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510(k) Data Aggregation
K Number
K091890Device Name
EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
Manufacturer
HEALTHPOINT, LTD.
Date Cleared
2010-03-24
(274 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
HEALTHPOINT, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Extended Use Aldahol High Level Disinfectant is intended for the high level disinfection of reusable, clean, heat-sensitive, semi-critical medical devices which contact intact mucous membranes when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 5.0 min at 25℃ in an automated endoscope reprocessor with FDA-cleared capability to maintain the exposure of 5.0 min at 25°C.
Extended Use Aldahol High Level Disinfectant is intended for the sterilization of reusable, clean, heat-sensitive critical and semi-critical medical devices which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 6.0 hrs at 25℃.
Device Description
Extended Use Aldahol High Level Disinfectant (HLD) is an aqueous solution that requires the combination of two parts, the unactivated Extended Use Aldahol HLD solution, packaged in gallon-sized containers, and a red Activator Buffer Salt Solution packaged in a smaller container included with the unactivated Extended Use Aldahol HLD solution container.
Once activated, the red/red-orange Extended Use Aldahol HLD as manufactured contains 3.4% w/w of glutaraldehyde and 20.1% w/w of isopropanol in a buffered salt solution of a surfactant, and potassium acetate intended to enhance the antimicrobial activity of the glutaraldehyde.
The microbial mode of action of glutaraldehyde has been extensively studied and reviewed since glutaraldehyde was introduced as a disinfectant in the late 1960's. All of these reviews indicate that glutaraldehyde cross-links proteins and lipoproteins of microbes to denature the proteins and lipoproteins, thus killing the cells.
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K Number
K041360Device Name
ALDAHOL III HIGH-LEVEL DISINFECTANT
Manufacturer
HEALTHPOINT, LTD.
Date Cleared
2005-05-05
(349 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
HEALTHPOINT, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterilization: Aldahol III High-Level Disinfectant is a sterilant intended for the sterilization of reusable, clean, heat-sensitive medical devices when used as directed at or above its minimum recommended concentrations (MRC) of 2.1% alkaline glutaraldehyde and 15.0% isopropanol with an exposure of 10.0 hrs at 20 C.
High-Level Disinfection: Aldahol III High-Level Disinfectant is a high-level disinfectant intended for the disinfection of reusable, clean, heat-sensitive medical devices when used as directed at or above its MRC of 2.1% alkaline glutaraldehyde and 15.0% isopropanol with an exposure of 10.0 min at 20 C.
Device Description
Aldahol III High-Level Disinfectant is a liquid chemical sterilant and high-level disinfectant. It is a glutaraldehyde-based disinfectant with a glutaraldehyde concentration in the range of 2.4 to 3.4%. When activated with buffer salts to an alkaline pH value of about 7.6, the glutaraldehyde concentration can remain constant over a 14-day use and reuse life. It also contains about 25% isopropanol to enhance mycobactericidal (TB) activity.
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