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510(k) Data Aggregation
K Number
K091210Device Name
ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT
Manufacturer
BEST SANITIZERS, INC.
Date Cleared
2010-02-05
(287 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
BEST SANITIZERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ACECIDE-C is a high level disinfectant intended to disinfect reusable clean heatsensitive semi-critical medical devices (such as flexible endoscopes) which contact mucous membranes when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 7.0 minutes at 20°C.
ACECIDE-C is a sterilant intended to sterilize reusable clean heat-sensitive critical and semi-critical medical devices (such as flexible endoscopes) which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 2.0 hours at 20℃.
ACECIDE Test Strips are used with ACECIDE-C High Level Disinfectant and Sterilant use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm.
Device Description
ACECIDE-C High-Level Disinfectant and Sterilant is packaged in two separate plastic bottles: ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 is a concentrate of acetic acid and hydrogen peroxide, which react with each other in the presence of a catalyst and stabilizer to form 6.2 - 6.8 % w/w peracetic acid at a pH value of <1. ACECIDE-C Buffer Concentrate Solution 2 contains a sequestrant, an anti-corrosive, and buffer salts for a pH value of about 8.7 to 9.7. At the time of use, one part of ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 and one part of the ACECIDE-C Buffer Concentrate Solution 2 is mixed with 18 parts of tap water at 20℃ for a final concentration of 3100 - 3400 ppm peracetic acid.
ACECIDE Test Strips are used with ACECIDE-C use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm. The test strips are based on the same basic chemistry as other peracetic acid test strips and assay methods. Peracetic acid oxidizes iodide to iodine with starch forming a visible blue-gray/blue-black compound with iodine. This color change in the indicator paper is the visual basis for the tests strips and their reading.
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K Number
K041984Device Name
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
Manufacturer
BEST SANITIZERS, INC.
Date Cleared
2005-05-11
(292 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
BEST SANITIZERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acecide High-Level Disinfectant and Sterilant is intended to be used for the automated sterilization or high-level disinfection of clean, heat sensitive, critical or semi-critical medical devices that are not compatible with other sterilization or high-level disinfection processes that can be biologically monitored.
Acecide High-Level Disinfectant and Sterilant should be used under the following contact conditions:
Sterilization: Time 5 hours, Temperature 25°C, Minimum Recommended Concentration of Peracetic Acid 1900 ppm
High-Level Disinfection: Time 5 minutes, Temperature 25°C, Minimum Recommended Concentration of Peracetic Acid 1900 ppm
Acecide Peracetic Acid Test Strips are intended for verifying the minimum recommended concentration of peracetic acid in Acecide High-Level Disinfectant and Sterilant during reuse.
Device Description
Acecide High-Level Disinfectant and Sterilant is a germicide that requires the combination of two parts, Solution 1 and Solution 2, within the Solution 2 bottle. The product is used full strength without dilution. It is packaged in two High Density Polyethylene bottles.
The active ingredients in Acecide High-Level Disinfectant and Sterilant are peracetic acid and hydrogen peroxide. As discussed in Block's article, the mechanism of microbial action is believed to be oxidizing sulthydryl and sulfur bonds on proteins and enzymes, particularly in the cell walls.
Acecide Peracetic Acid Test Strops are provided to verify that the minimum recommended concentration, 1900 ppm peracetic acid (PAA) of Acecide High-Level Disinfectant and Sterilant is present.
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