FDA Product Code
FDA Product Code OXZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221753 | Kangbeier Child Surgical Mask | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023-12-21 | Traditional | PDF ↗ |
| K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022-03-29 | Traditional | PDF ↗ |
| K201514 | Child Face Mask | Shandong Shengquan New Material Co., Ltd. | 2021-10-10 | Traditional | PDF ↗ |
| K202831 | The iMask Child's Face Mask | Pac-Dent, Inc. | 2021-08-26 | Traditional | PDF ↗ |
| K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) | Amd Medicom, Inc. | 2019-09-17 | Traditional | PDF ↗ |
| K160100 | Prestige Ameritech Pediatric/Childs Face mask | Prestige Ameritech | 2016-10-07 | Traditional | PDF ↗ |
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | Kimberly-Clark | 2012-05-04 | Traditional | PDF ↗ |
| K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | Kimberly-Clark | 2011-09-23 | Traditional | PDF ↗ |
Product code OXZ · Class II · General, Plastic Surgery. Data: openFDA.