GREAT HANDS MITTS

K962810 · Heelbo, Inc. · FMQ · Oct 9, 1996 · General Hospital

Device Facts

• Record ID: K962810
• Device Name: GREAT HANDS MITTS
• Applicant: Heelbo, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Oct 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Indications for Use

Great Hands Mitts hand restraints are worn like gloves. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others.

Device Story

Great Hands Mitts are wearable hand restraints designed to prevent patients from grasping or pulling out medical lines (catheters, I.V. tubes) or causing self-inflicted injury. The device consists of a cotton-covered mitt filled with polyester, featuring a mesh side with sewn-in finger lanes and a Velcro wrist strap with a D-Ring fastener. Used in clinical settings, the mitts are worn like gloves. They function as a physical barrier to limit hand dexterity and grasping capability. The device benefits patients by maintaining the integrity of life-sustaining medical lines and preventing physical harm.

Clinical Evidence

No clinical data. The device relies on a history of safe use of component materials in the garment industry and the absence of reported skin irritation complaints.

Technological Characteristics

Materials: cotton cover, polyester fill, mesh fabric, Velcro strap, D-Ring fastener. Form factor: glove-like restraint available in adult, infant, toddler, and youth sizes. Non-powered, mechanical restraint.

Indications for Use

Indicated for patients (infants, toddlers, youths, and adults) requiring hand restraint to prevent self-injury, injury to others, or accidental removal of medical lines/catheters.

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

• Great Hands Mitts (K962810)

Submission Summary (Full Text)

{0}

Heelbo, Inc.
1134 N. Homan Ave.
Chicago, IL 60651
312/489-7711
Telex RCA 297-248
800/323-5444
Fax [phone]
K962810

OCT - 9 1996

Heelbo, Inc.
Great Hands Mitts

## Safety and Effectiveness Summary

### 1. Submitter's name, Address and Contact Person

| Submitter | Contact Person |
| --- | --- |
| Heelbo, Inc.
1134 N. Homan Ave.
Chicago, IL | Joseph S. Tokarz, Manager, Regulatory Affairs
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
Ph: [phone], Fax: [phone] |

Date Summary Prepared - July 15, 1996

### 2. Name of Device:
Great Hands Mitts

### 3. Name of Predicate Device(s)
Great Hands Mitts

### 4. Description of Device
Great Hands Mitts are hand restraints that are worn like gloves. The cotton covered mitt is filled with polyester and is covered with a mesh material on one side. The glove-like finger lanes are sewn into the mesh material and a Velcro wrist strap with a D-Ring loop fastener helps secure the glove in place.

The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others.

The Great Hands Mitts are available in one size, and three colors to accommodate adult hands and three sizes, three colors to accommodate infants, toddlers and youths. Below is the listing of stock numbers and availability.

| Stock Number | Description | Color |
| --- | --- | --- |
| 1000, 1000HP, 1000N | adult | white, hot pink, navy |
| 1110, 1110HP, 1110N | infant | white, hot pink, navy |
| 1120, 1120HP, 1120N | toddler | white, hot pink, navy |
| 1130, 1130HP, 1130N | youth | white, hot pink, navy |

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{1}

Heelbo, Inc.
1134 N. Homan Ave. Chicago, IL 60651
312/489-7711
Telex RCA 297-248 800/323-5444
Fax [phone]

Heelbo, Inc.
Great Hands Mitts

## 5. Statement of Intended Use

Great Hands Mitts hand restraints are worn like gloves. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others.

## 6. Statement of Technological Characteristics of the Device

Great Hands Mitts are hand restraints that are worn like gloves. The cotton covered mitt is filled with polyester and is covered with a mesh material on one side. The glove-like finger lanes are sewn into the mesh material and a Velcro wrist strap with a D-Ring loop fastener secures the glove in place.

The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency’s labeling requirements set forth in the draft “Guidance on the Content of Premarket Notification [501(k)] Submissions for Protective Restraints” dated December 1995.

## 7. Biocompatibility Assessment

The subject devices are identical in component materials to the predicate devices. The suppliers of the materials use in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, Heelbo, Inc., is not aware of any reports or complaints of skin irritation associated with these materials.

## 9. Conclusion

Based upon the information presented above it is concluded that the Heelbo Great Hands Mitts are safe and effective for their intended use and are substantially equivalent to the predicate device.

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