K964749 · Convatec, A Division of E.R. Squibb & Sons · LRJ · Dec 13, 1996 · General Hospital
Device Facts
Record ID
K964749
Device Name
COVERAGE HBV
Applicant
Convatec, A Division of E.R. Squibb & Sons
Product Code
LRJ · General Hospital
Decision Date
Dec 13, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.6890
Device Class
Class 1
Indications for Use
Coverage HBV is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities.
Device Story
Liquid chemical germicide; active ingredients: quaternary ammonium chloride compounds. Used in healthcare facilities for disinfection of hard inanimate surfaces and reusable non-critical medical devices. Applied by healthcare personnel to reduce microbial load. Effectiveness validated against various bacteria (S. aureus, S. choleraesuis, Ps. aeruginosa), fungi (T. mentagrophytes, Aspergillus, Candida, Penicillium), and viruses (Hepatitis B, Influenza, Herpes Simplex, Poliovirus). Safety profile includes acute oral/dermal toxicity data and irritation testing.
Clinical Evidence
Bench testing only. Effectiveness data provided via EPA approval documentation confirming germicidal, fungicidal, and virucidal activity against specified pathogens (S. aureus, T. mentagrophytes, Hepatitis B, etc.). Safety data includes acute oral/dermal LD50, dermal/eye irritation studies, and dermal sensitization testing.
Technological Characteristics
Liquid chemical germicide; active ingredients: quaternary ammonium chloride compounds. Formulated for surface disinfection.
Indications for Use
Indicated for use on hard inanimate surfaces and reusable non-critical medical devices in healthcare facilities to inactivate bacteria, fungi, and viruses.
Regulatory Classification
Identification
A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.
Predicate Devices
Tor Germicidal Cleaner (Huntington Laboratories)
Quat-Syl 256 (National Laboratories)
Futron 25 (Hysan Corp.)
Submission Summary (Full Text)
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DEC 13 1996 510(k) Summary K964749
Trade Name: Coverage HBV
Common/Usual Name: General Purpose Disinfectant
Submitter/Manufacturer: ConvaTec, Division of E.R. Squibb and Sons, Inc.
5035 Manchester Avenue
St. Louis, MO 63110
Establishment Registration Number: 1940768
Contact: Mike Ebers, Manager Regulatory Affairs (314) 535-1390
Description: Coverage HBV is a liquid chemical germicide utilizing quaternary ammonium chloride compounds as active ingredients.
Intended Use: Coverage HBV is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities.
Substantial Equivalence to: (1) Tor Germicidal Cleaner, Huntington Laboratories, (2) Quat-Syl 256, National Laboratories, (3) Futron 25, Hysan Corp.
Comparison to Listed Substantially Equivalent Products: Listed products are also liquid chemical germicides utilizing quaternary ammonium chloride compounds as active ingredients to inactivate specific bacteria, fungi, and viruses on hard inanimate surfaces.
Safety Data: Acute Oral LD₅₀ (Rats) = 5,000 mg/kg
Acute Dermal LD₅₀ (Rabbits) = 2,000 mg/kg
Dermal Irritation (Rabbit) neat = Corrosive. Direct contact can cause moderate to severe redness and swelling.
Eye Irritation (Rabbit) neat = Severe nonreversible irritation.
Eye Irritation (Rabbit) 1:64 aqueous dilution = No irritation
Dermal Sensitization (Guinea Pig) = Negative as sensitizer
Effectiveness Data: Germicidal: Approved by EPA as effective against S. aureus, S. choleraesuis and Ps. aeruginosa and other bacteria.
Fungicidal: Approved by EPA as effective against T. mentagrophytes. Also Aspergillus candidus, Aspergillus niger, Candida albicans, Penicillium chemeseinum, Penicillin oxalicum, Penicillium spinulosum and Ulocladium sp.
Virucidal: Approved by EPA as effective against Avian Influenza/Turkey/Wisconsin Virus, Cytomegalovirus, Hepatitis B Virus, Herpes Simplex type 1 and type 2 Virus, Influenza A Virus, Influenza B Virus, Influenza C Virus, Measles Virus, Newcastle Disease Virus, Parainfluenza type 1 Virus, Poliovirus type 1, Porcine Parovirus, Pseudorabies Virus, T1 bacteriophage, T4 bacteriophage and Vaccinia.
