FDA 510(k)

Amazing+ Luvas de Exame de Latex Livre

Número K: K212597 · 2022-05-28

RequerenteAmazing Rubber Products Pvt, Ltd.

Data da decisão2022-05-28

Código do produtoLYY

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Amazing+ Latex Examination Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Amazing Rubber Products Pvt, Ltd.. It received FDA 510(k) clearance on 2022-05-28 under 510(k) number K212597. 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 Amazing+ Latex Examination Powder Free Gloves?

Amazing+ Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2022-05-28. The listed applicant is Amazing Rubber Products Pvt, Ltd.. The 510(k) number is K212597.

When did Amazing+ Latex Examination Powder Free Gloves receive FDA 510(k) clearance?

Amazing+ Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2022-05-28, under 510(k) number K212597.

Who is the listed applicant for Amazing+ Latex Examination Powder Free Gloves?

The FDA 510(k) record lists Amazing Rubber Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amazing+ Latex Examination Powder Free Gloves?

The FDA product code for Amazing+ Latex Examination Powder Free Gloves is LYY.

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Outros registros que listam Amazing Rubber Products Pvt, Ltd. como candidato(a)

K212584Blue Nitrile Examination Gloves Powder Free K212596Sterile Latex Surgical Gloves Powder Free K212586Amazing+

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.

Fonte oficial

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