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FDA 510(k)

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs

Número K: K171276 · 2017-08-21

RequerenteTg Medical Sdn. Bhd.
Data da decisão2017-08-21
Código do produtoKGO
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Tg Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171276. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is Tg Medical Sdn. Bhd.. The 510(k) number is K171276.

When did Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171276.

Who is the listed applicant for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Tg Medical Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

The FDA product code for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is KGO.

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Dispositivos Relacionados (Código: KGO)

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