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FDA 510(k)

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

K-Number: K171367 · 2018-01-26

ApplicantSanrea Healthcare Products Pvt, Ltd.
Decision Date2018-01-26
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) is a medical device manufactured by Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2018-01-26 under approval number K171367. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171367.

When was SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) approved by the FDA?

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

What company makes 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 manufactured by Sanrea Healthcare Products Pvt, Ltd..

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.

Related Clinical Trials

NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Other Devices by Sanrea Healthcare Products Pvt, Ltd.

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

Related Devices (Code: LYY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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