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FDA 510(k)

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs

K-Number: K171276 · 2017-08-21

ApplicantTg Medical Sdn. Bhd.
Decision Date2017-08-21
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is a medical device manufactured by Tg Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2017-08-21 under approval number K171276. 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 Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-08-21. It is manufactured by Tg Medical Sdn. Bhd.. The 510(k) number is K171276.

When was Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs approved by the FDA?

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-08-21, under approval number K171276.

What company makes Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is manufactured by Tg Medical Sdn. Bhd..

What is the FDA product code for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

The FDA product code for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is KGO.

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Related PubMed Literature

PMID: 29602568 Evaluation of Ophthalmic Surgical Instrument Sterility Using Short-Cycle Sterilization for Sequential Same-Day Use. Ophthalmology (2018)

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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