COVERAGE HBV
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.)
Related Devices
- K962739 — T.B.Q. · Convatec, A Division of E.R. Squibb & Sons · Oct 7, 1996
- K964835 — COVERAGE SPRAY HBV · Convatec, A Division of E.R. Squibb & Sons · Dec 16, 1996
- K974304 — GERMICIDAL CLOTH · Convatec, A Division of E.R. Squibb & Sons · Jan 13, 1998
- K983947 — AMERSE 2 · STERIS Corporation · Dec 4, 1998
- K980369 — T.B.Q. RTU · STERIS Corporation · Feb 17, 1998
