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FDA 510(k)

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K-Number: K223415 · 2023-01-26

ApplicantMah Sing Healthcare Sdn. Bhd.
Decision Date2023-01-26
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device manufactured by Mah Sing Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2023-01-26 under approval number K223415. 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 Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2023-01-26. It is manufactured by Mah Sing Healthcare Sdn. Bhd.. The 510(k) number is K223415.

When was Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate approved by the FDA?

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2023-01-26, under approval number K223415.

What company makes Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is manufactured by Mah Sing Healthcare Sdn. Bhd..

What is the FDA product code for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, 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) PMID: 40854178 Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation. Academic medicine : journal of the Association of American Medical Colleges (2025) PMID: 39707817 Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices. Medical decision making : an international journal of the Society for Medical Decision Making (2025) PMID: 39556835 Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals of internal medicine (2024)

Other Devices by Mah Sing Healthcare Sdn. Bhd.

K212535Nitrile Powder Free Blue Examination Gloves, Non-Sterile K214110Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs K230002Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs K243694Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue

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

View on FDA Database →

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

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