# K963422: Protective Restraint (Protective Mitt)

- Pathway: 510(k) (Traditional)
- Applicant: Kenad SG Medical, Inc.
- Decided: Nov 22, 1996 after 84 days
- Product code: FMQ (Restraint, Protective)
- Device class: 1
- Regulation: 21 CFR 880.6760
- 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) Protective Mitts from Danek Medical, Inc.: named in the summary without a submission number

## Indications for use
Kenad Protective Mitts are indicated for medical purposes where hand and finger movement must be limited to prevent grasping tubes or picking or scratching dressings and wounds.

Source page: https://510kreport.com/device/K963422
Methodology: https://510kreport.com/methodology