PRIMED Pediatric Facemask
FDA 510(k) K213427 · Primed Medical Products, Inc.
510(k) numberK213427
Submission
- Device name
- PRIMED Pediatric Facemask
- Applicant
- Primed Medical Products, Inc.
Edmonton, CA - Received
- October 21, 2021
- Decision date
- November 22, 2022
- 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 |
| 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 |
| K113340 | Kimberly-Clark Child's FacemaskOXZ · Traditional | Kimberly-Clark | 05/04/2012SE |
| K103150 | Kimberly-Clark Child/Pediatric Face MaskOXZ · Traditional | Kimberly-Clark | 09/23/2011SE |
More from Kimberly-Clark
| 510(k) | Device | Decision |
|---|---|---|
| K262007 | PRIMED AAMI Level 3 Open Back GownsQPC · Traditional | 09/11/2026SE |
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…QSO · Traditional | 09/01/2026SE |
| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | 11/04/2025SE |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 10/07/2024SE |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure MasksFXX · Traditional | 08/26/2024SE |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 05/24/2024SE |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3)FYC · Traditional | 11/04/2016SE |
| K092012 | Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model…FXX · Special | 09/25/2009SE |
| K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksFXX · Special | 08/11/2008SE |
Questions and answers
When was PRIMED Pediatric Facemask cleared by the FDA?
PRIMED Pediatric Facemask (K213427) received a 510(k) decision of Substantially Equivalent on November 22, 2022, 397 days after the submission was received.
What is the product code of K213427?
The FDA product code is OXZ – Pediatric/Child Facemask, a Class II (moderate risk) device regulated under 21 CFR 878.4040.