# K963477: Pediatric Mittens

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Nov 12, 1996 after 70 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) J.T. Posey Company: named in the summary without a submission number
- (no number) DeRoyal Industries, Inc.: named in the summary without a submission number

## Indications for use
The DeRoyal Industries, Inc. Pediatric Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient finger, hand, and/or limb movements thereby enabling examination or protection of the patient or others. The Pediatric Mittens can be attached to a bed or used alone.

Source page: https://510kreport.com/device/K963477
Methodology: https://510kreport.com/methodology