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510(k) K251319

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff by Hartalega NGC Sdn. Bhd. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2025
Date Received
April 29, 2025
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 Hartalega NGC Sdn. Bhd.

  • K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fe (October 23, 2025)
  • K243818 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and (January 8, 2025)
  • K223437 — Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemothe (May 17, 2023)
  • K222225 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Bl (November 11, 2022)
  • K221718 — Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs ( (September 24, 2022)
  • K214074 — Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or (May 26, 2022)
  • K211758 — Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy D (August 3, 2021)
  • K201772 — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and T (August 25, 2020)
  • K201530 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and (August 5, 2020)
  • K200581 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemoth (April 25, 2020)

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)
  • K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opi (July 9, 2025)
  • K250342 — Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with (July 8, 2025)