OXZ
9 FDA 510(k) clearances · Product code
335 daysmedian time to decision
553 days90th percentile
9clearances measured
FDA profile
- Official device name
- Pediatric/Child Facemask
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- FDA definition
- A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Kangbeier Child Surgical Mask (K221753) | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023-12-21 |
| PRIMED Pediatric Facemask (K213427) | Primed Medical Products, Inc. | 2022-11-22 |
| Dukal Corporation Level 1 Pediatric Face Mask (K210321) | Dukal Corporation | 2022-03-29 |
| Child Face Mask (K201514) | Shandong Shengquan New Material Co., Ltd. | 2021-10-10 |
| The iMask Child's Face Mask (K202831) | Pac-Dent, Inc. | 2021-08-26 |
| 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) (K190308) | Amd Medicom, Inc. | 2019-09-17 |
| Prestige Ameritech Pediatric/Child’s Face mask (K160100) | Prestige Ameritech | 2016-10-07 |
| KIMBERLY-CLARK CHILD'S FACEMASK (K113340) | Kimberly-Clark | 2012-05-04 |
| KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK (K103150) | Kimberly-Clark | 2011-09-23 |
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Every clearance here is in the API, with alerts when new ones post.