Pediatric/Child Facemask
The Pediatric/Child Facemask is a single-use, disposable surgical facemask intended to be worn by pediatric patients to provide protection for the respiratory tract in a healthcare setting with appropriate adult supervision. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OXZ, with regulation number 878.4040 under the General, Plastic Surgery medical specialty.
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Basic Information
- Product Code
- OXZ
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221753 | Kangbeier Child Surgical Mask | Dec 21, 2023 | Substantially Equivalent | Xinxiang Kangbeier Medical Technology Co., Ltd. |
| K213427 | PRIMED Pediatric Facemask | Nov 22, 2022 | Substantially Equivalent | Primed Medical Products, Inc. |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Mar 29, 2022 | Substantially Equivalent | Dukal Corporation |
| K201514 | Child Face Mask | Oct 10, 2021 | Substantially Equivalent | Shandong Shengquan New Material Co., Ltd. |
| K202831 | The iMask Child's Face Mask | Aug 26, 2021 | Substantially Equivalent | Pac-Dent, Inc. |
| 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) | Sep 17, 2019 | Substantially Equivalent | Amd Medicom, Inc. |
| K160100 | Prestige Ameritech Pediatric/Childs Face mask | Oct 07, 2016 | Substantially Equivalent | Prestige Ameritech |
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | May 04, 2012 | Substantially Equivalent | Kimberly-Clark |
| K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | Sep 23, 2011 | Substantially Equivalent | Kimberly-Clark |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.