Perpak Sterilization Tyvek Pouch
by Km Corp.
510(k) K241123
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241123 | Date18 Sep 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Perpak Sterilization Tyvek Pouch is a sterile barrier system classified as a Wrap, Sterilization device (product code FRG). It is designed to protect medical devices from contamination during sterilization and storage, ensuring microbial integrity through Tyvek® material and reinforced plastic film. The pouch provides resistance to microbial penetration while maintaining puncture and tear strength, suitable for various sterilization methods. Its construction adheres to international medical packaging standards, ensuring reliability for sterile processing applications.
This pouch is supplied as a single-use item, intended for use in hospital or clinical sterile processing environments. It is not reusable and must be discarded after one use to maintain sterility. The device is FDA-cleared under 510(k) number K241123, with a traditional review pathway and classification as Class II under Special Controls. Storage should follow manufacturer guidelines to preserve barrier integrity, and compatibility with standard sterilization techniques (e.g., ethylene oxide, steam) is implied by its design specifications.
Other devices from Km Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Perpak Sterilization Tyvek Pouch designed for?
The Perpak Sterilization Tyvek Pouch is a sterile barrier system specifically designed to protect medical devices from contamination during sterilization and storage. Its Tyvek® material and reinforced plastic film create a reliable barrier against microbial penetration while maintaining puncture and tear resistance. This ensures the devices remain sterile throughout the sterilization process and during subsequent storage, adhering to international medical packaging standards.
Is the Perpak Sterilization Tyvek Pouch reusable or single-use?
The Perpak Sterilization Tyvek Pouch is intended for single-use only. After one use, it must be discarded to maintain sterility and prevent cross-contamination. This design aligns with best practices in sterile processing environments, where single-use pouches are preferred to uphold microbial integrity and regulatory compliance.
What sterilization methods is this pouch compatible with?
The pouch is designed to be compatible with standard sterilization methods, including ethylene oxide and steam sterilization. Its construction—Tyvek® material combined with reinforced plastic film—ensures resistance to microbial penetration and maintains barrier integrity under these processes. Always follow the manufacturer’s guidelines for optimal performance and safety.
How should the Perpak Sterilization Tyvek Pouch be stored?
Storage of the Perpak Sterilization Tyvek Pouch should follow the manufacturer’s instructions to preserve its barrier integrity. Proper storage conditions help prevent damage to the pouch, ensuring it remains effective for its intended single-use application. Avoid exposure to moisture, extreme temperatures, or physical stress that could compromise the Tyvek® material or reinforced film.
What regulatory approval does the Perpak Sterilization Tyvek Pouch hold?
The Perpak Sterilization Tyvek Pouch is FDA-cleared under 510(k) number K241123, following a traditional review pathway. It is classified as a Class II device under Special Controls and is intended for use in hospital or clinical sterile processing environments. The clearance confirms its compliance with U.S. regulatory standards for sterile barrier systems.