FDA 510(k)

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

Número K: K211667 · 2021-09-23

RequerenteChangzhou Universal Medical Equipment Co., Ltd.

Data da decisão2021-09-23

Código do produtoLAZ

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211667. The device is classified under product code LAZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K211667.

When did Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) receive FDA 510(k) clearance?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211667.

Who is the listed applicant for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

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

What is the FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

The FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is LAZ.

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