# K963504: Medline Open End Finger Control Mitt

- Pathway: 510(k) (Traditional)
- Applicant: Medline
- Decided: Oct 29, 1996 after 56 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 no predicate by number.

## Indications for use
Medline Hand Protectors and Finger Control Mitts may be used with either a wheelchair or a bed. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. May be used with stroke patients to help prevent contracture or to help fingers in rehabilitation. Effectively helps minimize the possibility of the patient removing catheters and IV tubes and helps prevent scratching and itching.

Source page: https://510kreport.com/device/K963504
Methodology: https://510kreport.com/methodology