FDA 510(k)

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED

N.º K: K170094 · 2017-06-23

Fecha de decisión2017-06-23

Código de productoLYY

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED is the device name listed in this FDA 510(k) record. The listed applicant is Vietglove Corporation. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K170094. 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 GLOVE, POLYMER COATED?

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Vietglove Corporation. The 510(k) number is K170094.

When did POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED receive FDA 510(k) clearance?

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED received FDA 510(k) clearance on 2017-06-23, under 510(k) number K170094.

Who is the listed applicant for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED?

The FDA 510(k) record lists Vietglove Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED?

The FDA product code for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED is LYY.

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Otros registros que enlistan a Vietglove Corporation como solicitante

K201428Powder Free Black Nitrile Examination Glove K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less K153562Powder Free Blue Nitrile Examination Glove

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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