510(k) K201514
- Device
- Child Face Mask
- Applicant
- Shandong Shengquan New Material Co., Ltd.
- 510(k) number
- K201514
- Product code
- OXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-10-10
- Date received
- 2020-06-08
- Regulation
- 878.4040
- Classification name
- Pediatric/child Facemask
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Xiumei Zhang
- Address
- Diaozhen Industrial Development Zone, Zhangqiu District Jinan CN 250204 250204
FDA Registration Numbers#
- 3013152643
- 3012421607
- 3017425988
- 3011390041
- 3005022483
- 3014421917
- 9616096
- 3017229009
- 9611959
- 3017949824
- 3005599545
- 9615270
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OXZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221753 | Kangbeier Child Surgical Mask | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023-12-21 |
| K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022-11-22 |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022-03-29 |
| 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/Child’s 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 |
Legacy Summary#
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FDA Review#
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