Anaerobic Box Glove
Anaerobic Box Glove is a component of an anaerobic workstation or glove box, designed to allow laboratory personnel to handle specimens and perform microbiological procedures in an oxygen-free environment necessary for the cultivation and identification of anaerobic organisms. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JTM, regulated under 21 CFR 866.2120, and falls within the Microbiology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- JTM
- Device Class
- FDA class 1
- Regulation Number
- 866.2120
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K800430 | OXIDE ANAEROBIC SYSTEM | Apr 02, 1980 | Substantially Equivalent | Oxoid U.S.A., Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.