JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY

K961227 · J.J. Skinner, Inc. · FRG · Jun 10, 1996 · General Hospital

Device Facts

• Record ID: K961227
• Device Name: JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
• Applicant: J.J. Skinner, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Jun 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is intended to be used by Healthcare professionals for wound care management, including, cleansing, irrigation, debridement, and dressing changes.

Device Story

Assembly of medical products for wound care management; includes various legally marketed, exempt, or grandfathered medical devices; packaged in sterile Tyvek®/polyethylene pouch; disposable, single-use; intended for healthcare professional convenience; facilitates cleansing, irrigation, debridement, and dressing changes; no new uses claimed.

Clinical Evidence

No clinical evaluations were completed.

Technological Characteristics

Sterile, disposable, single-use tray; components packaged in Tyvek®/polyethylene pouch; assembly of legally marketed medical devices for wound care.

Indications for Use

Indicated for healthcare professionals performing wound care management, including cleansing, irrigation, debridement, and dressing changes.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Submission Summary (Full Text)

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JUN 10 1996
K961227

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## 510(K) SUMMARY

### JJ Skinner CareKits™
Wound Care Management/Dressing Change Tray

**Submitter Information:**

JJ Skinner Inc.
Stark Bldg. Suite 825
455 South Fourth Avenue
Louisville, KY 40202

**510(k) Summary Prepared By:**

Carolann Kotula
mdi Consultants, Inc.
55 Northern Blvd.
Great Neck, NY 11021
[phone]

**Date 510(k) Summary Prepared:** March 20, 1996

**Name of the Device:**

**Trade or Proprietary Name:** JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray

**Common Name:** Wound care kit/tray; dressing change kit/tray

**Classification Name:** Kit, Wound Dressing (Product Code: 79MCY)

**Identification of Legally Marketed Device to which the Submitter Claims Equivalence:**

The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is an assembly of medical products sterilized within a Tyvek®/polyethylene pouch. The trays are sterile, disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the tray are commonly used for wound

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management, and JJ Skinner is not claiming or causing new uses through the intended use of the tray.

## Intended Use of the Subject Devices:

The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is intended to be used by Healthcare professionals for wound care management, including, cleansing, irrigation, debridement, and dressing changes.

## Technological Characteristics of the Subject Device:

The technological characteristics of JJ Skinner CareKits™ Wound Care Management/Dressing Change Trays and the predicate device are substantially equivalent as supported by the comparison of similar significant features, components, and intended use.

No clinical evaluations were completed.