← Product Code [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF) · K965120 # ALLCLENZ WOUND CLEANSER (K965120) _Dpt Laboratories, Ltd. · KMF · Mar 21, 1997 · General Hospital · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K965120 ## Device Facts - **Applicant:** Dpt Laboratories, Ltd. - **Product Code:** [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF.md) - **Decision Date:** Mar 21, 1997 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5090 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **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. ## Regulatory 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](/device/K945802.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K965120](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K965120) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com