FDA 510(k)

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate

K-Number: K222181 · 2023-01-11

Decision Date2023-01-11

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is a medical device manufactured by Iconic Medicare Sdn Bhd. It received FDA 510(k) clearance on 2023-01-11 under approval number K222181. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2023-01-11. It is manufactured by Iconic Medicare Sdn Bhd. The 510(k) number is K222181.

When was Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate approved by the FDA?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate received FDA 510(k) clearance on 2023-01-11, under approval number K222181.

What company makes Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is manufactured by Iconic Medicare Sdn Bhd.

What is the FDA product code for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

The FDA product code for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is LZA.

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Other Devices by Iconic Medicare Sdn Bhd

K212182Iconic Nitrile Glove K221648Iconic Latex Glove

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

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.