Home / 510(k) Clearances / K222350

510(k) K222350

Sterile Nitrile Surgical Gloves Powder Free by Jr Engineering & Medical Technologies (M) Sdn. Bhd. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2023
Date Received
August 3, 2022
Clearance Type
Abbreviated
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 Jr Engineering & Medical Technologies (M) Sdn. Bhd.

  • K221626 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemoth (December 7, 2022)
  • K222348 — JR MEDIC (October 27, 2022)
  • K221169 — JR MEDIC Nitrile Examination Gloves Powder Free- Black (October 25, 2022)
  • K222349 — JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) (October 21, 2022)
  • K221157 — JR Medic (August 30, 2022)
  • K212827 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemoth (December 6, 2021)
  • K192328 — JR.MEDIK Latex Surgeon’s Gloves Powder Free (March 10, 2020)
  • K192333 — Blue Nitrile Examination Gloves Powder Free (January 24, 2020)
  • K192329 — Blue Latex Examination Powder Free Gloves (November 25, 2019)

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)