← FDA Medical Device Classifications
Patient Examination Glove
FMC · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6250
Classification
- FDA Product Code
FMC- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 880.6250
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 34
- Registered establishments
- 11
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown