# K991617: Face-2-Face  CPR Protection Shield

- Pathway: 510(k) (Traditional)
- Applicant: Whiteline Plastics, Inc.
- Decided: Nov 3, 1999 after 177 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- 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
The above named device is designed to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins. “The use of this device does not gaurantee complete protection from disease transmission

Source page: https://510kreport.com/device/K991617
Methodology: https://510kreport.com/methodology