510(k) clearance
PRIMED AAMI Level 3 Open Back Gowns
- 510(k) number
- K262007
- Applicant
- PRIMED Medical Products, Inc.
- Decision date
- Sep 11, 2026
- Date received
- Jun 15, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QPC
- Device type
- Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- Device class
- Class II
- Regulation
- 21 CFR 878.4040
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Edmonton, CA