FDA 510(k)

White Nitrile Powder Free Patient Examination Glove, Non Sterile

Numéro K : K210775 · 2021-06-28

Date de décision2021-06-28

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

White Nitrile Powder Free Patient Examination Glove, Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Onetexx Sdn Bhd. It received FDA 510(k) clearance on 2021-06-28 under 510(k) number K210775. 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 White Nitrile Powder Free Patient Examination Glove, Non Sterile?

White Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is Onetexx Sdn Bhd. The 510(k) number is K210775.

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

White Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2021-06-28, under 510(k) number K210775.

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

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

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

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

Essais cliniques associés

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Autres dossiers indiquant Onetexx Sdn Bhd en tant que demandeur

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Dispositifs connexes (Code : LZA)

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Source officielle

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