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FDA 510(k)

JR.MEDIK Latex Surgeon’s Gloves Powder Free

K-Number: K192328 · 2020-03-10

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2020-03-10
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JR.MEDIK Latex Surgeon’s Gloves Powder Free is a medical device manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2020-03-10 under approval number K192328. 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 JR.MEDIK Latex Surgeon’s Gloves Powder Free?

JR.MEDIK Latex Surgeon’s Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2020-03-10. It is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K192328.

When was JR.MEDIK Latex Surgeon’s Gloves Powder Free approved by the FDA?

JR.MEDIK Latex Surgeon’s Gloves Powder Free received FDA 510(k) clearance on 2020-03-10, under approval number K192328.

What company makes JR.MEDIK Latex Surgeon’s Gloves Powder Free?

JR.MEDIK Latex Surgeon’s Gloves Powder Free is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd..

What is the FDA product code for JR.MEDIK Latex Surgeon’s Gloves Powder Free?

The FDA product code for JR.MEDIK Latex Surgeon’s Gloves Powder Free is KGO.

Related Clinical Trials

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

Other Devices by Jr Engineering & Medical Technologies (M) Sdn. Bhd.

K192329Blue Latex Examination Powder Free Gloves K192333Blue Nitrile Examination Gloves Powder Free K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs K221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate K222348JR MEDIC K221169JR MEDIC Nitrile Examination Gloves Powder Free- Black

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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.

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