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FDA 510(k)

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)

K-Number: K200897 · 2020-06-01

ApplicantHartalega Sdn Bhd
Decision Date2020-06-01
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is a medical device manufactured by Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2020-06-01 under approval number K200897. 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 Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is a medical device that received FDA 510(k) clearance on 2020-06-01. It is manufactured by Hartalega Sdn Bhd. The 510(k) number is K200897.

When was Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) approved by the FDA?

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) received FDA 510(k) clearance on 2020-06-01, under approval number K200897.

What company makes Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is manufactured by Hartalega Sdn Bhd.

What is the FDA product code for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

The FDA product code for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is KGO.

Related Clinical Trials

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Other Devices by Hartalega Sdn Bhd

K160560Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE K173137Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) K171874Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) K170152POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)

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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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