Home / 510(k) Clearances / K201592

510(k) K201592

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove by Cardinal Health200, LLC — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2021
Date Received
June 12, 2020
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 Cardinal Health200, LLC

  • K241780 — Cardinal Health Nitrile Exam Gloves (August 23, 2024)
  • K230838 — Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrumen (July 27, 2023)
  • K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject M (June 21, 2023)
  • K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD E (April 3, 2023)
  • K211390 — Nitrile Blue Powder-free Examination Glove (August 28, 2021)
  • K200824 — Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AI (July 29, 2020)
  • K193327 — Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health Chemo (March 20, 2020)
  • K192374 — Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (December 2, 2019)
  • K182830 — Cardinal HealthTM Poly-Coated Open-Back Protective Gown (April 26, 2019)
  • K181174 — Cardinal Health Sterilization Wrap (December 11, 2018)

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)