Home / 510(k) Clearances / K112300

510(k) K112300

KIMGUARD SMART-FOLD* STERILIZATION WRAP by Kimberly-Clark Corp. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2012
Date Received
August 10, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Kimberly-Clark Corp.

  • K140963 — KIMGUARD SMART-FOLD STERILIZATION WRAP (November 10, 2014)
  • K141294 — U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS (August 25, 2014)
  • K131879 — KC 300 SURGICAL MASK (December 20, 2013)
  • K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE (November 7, 2013)
  • K131254 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE (August 20, 2013)
  • K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (December 19, 2012)
  • K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP (June 22, 2012)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
  • K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (March 9, 2012)
  • K112562 — BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER (December 15, 2011)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)