# K991559: Medline Prohibit Series Surgical Mask with Fluid Shield

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Aug 23, 1999 after 111 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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.

## Most influential descendants
- K100846: Imc Surgical Face Mask (2010), 3 descendants of its own
- K212375: Disposable Medical Surgical Mask (2022), 0 descendants of its own
- K202954: Disposable Surgical Mask (2021), 0 descendants of its own
- K210429: Disposable Surgical Face Mask (2021), 0 descendants of its own

## Indications for use
A surgical mask is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K991559
Methodology: https://510kreport.com/methodology