# K971130: Defend Fluid Resistant Pleated Mask

- Pathway: 510(k) (Traditional)
- Applicant: Carl Parker Associates, Inc.
- Decided: Jun 27, 1997 after 92 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) Technol: named in the summary without a submission number

## Indications for use
Intended to be worn by operating room personnel 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/K971130
Methodology: https://510kreport.com/methodology