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A twisted condom obstructs urine flow, causing urine pooling, skin irritation, and weakening and deterioration of the adhesive.
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The basic idea of a tensile test is to place a sample of a material between two fixtures called grips which clamp the material.
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Although studies say that nonoxynol-9 spermicide kills HIV in lab examination, it has non been determined whether spermicides, used solitary or with condoms, provide protection against hiv.
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This report updates laboratory and medical specialty information regarding the effectiveness of condoms in preventing HIV infection and opposite stds and the role of spermicides used together with condoms.
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What is the leading cause of breakage in male condoms?
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Well-nig condoms stretch to over 750% of their original width.
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What are the processes used to make condoms?
Manufacturing Processes Provide the following information on the processes used to manufacture the condom: 1. flow diagram for all aspects of condom manufacturing including points where in-line quality control testing is performed; 2. solvent based manufacturing process (blown, spun or dipped): OR See C.3.
How many condoms should be used in a trial?
FDA recommends a randomized, cross-over study design for the slippage and breakage study. In general, at least 1000 uses of each type condom should be documented. A sufficient number of couples should be enrolled in the trial to ensure that each couple uses between three (3) and five (5) condoms of each type.
What is clinical testing guidance for male condoms?
PART B - CLINICAL TESTING GUIDANCE FOR NEW MATERIAL MALE CONDOMS Introduction This section of the guidance addresses the clinical testing requirements for any new male latex or new material condom that differs significantly from conventional condoms in its design, materials, or technological characteristics.
Do you know the shelf life of condoms?
Shelf-Life Real-time and/or accelerated data is necessary to substantiate the claimed shelf-life.
Last Update: Oct 2021
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