FDA 510(k)

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)

N.º K: K171367 · 2018-01-26

SolicitanteSanrea Healthcare Products Pvt, Ltd.

Fecha de decisión2018-01-26

Código de productoLYY

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) is the device name listed in this FDA 510(k) record. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K171367. 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 SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)?

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171367.

When did SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) receive FDA 510(k) clearance?

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) received FDA 510(k) clearance on 2018-01-26, under 510(k) number K171367.

Who is the listed applicant for SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)?

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

What is the FDA product code for SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)?

The FDA product code for SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) is LYY.

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Otros registros que enlistan a Sanrea Healthcare Products Pvt, Ltd. como solicitante

K171550Sterile Latex Surgical Gloves, Powder Free K171093STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE

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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