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510(k) K250313

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid by Harps Europe Manufacturing GmbH — Product Code KGO

K250313 is an FDA 510(k) premarket notification submitted by Harps Europe Manufacturing GmbH for the device "Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid". The FDA issued a decision of Substantially Equivalent on August 19, 2025. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2025
Date Received
February 3, 2025
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 for product code KGO

  • K253060 — Sterile Latex Powder Free Surgical Gloves (May 22, 2026)
  • 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)

FDA data resources