FDA 510(k)

Medical Examination Gloves (Tested for Use with Chemotherapy)

Número K: K212506 · 2021-11-07

RequerenteGuangdong Gymda Medical Technology Co.,Ltd

Data da decisão2021-11-07

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Examination Gloves (Tested for Use with Chemotherapy) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Gymda Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-11-07 under 510(k) number K212506. 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 Medical Examination Gloves (Tested for Use with Chemotherapy)?

Medical Examination Gloves (Tested for Use with Chemotherapy) is a medical device that received FDA 510(k) clearance on 2021-11-07. The listed applicant is Guangdong Gymda Medical Technology Co.,Ltd. The 510(k) number is K212506.

When did Medical Examination Gloves (Tested for Use with Chemotherapy) receive FDA 510(k) clearance?

Medical Examination Gloves (Tested for Use with Chemotherapy) received FDA 510(k) clearance on 2021-11-07, under 510(k) number K212506.

Who is the listed applicant for Medical Examination Gloves (Tested for Use with Chemotherapy)?

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

What is the FDA product code for Medical Examination Gloves (Tested for Use with Chemotherapy)?

The FDA product code for Medical Examination Gloves (Tested for Use with Chemotherapy) is LZA.

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Outros registros que listam Guangdong Gymda Medical Technology Co.,Ltd como candidato(a)

K212078Medical Examination Gloves

Dispositivos Relacionados (Código: LZA)

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