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
Indications for 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.
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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
