PROTECTIVE RESTRAINT (PROTECTIVE MITT)

K963422 · Kenad SG Medical, Inc. · FMQ · Nov 22, 1996 · General Hospital

Device Facts

• Record ID: K963422
• Device Name: PROTECTIVE RESTRAINT (PROTECTIVE MITT)
• Applicant: Kenad SG Medical, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Indications for Use

Kenad Protective Mitts are indicated for medical purposes where hand and finger movement must be limited to prevent grasping tubes or picking or scratching dressings and wounds.

Device Story

Protective mitts designed to limit hand and finger movement; prevents patient from grasping tubes or picking at dressings/wounds. Device consists of two-sided flexible mitt (polyurethane interior, polyester foam exterior), nylon mesh port covering, and wrist strap with polypropylene/nickel-plated buckle. Optional inflexible aluminum stays inserted to further restrict hand motion. Used in clinical settings; applied by healthcare providers. Hand placed in mitt, secured at wrist with Velcro and strap/buckle; strap can be anchored to limit limb movement. Benefits patient by preventing self-injury or accidental removal of medical equipment.

Clinical Evidence

No clinical trials performed. Evidence based on 5-year post-market performance history. Over 5,000 pairs sold with estimated 10,000+ patient uses. Zero reports of patient injury or product failure documented during this period.

Technological Characteristics

Materials: Polyurethane (interior), polyester foam (exterior), nylon mesh, polypropylene (strap), nickel-plated buckle, aluminum (stays). Form factor: Mitt with wrist closure and optional rigid stays. Non-powered, mechanical restraint device.

Indications for Use

Indicated for adults and children requiring limitation of hand and finger movement to prevent interference with medical devices, dressings, or wounds.

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

• Protective Mitts (Danek Medical, Inc., 1982)

Submission Summary (Full Text)

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# 510(k) SUMMARY

## 1. PERSONNEL AND DATE (807.92(a)(1))

### 1.1. Submitter

Kenad SG Medical Inc.
2692 Huntley
Memphis, TN 38132

### 1.2.. Contact Person

Kenneth Elmore
President and CEO
Kenad SG Medical Inc.

### 1.3.. Date Of summary Preparation

This summary was prepared in July thru August 1996.

## 2. DEVICE NAME (807.92(a)(2))

As noted in the Cover Letter, six similar devices are grouped within this 510(k) notification. These devices differ only in minor design aspects. Their function, application and use is identical.

### 2.1. Trade Or Proprietary Name

Protective Mitt is the trade or proprietary name for the devices which are the subject of this Premarket Notification Submission. Within this name, there are four Kenad Protective Mitts.

| KENAD Catalog # | Description | KENAD Catalog # | Description |
| --- | --- | --- | --- |
| 50-1000 | Adult w/o stays | 50-1100 | Adult w/ stays |
| 50-1010 | Child w/o stays | 50-1110 | Child w/ stays |
| 50-1020 | Infant w/o stays | 50-1120 | Infant w/ stays |

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2.2. Common Or Usual Name

Protective Restraint 21CFR 880.6760

3. LEGALLY MARKETED DEVICE (807.92(a)(3))

The Kenad Protective Mitts subject to this Premarket Notification Submission are comparable to Protective Mitts from Danek Medical, Inc. Danek filed a premarket notification for Protective Mitts November 23, 1982

4. DEVICE DESCRIPTION (807.92(a)(4))

4.1. General Description

The Kenad Protective Mitts subject to this Premarket Notification are devices that comprise the following modules, cited in this document

Mitt- Two sided flexible material. The inside, which faces the hand, is polyurethane, and the outside is polyester foam.

Mesh Port Covering- Nylon mesh.

Wrist Strap and Buckle- Flexible polypropylene and polished nickle plated buckle.

Stay- Inflexible aluminum strip.

4.2. How Protective Mitts Function

The hand is placed into the mitt which is comfortably fitted at the wrist with a Velcro closure. The wrist is then snugly surrounded by the Wrist Strap and Buckle.

If needed, the Wrist Strap can be joined via a Quick release Buckle to an Anchor Strap to limit limb movement.

Stays placed in some mitts limit mitt flexibility to limit hand motion within the mitt.

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5. INTENDED USE (807.92(a)(5))

5.1. Indications

Kenad Protective Mitts are indicated for medical purposes where hand and finger movement must be limited to prevent grasping tubes or picking or scratching dressings and wounds.

5.2. Patient Population

Kenad Protective Mitts are used with adults and children.

5.3. Indications Different From Substantially Equivalent Device

Indications and patient populations for the Kenad devices are identical to the legally marketed device cited in this document.

6. COMPARISON TO LEGALLY MARKETED DEVICE (807.92(a)(6))

Kenad Protective Mitts are comparable to Protective Mitts from Danek Medical, Inc. A comparison of these devices are provided in this Premarket Notification Submission.

7. PERFORMANCE DATA (807.92(b))

More than 5000 pairs of Kenad Protective Mitts were sold over the last 5 years. Assuming 100% usage, there have been more than 10,000 patient hand contacts over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about the Protective Mitts.

8. SAFETY, EFFICACY AND PERFORMANCE CONCLUSION (807.92(b)(3))

The absence of patient injury or product failure complaints following more than 10,000 product uses over 5 years indicates these products are safe and effective.

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