Home / 510(k) Clearances / K190241

510(k) K190241

Sterile Latex Surgical Glove, Powder Free by Careglove Global Sdn. Bhd. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2019
Date Received
February 6, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgeon'S Gloves
Device Class
Class I
Regulation Number
878.4460
Review Panel
HO
Submission Type

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Other clearances by Careglove Global Sdn. Bhd.

  • K250578 — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & (April 1, 2025)
  • K230121 — Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & (May 15, 2023)
  • K220859 — Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & (September 9, 2022)
  • K213993 — Powder Free Chloroprene Examination Glove Coloured (Blue, Green) (August 5, 2022)
  • K211666 — Powder Free Nitrile Examination Gloves, Blue Chemotest (January 9, 2022)
  • K172015 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) (September 26, 2017)
  • K161833 — LATEX EXAMINATION GLOVE POWDER FREE (May 23, 2017)

Other clearances for product code KGO

  • K250313 — Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For U (August 19, 2025)
  • K240790 — Polyisoprene Surgical gloves (August 23, 2024)
  • K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with C (March 28, 2024)
  • K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drug (December 20, 2023)
  • K231902 — GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX P (October 20, 2023)
  • K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (September 29, 2023)
  • K231446 — Single-Use Latex Sterile Surgical Gloves (SG100) (September 22, 2023)
  • K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with (August 31, 2023)
  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)
  • K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green (August 18, 2023)