Gown Poly Reinforced Large(product No.900-522)/(reorder No. 0522)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K971920 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 Gown Poly Reinforced Large is a surgeon's gown designed as protective apparel for operating room personnel. It is worn during surgical procedures to act as a barrier against the transfer of microorganisms, body fluids, and particulate material, providing protection for both the patient and healthcare personnel.
This device is intended for use in clinical and surgical settings. It has received FDA 510(k) clearance under K971920 and is classified as a class 2 medical device.
Frequently asked questions
What is the primary purpose of the Gown Poly Reinforced Large?
This gown is designed as protective apparel for operating room personnel. It functions as a barrier to prevent the transfer of microorganisms, body fluids, and particulate material between the patient and healthcare staff during surgical procedures.
In what settings is this surgical gown intended to be used?
The device is intended for use in clinical and surgical settings where protective apparel is required to maintain a barrier against contaminants during medical operations.
What is the regulatory status of this gown?
The Gown Poly Reinforced Large is classified as a class 2 medical device and has received FDA 510(k) clearance under K971920, confirming it is substantially equivalent to existing devices.
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: Gown Poly Reinforced Large (Product No.900-522)/ (Reorder No. 0522), Gown Poly Reinforced Large (Product No.900-522)/ (Reorder No. 0522), GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDE… - FDA.report, Customed, Inc. FDA 510 (k) Products (1990-1998)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971920 | Class II | Active |
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Manufacturer
- Manufacturer
- Customed, Inc.
Sources (1)
- FDA 510(k) K971920 24 fields · synced Oct 6, 2026