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FDA 510(k)

Chex-All Sterilization Pouches and Tubes

K-Number: K250306 · 2025-10-31

ApplicantPropper Manufacturing Co., Inc.
Decision Date2025-10-31
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Chex-All Sterilization Pouches and Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Propper Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K250306. 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 Chex-All Sterilization Pouches and Tubes?

Chex-All Sterilization Pouches and Tubes is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Propper Manufacturing Co., Inc.. The 510(k) number is K250306.

When did Chex-All Sterilization Pouches and Tubes receive FDA 510(k) clearance?

Chex-All Sterilization Pouches and Tubes received FDA 510(k) clearance on 2025-10-31, under 510(k) number K250306.

Who is the listed applicant for Chex-All Sterilization Pouches and Tubes?

The FDA 510(k) record lists Propper Manufacturing Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chex-All Sterilization Pouches and Tubes?

The FDA product code for Chex-All Sterilization Pouches and Tubes is FRG.

Other records listing Propper Manufacturing Co., Inc. 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.

K240910EO Chex Indicator TapeK222137OK Plus IndicatorK212592Gas-Chex IndicatorK210866Steri-Dot Process IndicatorK210553Steam-Dot Process Indicator

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.K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.

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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