# K011789: Procedure Masks: PM4-301 and PM4-304

- Pathway: 510(k) (Special)
- Applicant: Primeline Medical Products, Inc.
- Decided: Jun 22, 2001 after 14 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intcnded to be worn by opcrating room personnc! during surgical procedurcs to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulatc matcrial.

Source page: https://510kreport.com/device/K011789
Methodology: https://510kreport.com/methodology