FDA product code JTM: Anaerobic Box Glove
JTM is the FDA product code for anaerobic box glove. It is a Class I device, regulated under 21 CFR 866.2120 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under JTM. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Anaerobic Box Glove |
| Device class | Class I |
| Regulation | 21 CFR 866.2120 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JTM clearance
Top JTM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oxoid U.S.A., Inc. | 1 | 1980-04-02 |
Most recent JTM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K800430 | Oxoid U.S.A., Inc. | OXIDE ANAEROBIC SYSTEM | 1980-04-02 | 36 |
Recalls for JTM devices
openFDA lists no recalls for product code JTM.
Frequently asked questions
What is FDA product code JTM?
JTM is the FDA product code for anaerobic box glove. It is a Class I device, regulated under 21 CFR 866.2120 and reviewed by the Microbiology panel.
What device class is JTM?
Class I, regulation 21 CFR 866.2120. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTM?
Across 1 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most JTM clearances?
Oxoid U.S.A., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JTM
- Run a recall and safety report across every JTM manufacturer
- Watch product code JTM 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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