FDA 510(k)

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)

Numéro K : K223437 · 2023-05-17

Date de décision2023-05-17

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (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 2023-05-17 under 510(k) number K223437. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)?

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a medical device that received FDA 510(k) clearance on 2023-05-17. The listed applicant is Hartalega NGC Sdn. Bhd.. The 510(k) number is K223437.

When did Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) receive FDA 510(k) clearance?

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) received FDA 510(k) clearance on 2023-05-17, under 510(k) number K223437.

Who is the listed applicant for Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (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 Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)?

The FDA product code for Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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