FDA 510(k)

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

K-Number: K182948 · 2019-03-22

ApplicantAnsell Healthcare Products, LLC

Decision Date2019-03-22

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2019-03-22 under approval number K182948. 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 Tested for Use with Chemotherapy Drugs?

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K182948.

When was Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs approved by the FDA?

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-03-22, under approval number K182948.

What company makes Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs?

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs is manufactured by Ansell Healthcare Products, LLC.

What is the FDA product code for Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs?

The FDA product code for Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs 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.