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510(k) K112805

KIMGUARD ONE-STEP STERILIZATION WRAP by Kimberly-Clark Corp. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2012
Date Received
September 27, 2011
Clearance Type
Traditional
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

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  • 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)
  • K112562 — BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER (December 15, 2011)

Other clearances for product code FRG

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  • K242898 — Sterilization Pouches and Reels (February 21, 2025)