FDA product code NZJ: Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
NZJ is the FDA product code for respirator, n95, for use by the general public in public health medical emergencies. It is a Class II device, regulated under 21 CFR 880.6260 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under NZJ. The average 510(k) review took 87 days (median 87). 1 De Novo request was granted under it. FDA has posted 2 recalls for NZJ devices.
Definition
It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.
Classification
| Field | Value |
|---|---|
| Device name | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies |
| Device class | Class II |
| Regulation | 21 CFR 880.6260 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NZJ clearance
Top NZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pasture Pharma Pte, Ltd. | 1 | 2009-01-23 |
Most recent NZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083176 | Pasture Pharma Pte, Ltd. | PASTURE, MODELS: F550, A520 | 2009-01-23 | 87 |
Recalls for NZJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-07-27.
| Year | Recalls |
|---|---|
| 2020 | 2 |
Frequently asked questions
What is FDA product code NZJ?
NZJ is the FDA product code for respirator, n95, for use by the general public in public health medical emergencies. It is a Class II device, regulated under 21 CFR 880.6260 and reviewed by the General Hospital panel.
What device class is NZJ?
Class II, regulation 21 CFR 880.6260. Typical premarket route: 510(k).
How long does a 510(k) take for product code NZJ?
Across 1 cleared submissions the average was 87 days from receipt to decision (median 87).
Which companies have the most NZJ clearances?
Pasture Pharma Pte, Ltd. (1).
Have NZJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code NZJ
- Run a recall and safety report across every NZJ manufacturer
- Watch product code NZJ 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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