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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K223415 ↗

FDA Product Code

LZA

FDA applicant

Mah Sing Healthcare Sdn. Bhd.

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Nitrile Powder Free Blue Examination Gloves, Non-Sterile

  Class I

  FDA 510(k) K212535 Active Cleared 4 Dec 2021

• Tested For Use With Chemotherapy Drugs

  Class I

  FDA 510(k) K214110 Active Cleared 19 Feb 2022

• Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs

  Class I

  FDA 510(k) K230002 Active Cleared 24 Mar 2023

• Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue

  Class I

  FDA 510(k) K243694 Active Cleared 6 Jun 2025

• Mselect

  Class I

  CE/MDR

• Mselect

  Class I

  CE/MDR

See all devices from Mah Sing Healthcare Sdn Bhd →