ALLCLENZ WOUND CLEANSER

K965120 · Dpt Laboratories, Ltd. · KMF · Mar 21, 1997 · General Hospital

Device Facts

• Record ID: K965120
• Device Name: ALLCLENZ WOUND CLEANSER
• Applicant: Dpt Laboratories, Ltd.
• Product Code: KMF · General Hospital
• Decision Date: Mar 21, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For the cleansing of dermal lesions such as stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritation of the skin.

Device Story

Allclenz™ Wound Cleanser; colorless, transparent solution; supplied in 12 fl. oz. plastic bottles with trigger-spray. Used for irrigation and cleansing of dermal wounds. Applied topically by clinicians or patients to clean wound sites. Facilitates removal of debris from wound bed; supports wound healing environment.

Clinical Evidence

Bench testing only. Biocompatibility established via primary dermal irritation (rabbit), ocular irritation (rabbit), sensitization (guinea pig), and in vitro cytotoxicity studies.

Technological Characteristics

Liquid wound cleanser; supplied in plastic bottles with trigger-spray mechanism. Non-sterile. Biocompatibility verified via standard animal and in vitro models.

Indications for Use

Indicated for cleansing dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions, and minor skin irritations.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Dermagran Wound Cleanser with Zinc (K945802)

Submission Summary (Full Text)

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MAR 20 '97 15:38 R
P.3

# 510 (k) SUMMARY

K965120

## I. ADMINISTRATIVE

Submitter: Healthpoint Medical
307 E. Josephine Street
San Antonio, Texas 78215
1-800-441-8227

MAR 21 1997

Contact Person: John Maverick

Date of Preparation: March 20, 1997

## II. DEVICE NAME

Proprietary Name: Allclenz™ Wound Cleanser

Common Name: Wound Cleanser

Classification Name: Liquid bandage

## III. PREDICATE DEVICE

Dermagran Wound Cleanser with Zinc; Derma Sciences, Inc.; K945802; 2/27/95.

## IV. DEVICE DESCRIPTION

The Allclenz™ Wound Cleanser is a colorless, transparent solution supplied non-sterile in 12 fl. oz. plastic bottles equipped with trigger-spray intended for cleansing and irrigation of dermal wounds.

Biocompatibility of the product has been established by primary dermal irritation (rabbit), ocular irritation (rabbit), sensitization (guinea pig), and in vitro cytotoxicity studies.

## V. INTENDED USE

For the cleansing of dermal lesions such as stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritation of the skin.

## VI. COMPARISON TO PREDICATE DEVICES

The Allclenz™ Wound Cleanser is similar in composition, function and intended use to the Dermagran Wound Cleanser with Zinc (Derma Sciences, Inc.) and other similar wound cleansers.

Accordingly, Healthpoint Medical concluded that the Allclenz™ Wound Cleanser is safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the Dermagran Wound Cleanser with Zinc.

Premarket Notification. Allclenz™ Wound Cleanser