Who is the manufacturer of PEDIATRIC MITTENS?

Deroyal Industries, Inc. filed the 510(k) submission for PEDIATRIC MITTENS (K963477).

What is the FDA product code for PEDIATRIC 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 PEDIATRIC MITTENS?

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

What are the predicate devices for PEDIATRIC MITTENS?

J.T. Posey Company (no 510(k) number provided); DeRoyal Industries, Inc. (no 510(k) number provided).

Who can help prepare an FDA 510(k) submission like PEDIATRIC 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.

PEDIATRIC MITTENS

K963477 · Deroyal Industries, Inc. · FMQ · Nov 12, 1996 · General Hospital

Device Facts

Record ID	K963477
Device Name	PEDIATRIC MITTENS
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Nov 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1
Attributes	Pediatric

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.

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.

Indications for Use

Indicated for pediatric patients requiring limitation of finger, hand, or limb movement to facilitate medical examination or ensure safety of patient/others. Use at discretion of licensed healthcare professional.

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

Related Devices

K963466 — PEDIATRIC LIMB HOLDER · Deroyal Industries, Inc. · Feb 13, 1997
K963439 — PEDIATRIC LIMB HOLDERS · J. T. Posey Co. · Nov 19, 1996
K963469 — MITTENS · Deroyal Industries, Inc. · Nov 14, 1996
K963413 — MULTIPLE LIMB HOLDERS · J. T. Posey Co. · Nov 14, 1996
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997

Submission Summary (Full Text)

{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 |