← Back to catalogue

BH Sterilization Pouch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172280

by Bh Medical Products Co., Ltd.

Identifiers

510(k) Number
K172280 FDA 510(k)
FDA Product Code
FRG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BH Sterilization Pouch is a sterilization wrap, classified under 21 CFR 880.6850, designed to safely enclose medical devices for steam sterilization in autoclaves. It provides a barrier to protect instruments and reduce contamination risk during the sterilization process, ensuring sterility for subsequent use in clinical settings.

This pouch is intended for single-use in dental and general hospital environments, adhering to pre-vacuum steam sterilization cycles at 132°C for 4 minutes. Supplied sterile, it is regulated under FDA 510(k) clearance (K172280) and manufactured by Bh Medical Products Co., Ltd. in Changzhou, China. Compliance with 21 CFR 880.6850 ensures its suitability for sterile barrier applications in regulated healthcare settings.

Frequently asked questions

What types of medical devices can be safely enclosed in the BH Sterilization Pouch for steam sterilization?

The BH Sterilization Pouch is designed to safely enclose medical devices intended for dental and general hospital use during pre-vacuum steam sterilization cycles at 132°C for 4 minutes. It acts as a protective barrier to minimize contamination risk during sterilization, ensuring the enclosed items remain sterile for subsequent clinical use.

Is the BH Sterilization Pouch intended for reuse, or is it meant to be used only once?

The BH Sterilization Pouch is explicitly labeled for single-use only. After sterilization, it should not be reused to maintain sterility and reduce contamination risks in clinical settings.

How should the BH Sterilization Pouch be stored before use, and is it supplied in a sterile condition?

The BH Sterilization Pouch is supplied sterile and should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures its integrity and sterility until use.

What is the regulatory pathway for the BH Sterilization Pouch, and how was its equivalence determined?

The BH Sterilization Pouch follows the FDA 510(k) clearance process under Traditional Review, with a decision code of SESE (Substantially Equivalent, Same Essential Features). Its equivalence was determined through a review by the General Hospital (HO) Advisory Committee, confirming it meets regulatory standards for sterilization wraps under 21 CFR 880.6850.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BH Sterilization Pouch (K172280) - FDA 510 (k), BH Sterilization Pouch by BH Medical Products Co., Ltd. | FDA 510 (k ..., BH Medical Products Co., Ltd. - Made-in-China.com, BH Sterilization Pouch (K172280) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bh Medical Products Co., Ltd.

Sources (1)

  • FDA 510(k) K172280 24 fields · synced Sep 18, 2026