Encompass
Valuecare ISO Gown, XL, 100EA TS Valuecare ISO Gown, OH Apron, Thumbloop, Blue PE Plastic
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 | Encompass Group, 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 |
| Premarket notification | Exempt |
| Record published | 2023-06-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VA550-25XB | In distribution | |
| VA550-25 | 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 |
| ProtectX | The Azac Group | 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.