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FDA 510(k)

Sterile Latex Surgical Gloves, Powder Free

K-Number: K171550 · 2018-07-13

ApplicantSanrea Healthcare Products Pvt, Ltd.
Decision Date2018-07-13
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Latex Surgical Gloves, Powder Free is a medical device manufactured by Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2018-07-13 under approval number K171550. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Latex Surgical Gloves, Powder Free?

Sterile Latex Surgical Gloves, Powder Free is a medical device that received FDA 510(k) clearance on 2018-07-13. It is manufactured by Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171550.

When was Sterile Latex Surgical Gloves, Powder Free approved by the FDA?

Sterile Latex Surgical Gloves, Powder Free received FDA 510(k) clearance on 2018-07-13, under approval number K171550.

What company makes Sterile Latex Surgical Gloves, Powder Free?

Sterile Latex Surgical Gloves, Powder Free is manufactured by Sanrea Healthcare Products Pvt, Ltd..

What is the FDA product code for Sterile Latex Surgical Gloves, Powder Free?

The FDA product code for Sterile Latex Surgical Gloves, Powder Free is KGO.

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Other Devices by Sanrea Healthcare Products Pvt, Ltd.

K171093STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE K171367SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)

Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, Inc.

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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