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510(k) K230079

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential by Ansell Healthcare Products, LLC — Product Code KGO

K230079 is an FDA 510(k) premarket notification submitted by Ansell Healthcare Products, LLC for the device "Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential". The FDA issued a decision of Substantially Equivalent on August 23, 2023. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Ansell Healthcare Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2023
Date Received
January 10, 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 Ansell Healthcare Products, LLC

  • K213289 — Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (May 26, 2023)
  • K212148 — Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use (March 10, 2022)
  • K210401 — Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Ch (June 13, 2021)
  • K200671 — Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green (June 19, 2020)
  • K190018 — Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemo (May 23, 2019)
  • K182948 — Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (March 22, 2019)
  • K171375 — Gammex PI Breach Detect Powder Free Surgical Glove (February 6, 2018)
  • K171737 — Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves (December 29, 2017)
  • K171172 — Skyn Original Polyisoprene Lubricated Male Condom - Flavored (August 2, 2017)
  • K163107 — Lifestyles Zero Lubricated Latex Male Condom (January 23, 2017)

Other clearances for product code KGO

  • K253060 — Sterile Latex Powder Free Surgical Gloves (May 22, 2026)
  • 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)
  • K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green (August 18, 2023)

FDA data resources