FDA 510(k)

Nitrile Blue Powder-free Examination Glove

Numéro K : K211390 · 2021-08-28

Date de décision2021-08-28

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nitrile Blue Powder-free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2021-08-28 under 510(k) number K211390. 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 Nitrile Blue Powder-free Examination Glove?

Nitrile Blue Powder-free Examination Glove is a medical device that received FDA 510(k) clearance on 2021-08-28. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K211390.

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

Nitrile Blue Powder-free Examination Glove received FDA 510(k) clearance on 2021-08-28, under 510(k) number K211390.

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

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

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Dispositifs connexes (Code : LZA)

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Source officielle

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