Oddway International, is the youngest of the group; exporting Natural Rubber Latex Male Condoms of smooth and various texture types with or without colors and flavors manufactured in state of the art Digital Technology plant having a Sophisticated Laboratory and R& D supports for all the customer demands related to the custom condom supply.
Oddway International has stirring realization of responsibilities of medical device exports; meeting, or could we say, exceeding International Standards is a way of life at Oddway Internaytional; and our products are Certified for ISO 9001:2000, ISO 13485:2003 and CE by DNV Norway, for Design, Export and Supply of Natural Rubber Latex Male Condoms.
Types of condoms we deal in :-
- Lubricated Condoms
- Non Lubricated Condoms
- Colored condoms: Palette of colors is available. Black, red, yellow, blue, green or any other color as per clients requirement.
- Flavored condoms: Varieties of flavors are available including strawberry, chocolate, peppermint, banana, and mango, Green Apple, Butter Scotch, Coffee and many more.
- Condoms with Benzocaine 4.5% (Climax Delay Condoms)
- Condoms with Aloe Vera
- Multi texture (3 in 1) Condoms (Dotted – Ribbed – Contour)
- Extra Thin Condoms
- Extra Strong condoms
- Warming Gel condoms
Custom Made Packing Options
- Option of providing disposable poly bags for proper dispose of condoms after use
- Tear Strip overwrapping of the inner cartons like cigarette wrapping
- Customs Design Packing material with MET/Spot UV/Drip off.
- Options of Variety of Packing Material
- 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.
- The basic Production Processes and primary equipment used for the manufacture of each variant of the device are exactly the same.
- All the variants of the device are tested using the same test equipment and test methods depending upon the applicable International Standard.
- 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
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).
QUALITY TESTING PROCEDURES
- Electrical Test
Each individual condom is subjected to an electrical test, where it is placed over a metal cylinder and checked for damage or production faults under high tension. This ensures that faulty specimens are discovered immediately and separated out accordingly. Spot endurance tests are also carried out on every production batch to ensure that quality standards are maintained.
- Volume Test
In the laboratory, the condom is filled with air until it bursts. To pass the test, the condom must have reached a CERTAIN volume, the minimum requirement is 18 lits of volume and 1.0 kpa pressure. Condoms are continually spot checked all the way through customs, FDA and to the final destination, always concerned that each box is perfect for you.
- 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.
- Oddway International, Exports products manufactured according to these standards, as per the customer’s requirements.
- 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.
- 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.
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.
For further information on the Product Pricing, Packing, Delivery, Terms & Conditions, please feel free to contact us.