ProGear
Imprints™ Earloop Economy (USA)
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Jiangsu. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Zhangjiagang Jiayin Sanitary Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 3 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
Record
| Listed by | Prestige Ameritech, United States |
|---|---|
| FDA product code | OXZ |
| Device type | Pediatric/Child Facemask |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-26 |
| Record revised | 2026-06-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FM85011-CCM1 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Primed | Primed Medical Products Inc. | 9 |
| Halyard | O&M Halyard, Inc. | 4 |
| Vivit Supply | Vivit Supply LLC | 3 |
| Medicom SafeMask | AMD Medicom Inc. | 2 |
| ProKids | Prestige Ameritech | 2 |
| American Kid Disposable Face Maks | Armbrust Inc. | 1 |
| Medicom Safemask Premier | AMD Medicom Inc. | 1 |
| Instagard | Cardinal Health 200, LLC | 1 |
| Medicom AssureMask | AMD Medicom Inc. | 1 |
| McKesson | Mckesson Medical-Surgical Inc. | 1 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160100 | 2016-10-07 |
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.