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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. It received FDA 510(k) clearance on 2024-10-16 under 510(k) 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. The listed applicant is Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. The 510(k) number is K242839.

When did Safe Secure Sterilization Pouches and Rolls receive FDA 510(k) clearance?

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

Who is the listed applicant for Safe Secure Sterilization Pouches and Rolls?

The FDA 510(k) record lists Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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