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FDA 510(k)

Safe Secure Sterilization Pouches and Rolls

K-Number: K242839 · 2024-10-16

ApplicantShenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
Decision Date2024-10-16
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safe Secure Sterilization Pouches and Rolls is a medical device manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. It received FDA 510(k) clearance on 2024-10-16 under approval number K242839. 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 Pouches and Rolls?

Safe Secure Sterilization Pouches and Rolls is a medical device that received FDA 510(k) clearance on 2024-10-16. It is manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. The 510(k) number is K242839.

When was Safe Secure Sterilization Pouches and Rolls approved by the FDA?

Safe Secure Sterilization Pouches and Rolls received FDA 510(k) clearance on 2024-10-16, under approval number K242839.

What company makes Safe Secure Sterilization Pouches and Rolls?

Safe Secure Sterilization Pouches and Rolls is manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd..

What is the FDA product code for Safe Secure Sterilization Pouches and Rolls?

The FDA product code for Safe Secure Sterilization Pouches and Rolls is FRG.

Other Devices by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

K213358Surgical Mask K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)

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

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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