FDA product code OXZ: Pediatric/Child Facemask
OXZ is the FDA product code for pediatric/child facemask. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 9 510(k) submissions under OXZ, 3 in the last five years, from 8 different applicants. The average 510(k) review took 353 days (median 335).
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.
Classification
| Field | Value |
|---|---|
| Device name | Pediatric/Child Facemask |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OXZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 217 |
| 2021 | 2 | 412 |
| 2022 | 2 | 408 |
| 2023 | 1 | 553 |
Compare with all 510(k) review times · Search every OXZ clearance
Top OXZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kimberly-Clark | 2 | 2012-05-04 |
| Xinxiang Kangbeier Medical Technology Co., Ltd. | 1 | 2023-12-21 |
| Primed Medical Products, Inc. | 1 | 2022-11-22 |
| Dukal Corporation | 1 | 2022-03-29 |
| Shandong Shengquan New Material Co., Ltd. | 1 | 2021-10-10 |
3 more applicants have OXZ clearances. See the full list in Caduvo.
Most recent OXZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221753 | Xinxiang Kangbeier Medical Technology Co., Ltd. | Kangbeier Child Surgical Mask | 2023-12-21 | 553 |
| K213427 | Primed Medical Products, Inc. | PRIMED Pediatric Facemask | 2022-11-22 | 397 |
| K210321 | Dukal Corporation | Dukal Corporation Level 1 Pediatric Face Mask | 2022-03-29 | 418 |
| K201514 | Shandong Shengquan New Material Co., Ltd. | Child Face Mask | 2021-10-10 | 489 |
| K202831 | Pac-Dent, Inc. | The iMask Child's Face Mask | 2021-08-26 | 335 |
Recalls for OXZ devices
openFDA lists no recalls for product code OXZ.
Frequently asked questions
What is FDA product code OXZ?
OXZ is the FDA product code for pediatric/child facemask. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is OXZ?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXZ?
Across 9 cleared submissions the average was 353 days from receipt to decision (median 335).
Which companies have the most OXZ clearances?
Kimberly-Clark (2); Xinxiang Kangbeier Medical Technology Co., Ltd. (1); Primed Medical Products, Inc. (1); Dukal Corporation (1); Shandong Shengquan New Material Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OXZ
- Run a recall and safety report across every OXZ manufacturer
- Watch product code OXZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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