# K962810: Great Hands Mitts

- Pathway: 510(k) (Traditional)
- Applicant: Heelbo, Inc.
- Decided: Oct 9, 1996 after 83 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) Great Hands Mitts: named in the summary without a submission number

## Indications for use
Great Hands Mitts hand restraints are worn like gloves. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others.

Source page: https://510kreport.com/device/K962810
Methodology: https://510kreport.com/methodology