# K963458: Padded Mitts/Padded-Plus Mitts/Finger Separator Padded Mitts/Rigid Palm Padded Mitts

- Pathway: 510(k) (Traditional)
- Applicant: Skil-Care Corp.
- Decided: Oct 18, 1996 after 45 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) Padded Mitts: named in the summary without a submission number
- (no number) Padded-Plus Mitts: named in the summary without a submission number
- (no number) Finger Separator Padded Mitts: named in the summary without a submission number
- (no number) Rigid Palm Padded Mitts: named in the summary without a submission number

## Indications for use
Padded Mitts, Padded-Plus Mitts, Rigid Palm Padded Mitts, and Finger Separator Padded Mitts are intended for patients who remove bandages and dressings, pick and scratch at wounds, grasp and pull out feeding and naso-gastric tubes. Rigid Palm Padded Mitts have a rigid insert and are intended for patients who require an additional barrier to prevent grasping. Finger-Separator Padded Mitts have finger channels that help to control hand contracture.

Source page: https://510kreport.com/device/K963458
Methodology: https://510kreport.com/methodology