FDA 510(k)

LATEX EXAMINATION GLOVE POWDER FREE

N.º K: K161833 · 2017-05-23

Fecha de decisión2017-05-23

Código de productoLYY

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

LATEX EXAMINATION GLOVE POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K161833. 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 LATEX EXAMINATION GLOVE POWDER FREE?

LATEX EXAMINATION GLOVE POWDER FREE is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Careglove Global Sdn. Bhd.. The 510(k) number is K161833.

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

LATEX EXAMINATION GLOVE POWDER FREE received FDA 510(k) clearance on 2017-05-23, under 510(k) number K161833.

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

The FDA 510(k) record lists Careglove Global Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Otros registros que enlistan a Careglove Global Sdn. Bhd. como solicitante

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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.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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