FDA 510(k)

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)

Numéro K : K211714 · 2021-08-04

DemandeurHengchang (Dongying) Medical Technology Co., Ltd.

Date de décision2021-08-04

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) is the device name listed in this FDA 510(k) record. The listed applicant is Hengchang (Dongying) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K211714. 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 Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)?

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Hengchang (Dongying) Medical Technology Co., Ltd.. The 510(k) number is K211714.

When did Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) receive FDA 510(k) clearance?

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) received FDA 510(k) clearance on 2021-08-04, under 510(k) number K211714.

Who is the listed applicant for Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)?

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

What is the FDA product code for Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)?

The FDA product code for Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) is LZA.

Essais cliniques associés

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Autres dossiers indiquant Hengchang (Dongying) Medical Technology Co., Ltd. en tant que demandeur

K211699Nitrile Exam Gloves, Powder Free, Blue

Dispositifs connexes (Code : LZA)

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Source officielle

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