Condom

Model NO.: 180mm, 52mm
Model NO.: 180mm, 52mm
  1. SUMMARY
 
    1. PRODUCT INSTRUCTION
The condom is made by steps of triple dipping, drying, and further vulcanization  using pure natural latex rubber that imported from Thailand or Malaysia. There's a latex ring at the open-ended and a teat at the closed end. Between these two ends, it's latex thin film condom, the surface includes Smooth and Non-Smooth.
The condom uses food grade silicone oil as lubricant. And it has a single sealed package.
All the condoms passed by 100% individually electronically test. The use of it is contraception or preventing sexually transmitted diseases and AIDS by isolating body fluid contact.
 
  1. 2 PRODUCT PERFORMANCE AND REQUIREMENTS
The bursting pressure of single condom(before aging\after aging) ≥ 1.0kpa. The bursting volume of single condom(before aging\after aging) ≥ 18.0dm³, unqualified number of each lot must be controlled within the acceptable range.
The pinhole can not be found visible or invisible on a single condom, the unqualified number of pinhole of each lot must be controlled within the acceptable range.
The single condom can not have serious visible defects, the unqualified number of visible defects product of each lot must be controlled within the acceptable range.
Package integrity shall be measured according to the following protocol using a vacuum level corresponding to (20 ± 5) kPa absolute pressure. The unqualified number of packaging integrity of each lot must be controlled within the acceptable range.
The size of single product is allowable in nominal value range. The unqualified number of each lot must be controlled within the acceptable range.
The result of Intracutaneous, In Vitro Cytotoxicity and Maximization Sensitization Study must be accordance with biological evaluation standard of medical apparatus and instruments.
The single condom should has appropriate penis size, without pinhole, and has  enough physical strength that insure it won't break in use. It should have a appropriate packaging for protecting the product in it.
In the process of normal storage or use, the condom and any lubricant, additive, dressing, packing material or powders in the production process should neither  contain nor release enough toxicity, allergies, local irritation or Other hazards.
 
  1. 3 HOW TO USE
  2. (1)Carefully open the package so the condom does not tear. Do not use the teeth or a sharp object to open the package. Do not unroll the condom before putting it on.
  3. (2)Pinching the tip of the condom to squeeze out air, roll on the condom until it reaches the base of the penis. If the condom is initially placed on the penis backwards, do not turn it around. Throw it away and start with a new one.
  4. (3)After ejaculation, hold onto the condom at the base of the penis. Keeping the condom on, pull the penis out before it gets soft. Slide the condom off without spilling the liquid(semen) inside. Throw away the used condom.
  5. (4)The product dose not include spermicide, but have silicone oil lubricant. If you want to use other lubricant, please use the correct type of recommendation, avoid using petroleum base lubricant, such as vaseline, baby oil, bath foam, massage oil, butter, oleomargarine etc. Because these oil can destroy the condom.
  6. (5)Please consult doctor or pharmacist about the applicable drug for touching condom.
 
  1. 4 OBJECTS OF RISK MANAGEMENT
The risk management of whole process of manufacturing of Natural Latex Rubber Condom and during it's storage period.
 
  1. 5 PURPOSE OF RISK MANAGEMENT
The use of any medical devices will cause some risks. We should always keep the safety and effectiveness of the medical equipment products by managing the risks during the production process and the shelf life, taking effective risk control measures for reducing the risk to an acceptable level.

2. CRITERION OF RISK ASSESSMENT

2.1 THE CLASSIFICATION OF RISK SEVERITY
The classification of
severity 		Description Illustrate
S1 Unconspicuous Few or no potential damage No bad reaction
S2 Slight Cause slight injury Slight bad reaction
S3 Serious Serious injury or death Serious anaphylaxis cause shock
or death
S4 Very serious A lot of death or serious injury Cause lots of death

2.2 THE CLASSIFICATION OF THE RISK PROBABILITY OF OCCURRENCE
Classification of harm probability Description
S6 Frequently It will happen one time in use of one hundred times
S5 Sometimes It will happen one time in use of one thousand times
S4 Occasional It will happen one time in use of ten thousand times
S3 Rarely It will happen one time in use of hundred thousand
times
S2 Rare occurrence It will happen one time in use of million of times
S1 Almost impossible It will happen one time in use of ten million times
 2.3 THE PRINCIPLE OF ACCEPTABLE RISK We'll divide the risk into three region as to harm severity and the probability of harm occurrence: unacceptable area(NAC), widely acceptable area(AC) and reasonable lower area(ALARP).


 
  1. SUMMARY
 
    1. PRODUCT INSTRUCTION
The condom is made by steps of triple dipping, drying, and further vulcanization  using pure natural latex rubber that imported from Thailand or Malaysia. There's a latex ring at the open-ended and a teat at the closed end. Between these two ends, it's latex thin film condom, the surface includes Smooth and Non-Smooth.
The condom uses food grade silicone oil as lubricant. And it has a single sealed package.
All the condoms passed by 100% individually electronically test. The use of it is contraception or preventing sexually transmitted diseases and AIDS by isolating body fluid contact.
 
  1. 2 PRODUCT PERFORMANCE AND REQUIREMENTS
The bursting pressure of single condom(before aging\after aging) ≥ 1.0kpa. The bursting volume of single condom(before aging\after aging) ≥ 18.0dm³, unqualified number of each lot must be controlled within the acceptable range.
The pinhole can not be found visible or invisible on a single condom, the unqualified number of pinhole of each lot must be controlled within the acceptable range.
The single condom can not have serious visible defects, the unqualified number of visible defects product of each lot must be controlled within the acceptable range.
Package integrity shall be measured according to the following protocol using a vacuum level corresponding to (20 ± 5) kPa absolute pressure. The unqualified number of packaging integrity of each lot must be controlled within the acceptable range.
The size of single product is allowable in nominal value range. The unqualified number of each lot must be controlled within the acceptable range.
The result of Intracutaneous, In Vitro Cytotoxicity and Maximization Sensitization Study must be accordance with biological evaluation standard of medical apparatus and instruments.
The single condom should has appropriate penis size, without pinhole, and has  enough physical strength that insure it won't break in use. It should have a appropriate packaging for protecting the product in it.
In the process of normal storage or use, the condom and any lubricant, additive, dressing, packing material or powders in the production process should neither  contain nor release enough toxicity, allergies, local irritation or other hazards.
 
  1. 3 HOW TO USE
  2. (1)Carefully open the package so the condom does not tear. Do not use the teeth or a sharp object to open the package. Do not unroll the condom before putting it on.
  3. (2)Pinching the tip of the condom to squeeze out air, roll on the condom until it reaches the base of the penis. If the condom is initially placed on the penis backwards, do not turn it around. Throw it away and start with a new one.
  4. (3)After ejaculation, hold onto the condom at the base of the penis. Keeping the condom on, pull the penis out before it gets soft. Slide the condom off without spilling the liquid(semen) inside. Throw away the used condom.
  5. (4)The product dose not include spermicide, but have silicone oil lubricant. If you want to use other lubricant, please use the correct type of recommendation, avoid using petroleum base lubricant, such as vaseline, baby oil, bath foam, massage oil, butter, oleomargarine etc. Because these oil can destroy the condom.
  6. (5)Please consult doctor or pharmacist about the applicable drug for touching condom.
 
  1. 4 OBJECTS OF RISK MANAGEMENT
The risk management of whole process of manufacturing of Natural Latex Rubber Condom and during it's storage period.
 
  1. 5 PURPOSE OF RISK MANAGEMENT
The use of any medical devices will cause some risks. We should always keep the safety and effectiveness of the medical equipment products by managing the risks during the production process and the shelf life, taking effective risk control measures for reducing the risk to an acceptable level.

2. CRITERION OF RISK ASSESSMENT

2.1 THE CLASSIFICATION OF RISK SEVERITY
The classification of
severity 		Description Illustrate
S1 Unconspicuous Few or no potential damage No bad reaction
S2 Slight Cause slight injury Slight bad reaction
S3 Serious Serious injury or death Serious anaphylaxis cause shock
or death
S4 Very serious A lot of death or serious injury Cause lots of death

2.2 THE CLASSIFICATION OF THE RISK PROBABILITY OF OCCURRENCE
Classification of harm probability Description
S6 Frequently It will happen one time in use of one hundred times
S5 Sometimes It will happen one time in use of one thousand times
S4 Occasional It will happen one time in use of ten thousand times
S3 Rarely It will happen one time in use of hundred thousand
times
S2 Rare occurrence It will happen one time in use of million of times
S1 Almost impossible It will happen one time in use of ten million times
 2.3 THE PRINCIPLE OF ACCEPTABLE RISK We'll divide the risk into three region as to harm severity and the probability of harm occurrence: unacceptable area(NAC), widely acceptable area(AC) and reasonable lower area(ALARP).


 

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