# K260407: 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

- Pathway: 510(k) (Traditional)
- Applicant: Principle & Will Co., Ltd.
- Decided: Aug 26, 2026 after 198 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Level 3: "The Principle & Will ANSI/AAMI PB 70 Sterile Level 3 Surgical Gown (Reinforced) is a sterile, single-use surgical apparel intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate matter. The non-sterile Level 3 Surgical Gown (Reinforced) is intended for distribution to re-packager/re-labeler or sterilizer establishments for sterilization using a validated ethylene oxide sterilization method in accordance with ISO 11135 prior to marketing to end users." The Principle & Will ANSI/AAMI PB 70 Sterile/Non-sterile Level 3 Surgical Gowns (Reinforced) meet the ANSI/AAMI PB70 Level 3 liquid barrier performance requirements, as well as the other performance requirements of ASTM F2407_F2407M-23a Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities. Level 4: "The Principle & Will ANSI/AAMI PB 70 Sterile Level 4 Surgical Gown/Isolation Gown is a sterile, single-use surgical apparel intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate matter. The non-sterile Level 4 Surgical Gown/Isolation Gown is intended for distribution to re-packager/re-labeler or sterilizer establishments for sterilization using a validated ethylene oxide sterilization method in accordance with ISO 11135 prior to marketing to end users." The Principle & Will ANSI/AAMI PB 70 Sterile/Non-sterile Level 4 Surgical Gown/Isolation Gown meets the ANSI/AAMI PB 70 Level 4 liquid barrier and ASTM F1671 viral barrier performance requirements as well as the other performance requirements of ASTM F2407_F2407M-23a Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities and ASTM F3352 F3352M-23 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities.

Source page: https://510kreport.com/device/K260407
Methodology: https://510kreport.com/methodology