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510(k) K213548

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy by Mercator Medical (Thailand), Ltd. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2022
Date Received
November 8, 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 Mercator Medical (Thailand), Ltd.

  • K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested (November 17, 2025)
  • K200967 — mCare(R) Powder Free Nitrile Orange Examination Gloves (June 6, 2020)
  • K192444 — mCare® Powder Free Nitrile Black Examination Glove (December 31, 2019)
  • K190876 — mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeli (December 2, 2019)
  • K172930 — mCare Powder-free Blue Nitrile Examination Gloves (April 13, 2018)
  • K141042 — MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES (March 19, 2015)

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)