Home / 510(k) Clearances / K052870

510(k) K052870

INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 by Kimberly-Clark Corp. — Product Code NZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2006
Date Received
October 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Microbial
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.

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)
  • K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP (January 19, 2012)

Other clearances for product code NZP

  • K223669 — SecurePortIV Advanced Catheter Securement Adhesive (June 12, 2023)
  • K170505 — SecurePortIV Catheter Securement Adhesive (September 29, 2017)
  • K083354 — FLORASEAL, MODEL FS350D (July 20, 2009)