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510(k) K241745

Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) by Ksg Medicare Sdn. Bhd. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2024
Date Received
June 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Other clearances by Ksg Medicare Sdn. Bhd.

  • K220209 — Powder Free Nitrile Examination Glove, Non-sterile (Blue) (April 11, 2022)
  • K220215 — Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemothe (March 26, 2022)

Other clearances for product code LZA

  • K253160 — Syntex Exam Gloves (January 23, 2026)
  • K252549 — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tes (January 13, 2026)
  • K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested (November 17, 2025)
  • K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fe (October 23, 2025)
  • K252075 — Program insite® Powder-Free, Disposable Nitrile Exam Gloves (October 17, 2025)
  • K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid F (August 27, 2025)
  • K252244 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use Wit (August 21, 2025)
  • K243604 — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, (August 18, 2025)
  • K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy D (July 30, 2025)
  • K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opi (July 9, 2025)