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FDA 510(k)

Gammex PI Hybrid Surgical Gloves

K-Number: K151694 · 2016-03-09

ApplicantAnsell Healthcare Products, LLC
Decision Date2016-03-09
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gammex PI Hybrid Surgical Gloves is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2016-03-09 under approval number K151694. 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 Hybrid Surgical Gloves?

Gammex PI Hybrid Surgical Gloves is a medical device that received FDA 510(k) clearance on 2016-03-09. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K151694.

When was Gammex PI Hybrid Surgical Gloves approved by the FDA?

Gammex PI Hybrid Surgical Gloves received FDA 510(k) clearance on 2016-03-09, under approval number K151694.

What company makes Gammex PI Hybrid Surgical Gloves?

Gammex PI Hybrid Surgical Gloves is manufactured by Ansell Healthcare Products, LLC.

What is the FDA product code for Gammex PI Hybrid Surgical Gloves?

The FDA product code for Gammex PI Hybrid Surgical Gloves is KGO.

Related Clinical Trials

NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

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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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