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510(k) K183287

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate by Kossan International Sdn Bhd — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2019
Date Received
November 26, 2018
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 Kossan International Sdn Bhd

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  • K232461 — Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use (November 14, 2023)
  • K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Pr (June 13, 2023)
  • K191800 — Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic (September 16, 2019)
  • K190606 — Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (May 28, 2019)
  • K181857 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low De (November 20, 2018)
  • K170397 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polyme (July 10, 2017)
  • K151750 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder (August 3, 2016)
  • K160467 — Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use wit (August 2, 2016)
  • K151824 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low De (August 2, 2016)

Other clearances for product code LZA

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  • 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)