← FDA Medical Device Classifications
Non-Surgical Gown
OEA · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4040
Classification
- FDA Product Code
OEA- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 878.4040
- Review panel
- HO
- Medical specialty
- General, Plastic Surgery
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 542
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown