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510(k) K171375

Gammex PI Breach Detect Powder Free Surgical Glove by Ansell Healthcare Products, LLC — Product Code KGO

K171375 is an FDA 510(k) premarket notification submitted by Ansell Healthcare Products, LLC for the device "Gammex PI Breach Detect Powder Free Surgical Glove". The FDA issued a decision of Substantially Equivalent on February 6, 2018. 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
February 6, 2018
Date Received
May 10, 2017
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

  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)
  • 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)
  • 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)
  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)

FDA data resources