FDA 510(k)

Nitrile Gloves (Model: NE01)

Numéro K : K212840 · 2021-12-11

DemandeurByd Auto Industry Company Limited

Date de décision2021-12-11

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nitrile Gloves (Model: NE01) is the device name listed in this FDA 510(k) record. The listed applicant is Byd Auto Industry Company Limited. It received FDA 510(k) clearance on 2021-12-11 under 510(k) number K212840. 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 Gloves (Model: NE01)?

Nitrile Gloves (Model: NE01) is a medical device that received FDA 510(k) clearance on 2021-12-11. The listed applicant is Byd Auto Industry Company Limited. The 510(k) number is K212840.

When did Nitrile Gloves (Model: NE01) receive FDA 510(k) clearance?

Nitrile Gloves (Model: NE01) received FDA 510(k) clearance on 2021-12-11, under 510(k) number K212840.

Who is the listed applicant for Nitrile Gloves (Model: NE01)?

The FDA 510(k) record lists Byd Auto Industry Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Gloves (Model: NE01)?

The FDA product code for Nitrile Gloves (Model: NE01) is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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