FDA 510(k)

Disposable Medical Nitrile Examination Gloves

Numéro K : K213912 · 2022-02-19

DemandeurJiangsu Maolin Medical Technology Co., Ltd.

Date de décision2022-02-19

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Medical Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Maolin Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K213912. 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 Medical Nitrile Examination Gloves?

Disposable Medical Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Jiangsu Maolin Medical Technology Co., Ltd.. The 510(k) number is K213912.

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

Disposable Medical Nitrile Examination Gloves received FDA 510(k) clearance on 2022-02-19, under 510(k) number K213912.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves?

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

What is the FDA product code for Disposable Medical Nitrile Examination Gloves?

The FDA product code for Disposable Medical Nitrile Examination Gloves is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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