Cleared Traditional

KIMGUARD ONE STEP STERILIZATION WRAP

K141712 · Halyard Health · General Hospital
Dec 2014
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K141712 is an FDA 510(k) clearance for the KIMGUARD ONE STEP STERILIZATION WRAP, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Halyard Health (Minneapolis, US). The FDA issued a Cleared decision on December 18, 2014, 176 days after receiving the submission on June 25, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K141712 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2014
Decision Date December 18, 2014
Days to Decision 176 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

Similar Devices — FRG Wrap, Sterilization

All 319
Sterilization Pouch/Roll
K251347 · Sterivic Medical Co., Ltd. · Jan 2026
Self-Seal Sterilization Pouch and Roll
K251177 · Guangdong Maidi Medical Co., Ltd. · Dec 2025
Chex-All Sterilization Pouches and Tubes
K250306 · Propper Manufacturing Co., Inc. · Oct 2025
Sterilization Pouch and Roll
K243179 · Yichang Xinxin Paper Products Co., Ltd. · Jun 2025
GCI Sterilization Wrappers
K250321 · George Courey, Inc. · Jun 2025
Self Sealing Sterilization Pouches
K243721 · Wellmed Dental Medical Supply Co., Ltd. · Apr 2025