Sterilization Wrap

FDA 510(k) K222151 · Kenpax International Limited

Substantially Equivalent

510(k) numberK222151

Submission

Device name
Sterilization Wrap
Applicant
Kenpax International Limited
Hong Kong, CN
Received
July 20, 2022
Decision date
March 23, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRG – Wrap, Sterilization
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6850
Specialty
General Hospital

Other 510(k)s with product code FRG

510(k)DeviceApplicantDecision
K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional O&M Halyard, Inc.07/02/2026SE
K252823Dukal Crepe Paper Sterilization WrapFRG · Traditional Dukal, LLC05/28/2026SE
K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional O&M Halyard, Inc.05/18/2026SE
K251347Sterilization Pouch/RollFRG · Traditional Sterivic Medical Co., Ltd.01/28/2026SE
K251177Self-Seal Sterilization Pouch and RollFRG · Traditional Guangdong Maidi Medical Co., Ltd.12/12/2025SE
K250306Chex-All Sterilization Pouches and TubesFRG · Abbreviated Propper Manufacturing Co., Inc.10/31/2025SE
K243179Sterilization Pouch and RollFRG · Traditional Yichang Xinxin Paper Products Co., Ltd.06/26/2025SE
K250321GCI Sterilization WrappersFRG · Traditional George Courey, Inc.06/06/2025SE
K243721Self Sealing Sterilization PouchesFRG · Traditional Wellmed Dental Medical Supply Co., Ltd.04/25/2025SE
K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional Turbett Surgical04/04/2025SE

More from Turbett Surgical

510(k)DeviceDecision
K222128Protective Gown AAMI Level 4QPC · Traditional 08/08/2023SE
K212504Isolation Gown AAMI Level 3FYC · Traditional 11/07/2021SE
K202899Procedure Mask, Surgical MaskFXX · Traditional 05/20/2021SE

Questions and answers

When was Sterilization Wrap cleared by the FDA?

Sterilization Wrap (K222151) received a 510(k) decision of Substantially Equivalent on March 23, 2023, 246 days after the submission was received.

What is the product code of K222151?

The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.