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FDA 510(k)

Sterile Nitrile Surgical Gloves Powder Free

K-Number: K222350 · 2023-04-13

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2023-04-13
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Nitrile Surgical Gloves Powder Free is a medical device manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2023-04-13 under approval number K222350. 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 Nitrile Surgical Gloves Powder Free?

Sterile Nitrile Surgical Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2023-04-13. It is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K222350.

When was Sterile Nitrile Surgical Gloves Powder Free approved by the FDA?

Sterile Nitrile Surgical Gloves Powder Free received FDA 510(k) clearance on 2023-04-13, under approval number K222350.

What company makes Sterile Nitrile Surgical Gloves Powder Free?

Sterile Nitrile Surgical Gloves Powder Free is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd..

What is the FDA product code for Sterile Nitrile Surgical Gloves Powder Free?

The FDA product code for Sterile Nitrile Surgical Gloves Powder Free is KGO.

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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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