COVERAGE SPRAY HBV

K964835 · Convatec, A Division of E.R. Squibb & Sons · LRJ · Dec 16, 1996 · General Hospital

Device Facts

• Record ID: K964835
• Device Name: COVERAGE SPRAY HBV
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: LRJ · General Hospital
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6890
• Device Class: Class 1

Indications for Use

Coverage Spray 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

Coverage Spray HBV; liquid chemical germicide; active ingredients quaternary ammonium chloride compounds. Applied to hard inanimate surfaces and reusable non-critical medical devices in healthcare facilities. Inactivates specific bacteria, fungi, and viruses. Used by healthcare personnel for environmental and equipment disinfection. Benefits patient by reducing risk of cross-contamination via surface contact.

Clinical Evidence

Bench testing only. Safety data: Acute Oral LD50 (rats) 5,000 mg/kg; Acute Dermal LD50 >2,000 mg/kg; Dermal Irritation (rabbit) mild transient; Eye Irritation (rabbit) mild transient; Dermal Sensitization (guinea pig) negative. Effectiveness: EPA-approved for S. aureus, S. choleraesuis, Ps. aeruginosa, pathogenic fungi, Aspergillus niger, Hepatitis B, HIV-1, Herpes simplex 1/2, Parainfluenza 1, Pseudorabies, Influenza A2, Influenza B, and Measles.

Technological Characteristics

Liquid chemical germicide; active ingredients: quaternary ammonium chloride compounds.

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)

{0}

510(k) Summary

Trade Name: Coverage Spray HBV

DEC 16 1996 K944835

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 [phone]

Description: Coverage Spray HBV is a liquid chemical germicide utilizing quaternary ammonium chloride compounds as active ingredients.

Intended Use: Coverage Spray 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 $\mathrm{LD}_{50}$ (Rats) = 5,000 mg/kg
Acute Dermal $\mathrm{LD}_{50} = >2,000\mathrm{mg / kg}$
Dermal Irritation (Rabbit) neat = Produced mild transient redness and swelling
Eye Irritation (Rabbit) neat = Produced mild transient eye irritation.
Dermal Sensitization (Guinea Pig) = Negative as sensitizer

Effectiveness Data: Germicidal: Approved by EPA against S. aureus, S. choleraesuis and Ps. aeruginosa and other bacteria.
Fungicidal: Approved by EPA against pathogenic fungi and Aspergillus niger
Virucidal: Approved by EPA against Hepatitis B Virus, HIV-1, Herpes simplex Type 1 and Type 2 Virus, Parainfluenza Type 1 Virus, Pseudorabies Virus, Influenza A₂ Virus, Influenza B Virus, and Measles Virus