FDA 510(k)

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

Número K: K200539 · 2020-04-09

RequerenteSri Trang Gloves (Thailand) Public Company Limited

Data da decisão2020-04-09

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K200539. 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 Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K200539.

When did Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl receive FDA 510(k) clearance?

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance on 2020-04-09, under 510(k) number K200539.

Who is the listed applicant for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?

The FDA 510(k) record lists Sri Trang Gloves (Thailand) Public Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?

The FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is LZA.

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Outros registros que listam Sri Trang Gloves (Thailand) Public Company Limited como candidato(a)

K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)K240930Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue K232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl K212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White K212309Non-sterile, Powder-Free Latex Examination Glove

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Dispositivos Relacionados (Código: LZA)

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