Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Nitrile Powder Free Blue Examination Gloves, Non-Sterile

K-Number: K212535 · 2021-12-04

ApplicantMah Sing Healthcare Sdn. Bhd.
Decision Date2021-12-04
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Blue Examination Gloves, Non-Sterile is a medical device manufactured by Mah Sing Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2021-12-04 under approval number K212535. 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 Examination Gloves, Non-Sterile?

Nitrile Powder Free Blue Examination Gloves, Non-Sterile is a medical device that received FDA 510(k) clearance on 2021-12-04. It is manufactured by Mah Sing Healthcare Sdn. Bhd.. The 510(k) number is K212535.

When was Nitrile Powder Free Blue Examination Gloves, Non-Sterile approved by the FDA?

Nitrile Powder Free Blue Examination Gloves, Non-Sterile received FDA 510(k) clearance on 2021-12-04, under approval number K212535.

What company makes Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

Nitrile Powder Free Blue Examination Gloves, Non-Sterile is manufactured by Mah Sing Healthcare Sdn. Bhd..

What is the FDA product code for Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

The FDA product code for Nitrile Powder Free Blue Examination Gloves, Non-Sterile is LZA.

Related Clinical Trials

NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by Mah Sing Healthcare Sdn. Bhd.

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 K223415Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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.

↑