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FDA 510(k)

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove

K-Number: K183389 · 2019-06-28

ApplicantHartalega NGC Sdn. Bhd.
Decision Date2019-06-28
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove is a medical device manufactured by Hartalega NGC Sdn. Bhd.. It received FDA 510(k) clearance on 2019-06-28 under approval number K183389. 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 Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove?

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Hartalega NGC Sdn. Bhd.. The 510(k) number is K183389.

When was Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove approved by the FDA?

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove received FDA 510(k) clearance on 2019-06-28, under approval number K183389.

What company makes Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove?

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove is manufactured by Hartalega NGC Sdn. Bhd..

What is the FDA product code for Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove?

The FDA product code for Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove 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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