510(k) K221753
- Device
- Kangbeier Child Surgical Mask
- Applicant
- Xinxiang Kangbeier Medical Technology Co., Ltd.
- 510(k) number
- K221753
- Product code
- OXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-21
- Date received
- 2022-06-16
- Regulation
- 878.4040
- Classification name
- Pediatric/Child Facemask
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Shaoju Tian
- Address
- East Mancun Industrial District Changyuan CN 453400 453400
FDA Registration Numbers
- 3013152643
- 3012421607
- 3017425988
- 3011390041
- 3005022483
- 3014421917
- 9616096
- 3017229009
- 9611959
- 3017949824
- 3005599545
- 9615270
Source Documents
Other 510(k) Records For Product Code OXZ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022-11-22 |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022-03-29 |
| K201514 | Child Face Mask | Shandong Shengquan New Material Co., Ltd. | 2021-10-10 |
| K202831 | The iMask Child's Face Mask | Pac-Dent, Inc. | 2021-08-26 |
| 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 |
| K160100 | Prestige Ameritech Pediatric/Childs Face mask | Prestige Ameritech | 2016-10-07 |
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | Kimberly-Clark | 2012-05-04 |
| K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | Kimberly-Clark | 2011-09-23 |