FDA 510(k)

Blue Nitrile Exam Gloves

Número K: K211341 · 2021-07-29

RequerenteJiangxi Surefine Medical Co., Ltd.

Data da decisão2021-07-29

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blue Nitrile Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Surefine Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211341. 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 Blue Nitrile Exam Gloves?

Blue Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Jiangxi Surefine Medical Co., Ltd.. The 510(k) number is K211341.

When did Blue Nitrile Exam Gloves receive FDA 510(k) clearance?

Blue Nitrile Exam Gloves received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211341.

Who is the listed applicant for Blue Nitrile Exam Gloves?

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

What is the FDA product code for Blue Nitrile Exam Gloves?

The FDA product code for Blue Nitrile Exam Gloves is LZA.

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