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FDA 510(k)

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs

K-Number: K201774 · 2020-09-16

ApplicantPt. Medisafe Technologies
Decision Date2020-09-16
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs is a medical device manufactured by Pt. Medisafe Technologies. It received FDA 510(k) clearance on 2020-09-16 under approval number K201774. 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, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs?

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2020-09-16. It is manufactured by Pt. Medisafe Technologies. The 510(k) number is K201774.

When was Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs approved by the FDA?

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2020-09-16, under approval number K201774.

What company makes Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs?

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs is manufactured by Pt. Medisafe Technologies.

What is the FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs?

The FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs is KGO.

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Related PubMed Literature

PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Pt. Medisafe Technologies

K163041Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E K173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, 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.

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