FDA 510(k)

Blue Nitrile Exam Glove, Powder Free

Numéro K : K210058 · 2021-03-30

DemandeurGreat Harvest Trading Co., Ltd.

Date de décision2021-03-30

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Blue Nitrile Exam Glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Great Harvest Trading Co., Ltd.. It received FDA 510(k) clearance on 2021-03-30 under 510(k) number K210058. 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 Blue Nitrile Exam Glove, Powder Free?

Blue Nitrile Exam Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2021-03-30. The listed applicant is Great Harvest Trading Co., Ltd.. The 510(k) number is K210058.

When did Blue Nitrile Exam Glove, Powder Free receive FDA 510(k) clearance?

Blue Nitrile Exam Glove, Powder Free received FDA 510(k) clearance on 2021-03-30, under 510(k) number K210058.

Who is the listed applicant for Blue Nitrile Exam Glove, Powder Free?

The FDA 510(k) record lists Great Harvest Trading Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Nitrile Exam Glove, Powder Free?

The FDA product code for Blue Nitrile Exam Glove, Powder Free is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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