FDA 510(k)

Disposable Nitrile Examination Glove

Numéro K : K212661 · 2021-11-19

DemandeurInner Mongolia Cureguard Medical Technology Co., Ltd.

Date de décision2021-11-19

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 Inner Mongolia Cureguard Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K212661. 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 2021-11-19. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. The 510(k) number is K212661.

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

Disposable Nitrile Examination Glove received FDA 510(k) clearance on 2021-11-19, under 510(k) number K212661.

Who is the listed applicant for Disposable Nitrile Examination Glove?

The FDA 510(k) record lists Inner Mongolia Cureguard Medical Technology 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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Autres dossiers indiquant Inner Mongolia Cureguard Medical Technology Co., Ltd. en tant que demandeur

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Dispositifs connexes (Code : LZA)

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Source officielle

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