K252940
- 510(k) number
- K252940
- Device name
- VR® Personal Protective Level 3 Gown (VR Gowns)
- Applicant
- PolyConversions, Inc. IL · US
- Product code
- QPC — Gown, Non-Sterile, Non-Isolation, Intended To Provid
- Decision date
- 2025-12-16
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K252940
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.