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510(k) K864064

LATEX SURGICAL GLOVES by Futuremed Div. of Future Impex Corp. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1986
Date Received
October 20, 1986
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 Futuremed Div. of Future Impex Corp.

  • K933511 — UPGRADED SPIROMETER ST-90 (February 10, 1994)
  • K933220 — SELECTOR SL 01 (November 24, 1993)
  • K933222 — AUDIOMETER DA 323 (November 1, 1993)
  • K903017 — MEGA-TENS DUAL CHANNEL T.E.N.S. (October 26, 1990)
  • K901308 — SPIRO ANALYZER MODEL ST 250 (July 23, 1990)
  • K884972 — TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR (July 27, 1989)
  • K871421 — MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT (January 22, 1988)
  • K873817 — SPIRO ANALYZER ST-300 (December 2, 1987)
  • K872044 — CARBON ELECTRODE (July 16, 1987)
  • K872045 — CONDUCTIVITY GEL (July 15, 1987)

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)