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)
FDA 510(k) clearance K190308 · decided 2019-09-17
Clearance details
- K-number
- K190308
- Device name
- 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)
- Applicant
- Amd Medicom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-12
- Decision date
- 2019-09-17
- Days to decision
- 217 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
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.