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CONDOMS


SPECIFICATIONS

1) MATERIALS

a) The Condoms, translucent in appearance, are made from the finest natural rubber latex and are free from embedded grit and discoloration. The condoms conform fully to the U.S. Code of Federal Regulations 21 CFR 1.
b) All Material for dressing and compounding purposes in use for manufacturing condom conform fully to the U.S. Code Federal Regulations 21 CFR1.

2) STANDARDS

Conforms to American Society for Testing and Materials D3492 and ISO 4074 in its entirety.

3) DESIGN

The condoms consist of cylindrical latex sheaths with one open end and the open end has thickened portion of latex contiguous with the sheath called ring. The ring shall remain intact and contiguous with the rest of the condom in all tests.

a) Wall Thickness

The wall thickness of condoms shall be measured at three points: 10 +/- 2mm from the open end, 30 +/- 5mm from the closed end, and the mid-distance between those two points. Lateral measurement made from the closed end shall exclude the reservoir tip. The individual measurements and the average of all three measurements shall be recorded for each condom.

Standard specifications

 : 0.65 +/- 0.015mm

Average single wall thickness

 : 0.06mm


b) Shape and Texture
The condoms are smooth-surfaced, straight and parallel sided, without constrictions.


i) Length
To conform to ISO 4074/2 and as per its testing procedures.

Standard specification

 : more than 190mm including teats

Average length

 : 195mm

ii) Width
To conform to ISO4074/3 and as per its testing procedures.

Standard specification

 : 52 +/- 2mm

Average length

 : 50mm

 

4) LUBRICATION

Silicone oil is used as lubricants in condoms

Standard specification : 250 mg to 500 mg
Average quantity of lubricant : 350mg


5) TENSILE PROPERTIES

To conform to ISO 4074/9 and as per its testing procedures.

Standard specification : Oven conditioning at 70 +/- 2 Deg C for 166 +/- 1 hours.
  BEFORE AFTER
Breaking load : Min 30 N Min 18 N
Elongation at break : Min 700% Min 650%

6) WATER LEAKAGE

Sampling in accordance to ISO 2859, general inspection Level 1, and to conform to ISO 4074/5 and as per its testing procedures.

Standard specification: General Inspection Level 1, AQL 0.4

7) AIR INFLATION TEST

Sampling in accordance to ISO 4074/6 and as per its testing procedures.

Standard specification:
Condoms shall not leak or burst at minimum bursting volume of no less than 15 DM3 at minimum bursting pressure of 0.9 kPa.

8) PACKAGE INTEGRITY

Condoms are sealed in individual packets constructed of a laminate with flexible metal foil and the packets are separated by perforations. The packets are also impermeable to light, air, ozone, and are able to protect the condoms during transportation and storage.

The external surface of the individual packets of condom is also free of lubricant.

9) PACKING SPECIFICATIONS

Each condom shall be individually packed and hermetically sealed in secure and rectangular foil after lubrication.

. 3 pieces pack - 3 peices in a box-pack, 3 x 48 packs in an outer box. 30 grams in a carton.
12 pieces pack - 12 peices in a box-pack, 12 x 12 packs in an outer box. 40 grams in a carton.

10) Quantity

Minimum 1 x 20" container per order
( 3 pieces pack - approximately 6500 gross in 1 x 20" container)
(12 peices pack - approximately 9000 gross in 1 x 20" container)

11) Payment

By unrestricted Irrevocable Letter of Credit at Sight and to be established within the Seven (7) days from the date of Confirmation of Trade.