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510(k) K211022

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. by Central Medicare Sdn Bhd — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2021
Date Received
April 5, 2021
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 Central Medicare Sdn Bhd

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  • K230875 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chem (July 20, 2023)
  • K230564 — Green Non Sterile Powder Free Nitrile Examination Gloves (May 23, 2023)
  • K213437 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chem (April 11, 2022)
  • K203036 — Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) (May 7, 2021)
  • K183149 — Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low (July 4, 2019)
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  • K172642 — Orange Non Sterile Powder Free Nitrile Examination Gloves (November 28, 2017)
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Other clearances for product code LZA

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  • 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)