Recovery is least 5 per not specified mL Test Article N/A N/A N/A 5 mL of the 1.5 ml of a test 5 mL of the Volume 3 ml applied 3 ml Application test product material test material specified by and washed applied Details: during (calculations for manufacturer for 30 or 60 and Wash for handwashing foaming materials sec +15 sec rubbed for 30±5 sec, using 40°C provided) or 30 rinse for 30±5 water for 1 following seconds, sec min manufacturer then handwashing instructions sampled Number of N/A N/A N/A Not specified At least 8 subjects At least 8 At least 6 At least 12 18-22 Subjects / subjects subjects subjects subjects FDA CDER asks Total depends on Replicates for at least 12 number of test (Minimum, subjects materials, study Recommended) purpose, and regulatory requirements governing the study. Internal None None Referenced None None None None Soft soap 2x3ml of Reference: Chlorine solution (British 60% isopropanol 1993) 200g/L rubbed for 60 seconds total
Recovery is not specified least 5 per mL Test Article Application Details: N/A N/A N/A 5 mL of the test product during handwashing using 40°C water for 1 min handwashing 1.5 ml of a test material (calculations for foaming materials provided) 5 mL of the test material Wash for 30±5 sec, rinse for 30±5 sec Volume specified by manufacturer 3 ml applied and washed for 30 or 60 sec +15 sec or following manufacturer instructions 3 ml applied and rubbed for 30 seconds, then sampled Number of Subjects / Replicates (Minimum, Recommended) N/A N/A N/A Not specified FDA CDER asks for at least 12 subjects At least 8 subjects Total depends on number of test materials, study purpose, and regulatory requirements governing the study. At least 8 subjects At least 6 subjects At least 12 subjects 18-22 subjects Internal Reference: None None Referenced Chlorine solution None None None None Soft soap (British 1993) 200g/L 2x3ml of 60% isopropanol rubbed for 60 seconds total
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