FDA 510(k)

Nitrile Examination Gloves, Dual Color Black-Blue

Número K: K232550 · 2023-10-20

RequerenteShanxi Hongjin Plastic Technology Co., Ltd.

Data da decisão2023-10-20

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Examination Gloves, Dual Color Black-Blue 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 2023-10-20 under 510(k) number K232550. 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 Nitrile Examination Gloves, Dual Color Black-Blue?

Nitrile Examination Gloves, Dual Color Black-Blue is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. The 510(k) number is K232550.

When did Nitrile Examination Gloves, Dual Color Black-Blue receive FDA 510(k) clearance?

Nitrile Examination Gloves, Dual Color Black-Blue received FDA 510(k) clearance on 2023-10-20, under 510(k) number K232550.

Who is the listed applicant for Nitrile Examination Gloves, Dual Color Black-Blue?

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 Nitrile Examination Gloves, Dual Color Black-Blue?

The FDA product code for Nitrile Examination Gloves, Dual Color Black-Blue is LZA.

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

K232353Powder Free Nitrile Examination Gloves (Black)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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