K261115
- 510(k) number
- K261115
- Device name
- VR® Personal Protective Level 4 Gown (VR Gowns)
- Applicant
- PolyConversions, Inc. IL · US
- Product code
- QPC — Gown, Non-Sterile, Non-Isolation, Intended To Provid
- Decision date
- 2026-08-11
- Date received
- 2026-04-03
- 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: K261115
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.