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Sterilization Pouch and Roll

by Yichang Xinxin Paper Products Co., Ltd.

510(k) K243179

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243179 Date26 Jun 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sterilization Pouch and Roll is a sterilization wrap, classified under product code FRG and regulated under 21 CFR 880.6850. This device is designed to encase and protect medical instruments, supplies, or devices during sterilization processes, ensuring sterility and barrier integrity for subsequent use in clinical settings. Constructed as a rollable pouch, it provides a convenient and scalable solution for hospitals and healthcare facilities requiring bulk sterilization packaging.

This device is supplied in a reusable or single-use format, depending on the specific pouch design, and is intended for use in hospital environments as indicated by the General Hospital advisory committee review. It must be handled in accordance with sterilization protocols to maintain barrier integrity and prevent contamination. The Sterilization Pouch and Roll received FDA 510(k) clearance under K243179, confirming its substantial equivalence to a predicate device. Storage conditions and sterility validation should adhere to manufacturer guidelines to ensure proper functionality and compliance.