FDA 510(k)

Disposable Medical Nitrile Examination Gloves

Número K: K223895 · 2023-03-23

RequerenteHebei Titans Hongsen Medical Technology Co., Ltd.

Data da decisão2023-03-23

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Medical Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K223895. 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 Disposable Medical Nitrile Examination Gloves?

Disposable Medical Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K223895.

When did Disposable Medical Nitrile Examination Gloves receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves received FDA 510(k) clearance on 2023-03-23, under 510(k) number K223895.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves?

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

What is the FDA product code for Disposable Medical Nitrile Examination Gloves?

The FDA product code for Disposable Medical Nitrile Examination Gloves is LZA.

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Outros registros que listam Hebei Titans Hongsen Medical Technology Co., Ltd. como candidato(a)

K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)K212097Disposable medical surgical mask K211229Vinyl compound examination gloves K182043Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

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Dispositivos Relacionados (Código: LZA)

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Fonte oficial

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