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FDA 510(k)

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K-Number: K213373 · 2022-03-10

ApplicantSmart Glove Corporation Sdn. Bhd.
Decision Date2022-03-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device manufactured by Smart Glove Corporation Sdn. Bhd.. It received FDA 510(k) clearance on 2022-03-10 under approval number K213373. 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 Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Smart Glove Corporation Sdn. Bhd.. The 510(k) number is K213373.

When was Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate approved by the FDA?

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2022-03-10, under approval number K213373.

What company makes Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is manufactured by Smart Glove Corporation Sdn. Bhd..

What is the FDA product code for Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is LZA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

Other Devices by Smart Glove Corporation Sdn. Bhd.

K171743Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves K180221Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs K183280PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs K181047Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs

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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