ProtectX
Aami Level 3 Disposable Protective Gown Over THE Head With Thumb Loop Nonsterile Extra Large Yellow
3manufacturers in China registered for this device type
2catalogue 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 | The Azac Group |
|---|---|
| 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) | K211538 |
| Record published | 2022-04-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Packaging | Plastic bag of 2, box of 8, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| LTF-0218-25-B | 10 | In distribution | |
| LTF-0218-25 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 3 |
| Medline | Medline Industries, Inc. | 3 |
| 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.