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510(k) K800152

SURGIKOS NEUTRALON BR. SURGEON'S GLOVE by Surgikos, Inc. — Product Code KGO

K800152 is an FDA 510(k) premarket notification submitted by Surgikos, Inc. for the device "SURGIKOS NEUTRALON BR. SURGEON'S GLOVE". The FDA issued a decision of Substantially Equivalent on February 19, 1980. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Surgikos, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1980
Date Received
January 22, 1980
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 Surgikos, Inc.

  • K875107 — HEALTH CARE EYE PROTECTION (March 21, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K861441 — NEUTRALON SURGICAL GLOVES (May 30, 1986)
  • K852870 — BARRIER SURGICAL GOWN (July 23, 1985)
  • K822535 — CIDEX*DIALYZER DISINFECTING SOLUTION (September 30, 1982)
  • K820543 — BARRIER ANTIMICROBIAL INCISE DRAPE (July 22, 1982)
  • K820542 — SURGIKOS INCISE DRAPE (June 2, 1982)
  • K811871 — BACTERICIDAL INCISE DRAPE (August 20, 1981)
  • K810316 — SURGIKOS FACE MASK (February 23, 1981)
  • K801864 — BARRIER APERTURED DRAPE (August 20, 1980)

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