# K142166: Total Shield Surgical;Toga (Regular, Large,X-Large);Hood; Helmet Advanced Helmet W/Led Lighting, Total Shield Accessories

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Aug 28, 2014 after 29 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
Longest line of descent: 2 generations back to K102971 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132386: Totalshield Surgical Helmet System, Zimmer, Inc. (2013) Summary page 4.

## Indications for use
The TotalShieldTM Zippered Surgical Toga and/or TotalShieldTM Surgical Hood is for use with the TotalShieldTM Surgical Helmet and/or TotalShieldTM Advanced Surgical Helmet with LED lighting as the TotalShieldTM Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Source page: https://510kreport.com/device/K142166
Methodology: https://510kreport.com/methodology