← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963477

# PEDIATRIC MITTENS (K963477)

_Deroyal Industries, Inc. · FMQ · Nov 12, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963477

## 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 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6760
- **Device Class:** Class 1
- **Review Panel:** General Hospital
- **Attributes:** Pediatric

## 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.

## Device Story

Pediatric protective restraint device; limits finger, hand, or limb movement. Used in clinical settings to facilitate examinations or prevent patient self-injury/interference. Operated by healthcare professionals; requires physician prescription every 24 hours. Optional limb restraint straps allow attachment to bed or independent use. Benefits include patient protection and controlled clinical environment.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Materials: 100% polyester cool knit, blue purr, 100% cotton white twill tape, hook and loop fasteners. Form factor: Mittens for infant/child. No energy source or software.

## 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 (no 510(k) number provided)
- DeRoyal Industries, Inc. (no 510(k) number provided)

## Submission Summary (Full Text)

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{0}

NOV 12 1996

DeRoyal Industries, Inc.
Pediatric Mittens

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. Pediatric Mittens
COMMON/USUAL NAME: Pediatric 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. Pediatric Mittens are a protective restraint device that are intended for medical purposes to limit pediatric patient finger and hand movements thereby enabling examination or protection of the patient or others. Limb restraint straps that attach to the Pediatric Mittens are optional, if needed.

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

DEVICE INTENDED 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.

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
|  Characteristic | DeRoyal Device | Other Devices  |
| --- | --- | --- |
|  Materials | Primarily comprised of 100% polyester cool knit, blue purr, and 100 % cotton white twill tape. Fasteners are made of hook and loop. | Same  |
|  Size | Infant and child | Same  |
|  Vehicles for Attachment | Attachment to bed is optional, if needed | Same  |
|  Length of use | Doctor must prescribe every 24 hours | Same  |
|  Level of Patient Activity | Finger, hand, or limb interference by pediatric patient | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963477](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963477)

**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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