510(k) clearance
Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
- 510(k) number
- K260407
- Applicant
- Principle & Will Co., Ltd.
- Decision date
- Aug 26, 2026
- Date received
- Feb 9, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FYA
- Device type
- Gown, Surgical
- Device class
- Class II
- Regulation
- 21 CFR 878.4040
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Statement
- Third party
- N
- Location
- Apia, WS