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510(k) K230578

Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl by Wrp Asia Pacific Sdn. Bhd. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2023
Date Received
March 1, 2023
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 Wrp Asia Pacific Sdn. Bhd.

  • K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with C (March 28, 2024)
  • K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE (November 17, 2023)
  • K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemother (October 22, 2022)
  • K211601 — Powder Free Latex Examination Glove, Non-Sterile (August 22, 2022)
  • K210330 — Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with C (March 4, 2022)
  • K203030 — POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DR (June 11, 2021)
  • K192635 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (January 17, 2020)
  • K161823 — Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Dr (January 23, 2017)
  • K161422 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TEST (October 20, 2016)
  • K141982 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TEST (February 5, 2015)

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)
  • 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)
  • K230832 — Powdered Free Sterile Natural Rubber Latex Surgical Gloves (August 16, 2023)