2021-10-13 under 510(k) number K211374. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Dr.Boo Company Limited. The 510(k) number is K211374.

When did Proclean - Nitrile Powder Free Examination Gloves receive FDA 510(k) clearance?

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

Who is the listed applicant for Proclean - Nitrile Powder Free Examination Gloves?

The FDA 510(k) record lists Dr.Boo Company Limited as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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