FDA 510(k)

Disposable Nitrile Examination Glove

Numéro K : K223250 · 2023-01-19

DemandeurYangzhou Saraguard Medical Supplies Co., Ltd.

Date de décision2023-01-19

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Saraguard Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K223250. 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 Examination Glove?

Disposable Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Yangzhou Saraguard Medical Supplies Co., Ltd.. The 510(k) number is K223250.

When did Disposable Nitrile Examination Glove receive FDA 510(k) clearance?

Disposable Nitrile Examination Glove received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223250.

Who is the listed applicant for Disposable Nitrile Examination Glove?

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

What is the FDA product code for Disposable Nitrile Examination Glove?

The FDA product code for Disposable 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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