FDA 510(k)

Powder-Free Latex examination gloves

N.º K: K222612 · 2022-11-25

SolicitanteGuangdong Kingfa Sci. & Tech.Co., Ltd.

Fecha de decisión2022-11-25

Código de productoLYY

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder-Free Latex examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2022-11-25 under 510(k) number K222612. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Powder-Free Latex examination gloves?

Powder-Free Latex examination gloves is a medical device that received FDA 510(k) clearance on 2022-11-25. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K222612.

When did Powder-Free Latex examination gloves receive FDA 510(k) clearance?

Powder-Free Latex examination gloves received FDA 510(k) clearance on 2022-11-25, under 510(k) number K222612.

Who is the listed applicant for Powder-Free Latex examination gloves?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-Free Latex examination gloves?

The FDA product code for Powder-Free Latex examination gloves is LYY.

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Otros registros que enlistan a Guangdong Kingfa Sci. & Tech.Co., Ltd. como solicitante

K233723Medical surgical mask K231155Biodegradable Medical surgical mask K221983Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color K230046Vinyl examination gloves K222714Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs K221887Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color

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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.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.K222348JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd.

Fuente oficial

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