← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963469

# MITTENS (K963469)

_Deroyal Industries, Inc. · FMQ · Nov 14, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963469

## Device Facts

- **Applicant:** Deroyal Industries, Inc.
- **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md)
- **Decision Date:** Nov 14, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6760
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

The DeRoyal Industries, Inc. Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Mittens are intended to be attached to a bed.

## Device Story

Protective restraint device; limits hand/finger/limb movement; prevents patient self-injury or interference with medical procedures. Comprised of cotton or polyester fabric; secured via hook and loop or buckle fasteners; attached to bed. Used in clinical settings under physician supervision; requires daily prescription renewal. Benefits include patient safety and facilitation of medical examinations.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Materials: 100% cotton or polyester. Fasteners: hook and loop or buckle. Sizes: S, M, L, XL. Attachment: bed-mounted. Non-electronic, mechanical restraint device.

## Regulatory Identification

A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

## Predicate Devices

- J.T. Posey Company (unspecified)
- DeRoyal Industries, Inc. (unspecified)

## Submission Summary (Full Text)

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NOV 14 1996
DeRoyal Industries, Inc. Mittens
X96-3469
510(k) Summary

# SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

## SUBMITTER INFORMATION

NAME: DeRoyal Industries, Inc.
ADDRESS: 200 DeBusk Lane
Powell, TN 37849
TELEPHONE: (423) 938-7828
CONTACT: Camille Matlock
DATE OF PREPARATION: August 30, 1996

## DEVICE NAMES

NAME: DeRoyal Industries, Inc. Mittens
COMMON/USUAL NAME: Mittens
CLASSIFICATION NAME (if known): Restraint, Protective (80FMQ)

## PREDICATE OR LEGALLY MARKETED DEVICES

J.T. Posey Company
DeRoyal Industries, Inc.

## DEVICE DESCRIPTION

The DeRoyal Industries, Inc. Mittens are a protective restraint device that are intended for medical purposes to control hand and finger movements and/or limit limb movements thereby enabling examination or protection of the patient or others.

**Device Design/Materials Used/Physical Properties:** The DeRoyal Mittens are designed similar to those marketed by other manufacturers. The Mittens are primarily comprised of 100% cotton or polyester with hook and loop or buckle fasteners.

## DEVICE INTENDED USE

The DeRoyal Industries, Inc. Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Mittens are intended to be attached to a bed.

## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

|  Characteristic | DeRoyal Device | Other Devices  |
| --- | --- | --- |
|  Materials | Primarily comprised of 100% cotton or polyester | Same  |
|  Size | Small, Medium, Large, and Extra-Large | Same  |
|  Vehicles for Attachment | Bed | Same  |
|  Length of use | Doctor must prescribe every 24 hours | Same  |
|  Level of Patient Activity | Mildly agitated
Limb interference by patient | Same  |

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963469](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963469)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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