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 the device name listed in this FDA 510(k) record. The listed applicant is Hartalega NGC Sdn. Bhd.. It received FDA 510(k) clearance on 2021-08-03 under 510(k) 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. The listed applicant is Hartalega NGC Sdn. Bhd.. The 510(k) number is K211758.

When did Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) receive FDA 510(k) clearance?

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

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

The FDA 510(k) record lists Hartalega NGC Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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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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.