# K971076: Primed Shoe Covers, Primed Head Covers

- Pathway: 510(k) (Traditional)
- Applicant: Primeline Medical Products, Inc.
- Decided: Jan 13, 1998 after 295 days
- Product code: FXP (Cover, Shoe, Operating-Room)
- Device class: 1
- 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
Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K971076
Methodology: https://510kreport.com/methodology