Regard™
Gown Iso Pullover AAMI 4 UNIV 40gsm
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Wonderful Nonwoven Technology Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 7 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Hubei Xinxin NON-Woven Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 10 |
Record
| Listed by | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | QPC |
| Device type | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| 510(k) | K222128 |
| Record published | 2024-11-28 |
| Record revised | 2026-05-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A4ISOPULNS-REG | 10 | In distribution | |
| A4ISOP2XLNS-REG | 6 | In distribution | |
| A4ISOPXLNS-REG | 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Medline | Medline Industries, Inc. | 3 |
| ProtectX | The Azac Group | 2 |
| Encompass | Encompass Group, L.L.C. | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.