JTMClass I
Anaerobic Box Glove
21 CFR 866.2120 / Microbiology
JTM is the FDA product code for Anaerobic Box Glove, a class I device type, regulated under 21 CFR 866.2120. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JTM
- Device name
- Anaerobic Box Glove
- Regulation
- 21 CFR 866.2120
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code JTM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
Applicants with the most clearances
Product code JTM| Applicant | Clearances |
|---|---|
| Oxoid U.S.A., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Anaerobe Systems
- Bestreat Safety & First Aid Solution Co., Ltd
- Cohesion Health International Co., Ltd
- Comatrix Technology Vietnam Company Limited
- Gauke (Hubei) Healthcare Co., Ltd
- Gauke International Trading Co., Ltd.
- Greens Surgicals Private Limited
- Hager Worldwide, Inc.
- Jinhua Jingdi Medical Supplies Co.,Ltd
- K&R Technologies dba Microbiology International
- Ningbo Tianbo First Aid Product Co., Ltd.
- Shanghai Joy Crown Industry Co., Ltd
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
