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DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach is to be used as a generalpurpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and chrome. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach are intended for use in healthcare settings for environmental control of bacteria and viruses, and prevention of cross-contamination. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach tuberculocidal efficacy requires two minutes contact time at room temperature (68-779F, 20-25°C).

DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach

The provided documents are a letter from the FDA regarding a 510(k) submission for a hospital cleaner disinfectant. These documents do not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for a medical device.

Instead, the documents describe the FDA's determination of substantial equivalence for a product named "DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach" and state its intended use as an intermediate level disinfectant for non-critical devices and hard surfaces in healthcare settings.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving a device meets these criteria based on the provided text. The documents are related to regulatory clearance (510(k)), not performance study details.

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