Home / 510(k) Clearances / K112257

510(k) K112257

BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE by Molnlycke Health Care Us, LLC — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2011
Date Received
August 5, 2011
Clearance Type
Special
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 Molnlycke Health Care Us, LLC

  • K232508 — Barrier EasyWarm Active Self-Warming Blanket (September 15, 2023)
  • K203369 — Avance Solo Negative Pressure Wound Therapy (NPWT) System (July 1, 2021)
  • K202090 — Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel I (November 22, 2020)
  • K193573 — Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator (April 10, 2020)
  • K191869 — Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, (March 13, 2020)
  • K190077 — Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Under (May 24, 2019)
  • K161939 — Avance Abdominal Dressing Kit (November 17, 2016)
  • K161935 — Avance Foam Dressing Kit - XL (November 4, 2016)
  • K161948 — Avance Gauze Dressing Kits (November 3, 2016)
  • K161797 — Avance Tubing, Avance Y-Connector, Avance ViewPad (October 19, 2016)

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)