FDA 510(k)

Single-use medical latex examination gloves (LG100)

N.º K: K222693 · 2022-09-24

SolicitanteFitone Latex Products Co., Ltd. Guangdong

Fecha de decisión2022-09-24

Código de productoLYY

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Single-use medical latex examination gloves (LG100) is the device name listed in this FDA 510(k) record. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2022-09-24 under 510(k) number K222693. 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 Single-use medical latex examination gloves (LG100)?

Single-use medical latex examination gloves (LG100) is a medical device that received FDA 510(k) clearance on 2022-09-24. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K222693.

When did Single-use medical latex examination gloves (LG100) receive FDA 510(k) clearance?

Single-use medical latex examination gloves (LG100) received FDA 510(k) clearance on 2022-09-24, under 510(k) number K222693.

Who is the listed applicant for Single-use medical latex examination gloves (LG100)?

The FDA 510(k) record lists Fitone Latex Products Co., Ltd. Guangdong as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use medical latex examination gloves (LG100)?

The FDA product code for Single-use medical latex examination gloves (LG100) is LYY.

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Otros registros que enlistan a Fitone Latex Products Co., Ltd. Guangdong como solicitante

K231446Single-Use Latex Sterile Surgical Gloves (SG100)K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs K211927Nitrile examination gloves

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.

Fuente oficial

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