Kangbeier Child Surgical Mask
FDA 510(k) clearance K221753 · decided 2023-12-21
Clearance details
- K-number
- K221753
- Device name
- Kangbeier Child Surgical Mask
- Applicant
- Xinxiang Kangbeier Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-16
- Decision date
- 2023-12-21
- Days to decision
- 553 days
- Clearance type
- Traditional
- Product code
- OXZ
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Changyuan, CN
- Third-party review
- No
- Expedited review
- No
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| Prestige Ameritech Pediatric/Child’s Face mask (K160100) | Prestige Ameritech | 2016-10-07 |
| KIMBERLY-CLARK CHILD'S FACEMASK (K113340) | Kimberly-Clark | 2012-05-04 |
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Recalls involving this device
No recalls on record reference this clearance.