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FDA 510(k)

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

K-Number: K153540 · 2016-08-04

ApplicantSafe Secure Packaging Co., Ltd.
Decision Date2016-08-04
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is a medical device manufactured by Safe Secure Packaging Co., Ltd.. It received FDA 510(k) clearance on 2016-08-04 under approval number K153540. 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 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is a medical device that received FDA 510(k) clearance on 2016-08-04. It is manufactured by Safe Secure Packaging Co., Ltd.. The 510(k) number is K153540.

When was Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators approved by the FDA?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators received FDA 510(k) clearance on 2016-08-04, under approval number K153540.

What company makes Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is manufactured by Safe Secure Packaging Co., Ltd..

What is the FDA product code for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

The FDA product code for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is FRG.

Related Clinical Trials

NCT06832163 Close Loop Smart Weaning for INO With PPHN RECRUITING NCT07530328 Clinical Evaluation of Copesilcup COMPLETED

Related PubMed Literature

PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025)

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. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc. K152458Gemini Bonded Sterilization WrapMedline Industries, Inc.

Official Source

View on FDA Database →

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

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