Data / Medical devices / Pediatric/Child Facemask
Pediatric/Child Facemask (OXZ): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Pediatric/Child Facemask (product code OXZ, Class 2, 21 CFR 878.4040). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on December 21, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OXZ
- Device class
- 2
- Regulation
- 878.4040
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| Canada | 4 |
| United States | 3 |
| China | 3 |
| Mexico | 1 |
| Laos | 1 |
Makers of Pediatric/Child Facemask
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| La Ada de Acuna | CIUDAD DE ACUNA Coahuila, Mexico | Manufacturer | 2 | May 4, 2012 | 0 | 0 | 0 | api.fda.gov |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | May 4, 2012 | 0 | 0 | 0 | api.fda.gov |
| Amd Medicom Inc. | Saint-Laurent Quebec, Canada | Complaint file establishment, Manufacturer | 1 | September 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Specification developer | 1 | September 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Prestige Ameritech | North Richland Hills, TX, United States | Contract manufacturer, Manufacturer | 1 | October 7, 2016 | 0 | 0 | 0 | api.fda.gov |
| Primed Medical Products Inc. | Edmonton Alberta, Canada | Specification developer | 1 | November 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Meiguan Care Products Technology Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRIMED Laos Medical Products Manufacturing Sole Co., Ltd. | Vientiane Capital Viangchan(Prefecture), Laos | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRIMED Medical Products Manufacturing Ltd. | Cambridge Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Medical Enterprise, Inc. | Thomson, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Jiayin Sanitary Products Co., Ltd. | Zhangjiagang City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.