Who is the manufacturer of MITTENS?

Deroyal Industries, Inc. filed the 510(k) submission for MITTENS (K963469).

What is the FDA product code for MITTENS?

FMQ. It is classified under 21 CFR 880.6760 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for MITTENS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MITTENS?

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

Who can help prepare an FDA 510(k) submission like MITTENS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MITTENS

K963469 · Deroyal Industries, Inc. · FMQ · Nov 14, 1996 · General Hospital

Device Facts

Record ID	K963469
Device Name	MITTENS
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Nov 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1

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.

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.

Indications for Use

Indicated for patients requiring limb movement limitation for examination or protection of patient/others; used at discretion of licensed healthcare professional; requires prescription every 24 hours; applicable for mildly agitated patients or those with limb interference.

Regulatory Classification

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)

Related Devices

K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963474 — TUXEDO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963467 — ROLL BELTS · Deroyal Industries, Inc. · Jan 3, 1997
K963477 — PEDIATRIC MITTENS · Deroyal Industries, Inc. · Nov 12, 1996
K963413 — MULTIPLE LIMB HOLDERS · J. T. Posey Co. · Nov 14, 1996

Submission Summary (Full Text)

{0} 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 |