FDA 510(k)

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Numéro K : K212916 · 2022-03-24

Date de décision2022-03-24

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Black Nitrile Powder Free Patient Examination Glove, Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Rimba Glove Sdn Bhd. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K212916. 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 Black Nitrile Powder Free Patient Examination Glove, Non Sterile?

Black Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Rimba Glove Sdn Bhd. The 510(k) number is K212916.

When did Black Nitrile Powder Free Patient Examination Glove, Non Sterile receive FDA 510(k) clearance?

Black Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2022-03-24, under 510(k) number K212916.

Who is the listed applicant for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?

The FDA 510(k) record lists Rimba Glove Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?

The FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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