# K964114: Depuy Opti-Con and E-Z Shield Systems

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: May 6, 1997 after 203 days
- Product code: FXX (Mask, 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. The FDA summary names its predicate without a number.
- (no number) Splash Shield Splash Shields: named in the summary without a submission number
- (no number) DePuy Disposable Filter/Hood: named in the summary without a submission number
- (no number) DePuy Shades™ Protective Glasses: named in the summary without a submission number

## Indications for use
The DePuy Opti-Con and E-Z Shield Systems are intended as face shields to be worn by operating room personnel during surgical procedures to provide splash. protection to protect the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The Opti-Con Shields, E-Z Shield and Opti-Con goggles are intended to be disposable. The Opti-Con head gear is intended to be re-usable.

Source page: https://510kreport.com/device/K964114
Methodology: https://510kreport.com/methodology