Home / 510(k) Clearances / K250069

510(k) K250069

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein by Comfort Rubber Gloves Industries Sdn. Bhd. — Product Code LYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2025
Date Received
January 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Latex Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A latex patient examination glove is a disposable device made of natural rubber latex 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 Comfort Rubber Gloves Industries Sdn. Bhd.

  • K240269 — Nitrile Powder Free Examination Gloves Biodegradable (Green) (October 25, 2024)
  • K241528 — Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potent (August 6, 2024)
  • K192954 — Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and (June 19, 2020)
  • K200181 — Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemoth (April 15, 2020)
  • K190080 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs La (June 27, 2019)
  • K180476 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (May 15, 2018)
  • K171541 — Powder Free Nitrile Examination Gloves (Orange) (September 20, 2017)
  • K162405 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs La (March 28, 2017)
  • K110297 — POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES (June 15, 2011)
  • K101917 — COMFORT RUBBER GLOVES IND.SDN.BHD. (October 29, 2010)

Other clearances for product code LYY

  • K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (September 9, 2024)
  • K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Pr (June 13, 2023)
  • K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (February 22, 2023)
  • K222612 — Powder-Free Latex examination gloves (November 25, 2022)
  • K221667 — Non Sterile Powder Free Latex Examination Glove (October 28, 2022)
  • K222348 — JR MEDIC (October 27, 2022)
  • K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (October 26, 2022)
  • K222693 — Single-use medical latex examination gloves (LG100) (September 24, 2022)
  • K221648 — Iconic Latex Glove (August 25, 2022)
  • K211601 — Powder Free Latex Examination Glove, Non-Sterile (August 22, 2022)