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) K260407
Substantially EquivalentPrinciple & Will Co., Ltd.
FDA 510(k) clearance K260407 for 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, Substantially Equivalent on 2026-08-26. Applicant: Principle & Will Co., Ltd.. Device class: 2.
Summary
Principle & Will's device name lists sterile and non-sterile Level 3 surgical gowns (reinforced) and Level 4 surgical gowns/isolation gowns, citing ANSI/AAMI PB 70. The product code is FYA, surgical gowns.
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
The record lists the applicant location as Apia, Samoa. The decision came 198 calendar days after receipt (February 9 to August 26, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Principle & Will Co., Ltd.
- Product code
- Product code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Apia, WS
Recent devices under product code FYA
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