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FDA 510(k)

Gammex PI Breach Detect Powder Free Surgical Glove

K-Number: K171375 · 2018-02-06

ApplicantAnsell Healthcare Products, LLC
Decision Date2018-02-06
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gammex PI Breach Detect Powder Free Surgical Glove is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2018-02-06 under approval number K171375. 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 Gammex PI Breach Detect Powder Free Surgical Glove?

Gammex PI Breach Detect Powder Free Surgical Glove is a medical device that received FDA 510(k) clearance on 2018-02-06. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K171375.

When was Gammex PI Breach Detect Powder Free Surgical Glove approved by the FDA?

Gammex PI Breach Detect Powder Free Surgical Glove received FDA 510(k) clearance on 2018-02-06, under approval number K171375.

What company makes Gammex PI Breach Detect Powder Free Surgical Glove?

Gammex PI Breach Detect Powder Free Surgical Glove is manufactured by Ansell Healthcare Products, LLC.

What is the FDA product code for Gammex PI Breach Detect Powder Free Surgical Glove?

The FDA product code for Gammex PI Breach Detect Powder Free Surgical Glove is KGO.

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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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