Alternative Condoms - Caution Wear Corp. - Manufacturing and Marketing of Male Latex Condoms

Call: 603-598-8500

     The first recorded use of condoms was in Egypt in 1350 b.c. In 1564, the Italian anatomist      Fallopius described a linen condom used to prevent venereal disease. The term condom is      actually a corruption of the name of an 18th-century British physician, Dr. John Conton,
     who provided condoms to France's King Charles II. The legendary lover Giovanni Casanova
     (1725-1798) used pieces of sheep intestine to protect himself against venereal disease.
     The first condom manufacturer in the U.S. was Schmid Laboratories. In 1883, Julius Schmid,
     a former sausage skin-maker, acquired a business that manufactured bottle seals from
     animal membranes. Five years later, Schmid used his experience with sausage casings
     and capping skins to manufacture prophylactic sheaths from lamb cecum.

     Even as Schmid was marketing his skin condoms, technology was progressing to allow
     thinner, more pliable, and less expensive condoms to became available. Vulcanization,
     the chemical linking of rubber particles that was originally developed in 1839 for use in      automobile tires, made condoms strong, durable, and fit for consumer use. A form of rubber      called latex was developed in the 1930s; this new material, combined with a mechanized      dipping process, facilitated the mass production of condoms and lowered manufacturing
     costs.

     Rubber latex is obtained from the milky fluid produced by various tropical plants. Latex is
    actually an emulsion or dispersion of tiny rubber particles in water, and ingredients added
     to the latex must be able to attach to the rubber particles during compounding.

     The latex and chemical compound is then unloaded into drums for storage, where it
     remains for approximately seven days. During this period, vulcanization chemically      strengthens the bonds of the rubber. The storage time also allows any air, which might
     have been trapped in the mixture during compounding, to escape.

     The compound is then added to the dipping or condom-forming machine. The dipping
     machine is a long, hooded machine approximately 100 feet (30.5 m) in length. Thick      tempered glass rods move along a closed belt between two circular gears. The belt drags
     the rods, which are called mandrels, through a series of dips into the latex compound. The      mandrels rotate to spread the latex evenly. Several coats are required to build the condom
     to its required thickness. Between each dip, the latex is hot air dried. After the final dipping
     and drying, the condoms automatically roll off the mandrels. A machine shapes and trims
     the ring of latex at the base of each condom.

Next, the condoms are put in a tumbling machine, where they are coated with talc or another similar powder to prevent the rubber from sticking to itself.

     1. After a curing period of several days, the condoms are sampled by batch and tested
     for leaks and strength. The first such test is the inflation test, in which the condom is filled
     with air until it bursts. Condoms are required to stretch beyond 1.5 cubic feet, about the
     size of a watermelon, before bursting. This test is considered most important because the      elasticity of the condom keeps it from tearing during intercourse.
     2. In the water-leakage test, the condom is filled with 10 ounces (300 ml) of water and      inspected for pin-sized holes by rolling it along blotter paper.
     3. Condoms are also tested electronically. This involves mounting each condom on a
     charged stainless steel mandrel. The mandrel is passed over by a soft, conductive brush.
     If pin holes are present, a circuit will be established with the mandrel, and the machine will      automatically reject the condom.

Condoms that have successfully passed all tests are rolled by a machine. Rolling the condom makes it easier to package and use. Lubricant and spermicide may be applied
by a metering pump just before the top wrap is added in the foiling process.

     Condoms are classified as Class II Medical Devices. According to the Medical Device      Amendments of 1976 of the FDA, the FDA is required to inspect each condom manufac-
     turing plant at least once every two years. All electrical and mechanical equipment must
     be impeccably maintained. Condom-dipping machines are designed to operate continuously;
     if they remain idle, their mechanisms can get clogged and rust. During any downtime,
     partially cured compound cannot be left in the dip tank because it could contaminate future      production.

     All condoms sold in the U.S. must comply to specifications that were voluntarily developed
     by condom manufacturers and adopted by the FDA. Condom measurements can range
     from 5.8-7.8 inches (150-200 mm) in length, 1.8-2.1 inches (47-54 mm) in width, 0.001 -
     0.003 inches (0.03-0.09 mm) in thickness (although most condoms range between 0.002
     and 0.0024 inches), and the weight cannot exceed 0.07 ounces (2 grams). Additionally,
     physical characteristics must include a minimum tensile strength of 15,000 pounds psa and      elongation before breakage of 625%.

     The FDA reviews U.S. company records and spot checks batches for cracking, molding,
     drying, or sticking latex. The organization also tests every lot of imported condoms. Upon      sampling, lots will not pass inspection if they reveal greater than 4% failure with respect to
     the above dimensions, 2.5% failure with respect to tensile strength and elongation, and
     0.4% failure due to leakage.