FDA 510(k)

Powder Free Blue Nitrile Examination Glove

Numéro K : K153732 · 2016-07-29

Date de décision2016-07-29

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Powder Free Blue Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Qube Medical Product Sdn Bhd. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K153732. 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 Blue Nitrile Examination Glove?

Powder Free Blue Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Qube Medical Product Sdn Bhd. The 510(k) number is K153732.

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

Powder Free Blue Nitrile Examination Glove received FDA 510(k) clearance on 2016-07-29, under 510(k) number K153732.

Who is the listed applicant for Powder Free Blue Nitrile Examination Glove?

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

What is the FDA product code for Powder Free Blue Nitrile Examination Glove?

The FDA product code for Powder Free Blue Nitrile Examination Glove is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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