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FDA 510(k)

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

K-Number: K160781 · 2017-05-02

ApplicantSemperit Investments Asia Pte , Ltd.
Decision Date2017-05-02
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is a medical device manufactured by Semperit Investments Asia Pte , Ltd.. It received FDA 510(k) clearance on 2017-05-02 under approval number K160781. 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 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is a medical device that received FDA 510(k) clearance on 2017-05-02. It is manufactured by Semperit Investments Asia Pte , Ltd.. The 510(k) number is K160781.

When was Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves approved by the FDA?

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves received FDA 510(k) clearance on 2017-05-02, under approval number K160781.

What company makes Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is manufactured by Semperit Investments Asia Pte , Ltd..

What is the FDA product code for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

The FDA product code for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is KGO.

Related Clinical Trials

NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Other Devices by Semperit Investments Asia Pte , Ltd.

K171378Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs K183441Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)

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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