FDA 510(k)

Powder Free Nitrile Examination Gloves (Black)

Número K: K232353 · 2023-08-31

RequerenteShanxi Hongjin Plastic Technology Co., Ltd.

Data da decisão2023-08-31

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Nitrile Examination Gloves (Black) is the device name listed in this FDA 510(k) record. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K232353. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Powder Free Nitrile Examination Gloves (Black)?

Powder Free Nitrile Examination Gloves (Black) is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. The 510(k) number is K232353.

When did Powder Free Nitrile Examination Gloves (Black) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Black) received FDA 510(k) clearance on 2023-08-31, under 510(k) number K232353.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Black)?

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

What is the FDA product code for Powder Free Nitrile Examination Gloves (Black)?

The FDA product code for Powder Free Nitrile Examination Gloves (Black) is LZA.

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Outros registros que listam Shanxi Hongjin Plastic Technology Co., Ltd. como candidato(a)

K232550Nitrile Examination Gloves, Dual Color Black-Blue K230779Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K220229Powder Free Nitrile Examination Gloves, Orange K211604Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs K180381Powder Free Vinyl Patient Examination Gloves K180260Powder Free Vinyl Patient Examination Gloves (Yellow, White)

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Dispositivos Relacionados (Código: LZA)

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