Kimberly-Clark Child's Facemask
FDA 510(k) K113340 · Kimberly-Clark
510(k) numberK113340
Submission
- Device name
- Kimberly-Clark Child's Facemask
- Applicant
- Kimberly-Clark
Roswell, GA, US - Received
- November 14, 2011
- Decision date
- May 4, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OXZ – Pediatric/Child Facemask
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code OXZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221753 | Kangbeier Child Surgical MaskOXZ · Traditional | Xinxiang Kangbeier Medical Technology Co., Ltd. | 12/21/2023SE |
| K213427 | PRIMED Pediatric FacemaskOXZ · Traditional | Primed Medical Products, Inc. | 11/22/2022SE |
| K210321 | Dukal Corporation Level 1 Pediatric Face MaskOXZ · Traditional | Dukal Corporation | 03/29/2022SE |
| K201514 | Child Face MaskOXZ · Traditional | Shandong Shengquan New Material Co., Ltd. | 10/10/2021SE |
| K202831 | The iMask Child's Face MaskOXZ · Traditional | Pac-Dent, Inc. | 08/26/2021SE |
| K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom…OXZ · Traditional | Amd Medicom, Inc. | 09/17/2019SE |
| K160100 | Prestige Ameritech Pediatric/Childs Face maskOXZ · Traditional | Prestige Ameritech | 10/07/2016SE |
| K103150 | Kimberly-Clark Child/Pediatric Face MaskOXZ · Traditional | Kimberly-Clark | 09/23/2011SE |
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Questions and answers
When was Kimberly-Clark Child's Facemask cleared by the FDA?
Kimberly-Clark Child's Facemask (K113340) received a 510(k) decision of Substantially Equivalent on May 4, 2012, 172 days after the submission was received.
What is the product code of K113340?
The FDA product code is OXZ – Pediatric/Child Facemask, a Class II (moderate risk) device regulated under 21 CFR 878.4040.