FDA 510(k)

Sterilization Wrap

K-Number: K222151 · 2023-03-23

Decision Date2023-03-23

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sterilization Wrap is a medical device manufactured by Kenpax International Limited. It received FDA 510(k) clearance on 2023-03-23 under approval number K222151. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterilization Wrap?

Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Kenpax International Limited. The 510(k) number is K222151.

When was Sterilization Wrap approved by the FDA?

Sterilization Wrap received FDA 510(k) clearance on 2023-03-23, under approval number K222151.

What company makes Sterilization Wrap?

Sterilization Wrap is manufactured by Kenpax International Limited.

What is the FDA product code for Sterilization Wrap?

The FDA product code for Sterilization Wrap is FRG.

Other Devices by Kenpax International Limited

K212504Isolation Gown AAMI Level 3 K202899Procedure Mask, Surgical Mask K222128Protective Gown AAMI Level 4

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.