Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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

510(k) Number

K211816 ↗

FDA Product Code

LZA

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use with Chemotherapy Drugs

  Class I

  FDA 510(k) K162294 Active Cleared 21 Apr 2017

• Brightway Brand Blue Nitrile Examination Gloves (Powdered)

  Class I

  FDA 510(k) K990876 Active Cleared 23 Jun 1999

• Brightway Brand Nitrile Surgical Gloves - Sterile (Powdered)

  Class I

  FDA 510(k) K991940 Active Cleared 12 Jul 1999

• Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs

  Class I

  FDA 510(k) K170686 Active Cleared 14 Jul 2017

• Brightway Brand Latex Examination Glove-(Powdered, Sterile), Containing 150 Ugm or Less of Water Extractable Protein per

  Class I

  FDA 510(k) K032938 Active Cleared 20 Nov 2003

• Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey] with Chemotherapy Claim

  Class I

  FDA 510(k) K162186 Active Cleared 31 Mar 2017

See all devices from Brightway Holdings Sdn. Bhd. →