FDA 510(k)

Powder Free Nitrile Examination Gloves (Blue)

Numéro K : K162113 · 2016-11-07

DemandeurNam Viet Glove Joint Stock Company

Date de décision2016-11-07

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Powder Free Nitrile Examination Gloves (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Nam Viet Glove Joint Stock Company. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K162113. 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 Powder Free Nitrile Examination Gloves (Blue)?

Powder Free Nitrile Examination Gloves (Blue) is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Nam Viet Glove Joint Stock Company. The 510(k) number is K162113.

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

Powder Free Nitrile Examination Gloves (Blue) received FDA 510(k) clearance on 2016-11-07, under 510(k) number K162113.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Blue)?

The FDA 510(k) record lists Nam Viet Glove Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue)?

The FDA product code for Powder Free Nitrile Examination Gloves (Blue) is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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