FDA 510(k)

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy

K-Number: K173258 · 2018-04-20

Decision Date2018-04-20

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy is a medical device manufactured by Pt. Medisafe Technologies. It received FDA 510(k) clearance on 2018-04-20 under approval number K173258. 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 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy?

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy is a medical device that received FDA 510(k) clearance on 2018-04-20. It is manufactured by Pt. Medisafe Technologies. The 510(k) number is K173258.

When was Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy approved by the FDA?

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy received FDA 510(k) clearance on 2018-04-20, under approval number K173258.

What company makes Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy?

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy is manufactured by Pt. Medisafe Technologies.

What is the FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy?

The FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy is KGO.

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Other Devices by Pt. Medisafe Technologies

K163041Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs K201774Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs

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

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