Profeel Powder Free Nitrile Surgical Glove, Sterile

510(k) Number

K000971 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Profeel Powder Free

  Class IIa

  CE/MDR

• Dermagrip Black Nitrile

  Class I

  CE/MDR

• Comfit Powder Free

  Class IIa

  CE/MDR

• Powder Free Latex Examination Glove, Non-Sterile

  Class I

  FDA 510(k) K211601 Active Cleared 22 Aug 2022

• Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

  Class I

  FDA 510(k) K210330 Active Cleared 4 Mar 2022

• Dermagrip Sterile

  Class I

  CE/MDR

See all devices from WRP Asia Pacific Sdn. Bhd. →