(1169 days)
Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.
The device in this 510(K) summary is a spermicidal lubricated condom. The condom will be sold under various trade names including Eros, Iris, Amoret, Galant, Gemini, Brillant, Casanova and Galla.
This document, K931220, describes a spermicidal lubricated condom and its specifications. It predates the widespread use of AI in medical device evaluation and therefore does not contain information related to AI/ML device performance or evaluation. The concepts of "acceptance criteria for an AI device," "test sets," "ground truth experts," "MRMC studies," or "standalone AI performance" are not applicable to the information provided.
Therefore, I cannot fulfill the request as it pertains to an AI/ML device. The provided text describes a traditional medical device (condom) and its compliance with established physical and manufacturing standards.
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SAFETY AND EFFECTIVENESS SUMMARY
AY 2 2 1996
Classification name : Condom (Rubber) Contraceptive
Classification Number : 85 HIS
Proprietary Name : The device in this 510(K) summary is a spermicidal lubricated condom. The condom will be sold under various trade names including Eros, Iris, Amoret, Galant, Gemini, Brillant, Casanova and Galla.
Intended Use and Performance Claim : Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.
Physical Composition : Condoms are manufactured from natural latex FA. The latex is purchased from traditional territories of type Malaysia and is of the highest quality which is tested according to ISO 2004.
Specifications : All specifications for these condoms meet or exceed all ASTM and ISO standards for condoms according to FDA requirements.
Safety Guidlines: When using a condom follow all instructions included with the condom. To assure that the condom will perform to its maximum quality level, follow this safety guideline:
Do Not Use the Condom If : The external package has visual signs of being tampered with, or shows physical damage possibly due to mishandling. The individual foil wrapping of the condom is damaged. The condom itself has damage (a tear or rip, is cracked or dried up any deformities as compared to a regular Spermicidal or has lubricated condom). Any other apparent damage that would cause a suspicion of the loss of integrity to the condom. The condoms should be stored in the cool and dry place.
§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).