FDA 510(k)

Disposable Nitrile Medical Powder-free Glove

Numéro K : K213187 · 2022-01-03

DemandeurFujian Chunhui Medical Supply Co., Ltd.

Date de décision2022-01-03

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Nitrile Medical Powder-free Glove is the device name listed in this FDA 510(k) record. The listed applicant is Fujian Chunhui Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-01-03 under 510(k) number K213187. 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 Disposable Nitrile Medical Powder-free Glove?

Disposable Nitrile Medical Powder-free Glove is a medical device that received FDA 510(k) clearance on 2022-01-03. The listed applicant is Fujian Chunhui Medical Supply Co., Ltd.. The 510(k) number is K213187.

When did Disposable Nitrile Medical Powder-free Glove receive FDA 510(k) clearance?

Disposable Nitrile Medical Powder-free Glove received FDA 510(k) clearance on 2022-01-03, under 510(k) number K213187.

Who is the listed applicant for Disposable Nitrile Medical Powder-free Glove?

The FDA 510(k) record lists Fujian Chunhui Medical Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Medical Powder-free Glove?

The FDA product code for Disposable Nitrile Medical Powder-free Glove is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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