510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K112805Substantially Equivalent

Kimguard One-Step Sterilization Wrap

Kimberly-Clark Corporation, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112805 is the FDA 510(k) clearance record for KIMGUARD ONE-STEP STERILIZATION WRAP, a class II device, cleared for Kimberly-Clark Corp. on under FDA product code FRG (Wrap, Sterilization). FDA records list 122 510(k) clearances for Kimberly-Clark Corp., from to . As of , FDA records show no recalls naming K112805.

Clearance record

Decision date
Received
(269 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Kimberly-Clark Corp. 1400 Holcomb Bridge Rd., Roswell GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260