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510(k) K233560

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid by Eco Medi Glove Sdn. Bhd. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2024
Date Received
November 6, 2023
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 Eco Medi Glove Sdn. Bhd.

  • K232764 — Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemot (February 7, 2024)
  • K233405 — Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl (December 28, 2023)
  • K220943 — Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Dr (July 19, 2022)
  • K202401 — Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling cla (February 17, 2021)
  • K193121 — GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and w (March 20, 2020)
  • K181066 — Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with (September 26, 2018)
  • K171339 — EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemoth (July 7, 2017)
  • K161187 — EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemoth (September 9, 2016)
  • K161320 — EMG Pink Nitrile Examination Glove Powder Free (September 1, 2016)
  • K152937 — EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented (June 23, 2016)

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)