Identifiers
- 510(k) Number
- K222403 FDA 510(k)
- FDA Product Code
- FYA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Surgical Gown is a disposable medical device designed to provide barrier protection for healthcare professionals during surgical procedures. It is intended to protect the patient and the wearer from the transfer of microorganisms, body fluids, and other potentially infectious materials.
The device is supplied sterile and is intended for single-use only. It is not MRI safe and should be stored in a dry, cool place away from direct sunlight. The device has received FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.
Frequently asked questions
What is the primary function of this Surgical Gown?
The Surgical Gown is designed to provide barrier protection for healthcare professionals during surgical procedures. It protects both the wearer and the patient from the transfer of microorganisms, body fluids, and other potentially infectious materials.
Is this product sterile and intended for single use?
Yes, the device is supplied sterile and is intended for single-use only. This ensures that the barrier protection remains effective and reduces the risk of cross-contamination.
How should the Surgical Gown be stored?
The device should be stored in a dry, cool place away from direct sunlight to maintain its integrity and sterility before use.
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: Guangzhou Fuzelong Hygiene Material Co., Ltd, Company Overview - Guangzhou Fuzelong Hygiene Material Co., Ltd., Featured products from Guangzhou Fuzelong Hygiene Material Co., Ltd ..., Guangzhou Fuzelong Hygiene Material Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222403 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Fuzelong Hygiene Material Co., Ltd.
Sources (1)
- FDA 510(k) K222403 24 fields · synced Oct 6, 2026