FDA 510(k)

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)

K-Number: K211758 · 2021-08-03

Decision Date2021-08-03

Product CodeOPC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a medical device manufactured by Hartalega NGC Sdn. Bhd.. It received FDA 510(k) clearance on 2021-08-03 under approval number K211758. The device is classified under product code OPC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)?

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a medical device that received FDA 510(k) clearance on 2021-08-03. It is manufactured by Hartalega NGC Sdn. Bhd.. The 510(k) number is K211758.

When was Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) approved by the FDA?

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) received FDA 510(k) clearance on 2021-08-03, under approval number K211758.

What company makes Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)?

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is manufactured by Hartalega NGC Sdn. Bhd..

What is the FDA product code for Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)?

The FDA product code for Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is OPC.

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Other Devices by Hartalega NGC Sdn. Bhd.

K151997Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) K172442Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) K170794Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) K162646Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) K162923NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE K192232Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.