FDA 510(k)

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

Número K: K171367 · 2018-01-26

RequerenteSanrea Healthcare Products Pvt, Ltd.

Data da decisão2018-01-26

Código do produtoLYY

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Sanrea Healthcare Products Pvt, Ltd. como candidato(a)

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

Dispositivos Relacionados (Código: LYY)

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