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INTRODUCTION OF THE PRODUCTS

The Natural rubber latex male condom is used for contraception and for prophylactic purposes. (To help prevent pregnancy and the transmission of sexually transmitted diseases)

 

DESCRIPTION OF DEVICE

The condom is made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is almost cylindrical shape in length and includes a reservoir. The surface of the condom is smooth or textured (dotted or ribbed), translucent and may or may not be lubricated with silicone oil. This device is classified as Class IIb as per Rule 14 of annexure-IX of MDD 93/42/EEC (As explained at section 5.0)

 

DEVICE CHARACTERISTICS

  1. All the variants of the device are manufactured using the same raw materials including dressing materials and lubricant, however, excluding colours and flavours which are selectively used as per customers’ specifications.
  2. The basic Production Processes and primary equipment used for the manufacture of each variant of the device are exactly the same.
  3. All the variants of the device are tested using the same test equipment and test methods depending upon the applicable International Standard.
  4. To monitor the product characteristics various tests are conducted on the finished Product. “Finished Product Test Methods” have been established containing detailed procedure of testing (for further information please contact CLPL management). The test methods established are in compliance or exceed the requirements of various International standards applicable
 

INTENDED USE OF DEVICE

  1. Medical Function: Contraception and/or prevention against “Sexually Transmitted Diseases (STD’s)” including HIV infection under specified conditions of use.
  2. Mode of Operation: Condoms are worn over the erected penis before the later enters vagina or before commencing vaginal sexual intercourse.

 

DEVICE CLASSIFICATION

The Natural Rubber Latex Male Condoms have been classified as Class II b device in accordance with Rule 14 of Annex IX of the Medical Device Directive 93/42/EEC.

 

CONFORMITY ASSESSMENT PROCEDURE

We did the Conformity Assessment Procedure (CAP) in accordance with Annex II(excluding section 4 ): Full Quality Assurance (in compliance with EN 46001, ISO 13485:2003 and ISO 9001:2000) of the MDD 93/42/EEC. We are also meeting the ‘Essential Requirements’ as laid down in Annex I of the Directive (MDD 93/42/EEC).

 

General Information Concerning the Medical Device

 

DEVICE SPECIFICATIONS

  1. The device is well established and there are several published International and National Standards such as EN 4074:2002, ISO 4074:2002, ASTM D 3492, and WHO 2003 Specifications and Schedule –R of The Indian Drugs and Cosmetics Act, 1940.
  2. Convex Latex Pvt Ltd is manufacturing the device according to these standards, as per the customer’s requirements.
  3. Most of the International Standards or Specifications provide details about the properties of the device such as Dimensions, Burst Properties, Tensile Properties, Freedom from Holes and Lubricant Quantity, Labeling and Packaging Specifications or guidelines. In addition to the specifications, these standards also provide inspection level for sampling and AQL for each property individually. The sampling plans adopted by most of the standards are based on ISO 2859.
  4. Since the International Standards are mostly guidance documents, exact specifications, in particular, dimensions, labeling and packaging requirements depend largely on the customer or buyer’s requirements.

MATERIAL SPECIFICATIONS

The Raw Materials used in the manufacture of the device are Natural rubber Latex, Vulcanizing Agent, Accelerators, Dressing Materials, Lubricant, and several other chemical additives. The “Raw Material Specifications” in the controlled document contains detailed information on the materials (for further information please contact CLPL management).

We offer condoms made from premium quality latex material that helps to reduce the risk of unwanted pregnancy and Sexually Transmitted Diseases. Condoms are talc free and triple-tested to provide the highest quality and maximum reliability. Condoms are designed for the most natural sensation and maximum protection.

Our condoms are classified under four categories:

  • Plain condoms
    These are Plain and Natural Color condoms.Very thin but very strong provides ultra sensitivity.
  • Textured condoms
    Two types: Dotted and Ribbed condom
    The original ribbed condom with textured ribs to provide maximum sensation.All are lubricated for a comfortable natural feeling.Reservoir tip added for comfort and safety.
  • Flavored condoms
    A tempting assortment of flavors and colors for extra fun and excitement.Varieties of flavors are available, strawberry, peppermint, banana, and mang just to mention a few.All are lubricated for a comfortable, natural feeling.Reservoir tip added for comfort and safety.
  • Colored condoms
    Palette of colors is available.
    Black, red, yellow, blue, green or any other color you likeLubricated for a natural feeling.
    Spermicidal condoms contain the spermicidal Nonoxynol-9, which has been proven effective in killing sperm in lab tests, are available within all types.

Tips on Using Condoms:

  • First of all use condoms! Use a new condom before each sex act. Use only latex condoms. (Lambskin provides no protection from STDs.). Don't store condoms
    in a glove compartment or your wallet. Don't use them after the expiration date.
    Open the package carefully. Never open them with your teeth or using scissors.
    Make sure you can see what you are doing!
  • Put on a condom when the penis is erect, but before sexual penetrations. Put a few drops of water-based lubricant inside the tip of the condom. Never ever use oil based lubricant fat or greases such as petroleum jelly (like Vaseline) baby oils or lotion, hand or body lotions, cooking oils or oily cosmetics like cold cream on a latex condom. It will damage the effectiveness of the condom.
  • Squeeze the tip of the condom to leave some extra space and roll the rest down the shaft. If the penis is intact (has a foreskin), put the condom on with the foreskin pushed back. Once the shaft is covered, push the foreskin forward (toward the tip). This lets the foreskin move without breaking the condom. If the condom doesn't have a "reservoir end" squeeze tip of condom to remove air.
  • If you feel a condom break while having intercourse, stop and withdraw immediately.
  • After ejaculation, hold the condom close to the base of the penis and carefully withdraw.
  • For hygiene purposes, do dispose of your condoms properly and do not leave them lying around, especially if you have children or pets around the house. Wrap a used condom in a tissue and throw it in the trash. Don't flush them down the toilet. Condoms can choke the pipes if flushed down the toilet.

For further information on the Product Pricing, Packing, Delivery, Terms & Conditions, please feel free to contact us.

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