FDA 510(k)

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

Número K: K212482 · 2022-08-09

RequerenteSri Trang Gloves (Thailand) Public Company Limited

Data da decisão2022-08-09

Código do produtoLYY

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White 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 2022-08-09 under 510(k) number K212482. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K212482.

When did Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White receive FDA 510(k) clearance?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White received FDA 510(k) clearance on 2022-08-09, under 510(k) number K212482.

Who is the listed applicant for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

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 Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

The FDA product code for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is LYY.

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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 K212309Non-sterile, Powder-Free Latex Examination Glove K200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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