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Cpg sec.345.100 condoms defects - criteria for direct reference seizer section: specimen charges point 2: if the condoms are labeled for the prevention of disease, also charge."that the article of device is misbranded within the meaning of the act, 21 u.S.C.352(a), in that its labeling for the prevention of disease" is false "or" misleading, because the article contains holes." condom / labels: not concerning leakage are holes.My name is (b)(6).My phone number is (b)(6).After reading a brief online assessment on single use internal condoms, i became concerned with the labeling.I want to inform the fda that i know of a male and a female who are both (b)(6) and they use condoms to transmit their (b)(6) strain.The problem with the single use external condoms is if a male uses a condom and he is hiv-positive and he has sex with two other female, one female being hiv- positive and one female being hiv negative, and the male use the condom and has sex with both females at the same time and the male has sex with the hiv-positive female first and then has sex with the hiv-negative female second.The one who is negative now becomes infected with hiv using an external male condom because the virus is now on the external part of the external male condom.Another situation is if there are two males and a female having sex using an external male condom, the male is hiv positive and he's having sex with hiv-positive male and a negative hiv female, the female is now infected with hiv from an external male condom because he uses the condom on the male and then he inserts the same condom to the female vaginal area.I am not sure if the labeling is the fault of the condom company or at fault of the fda, however, i do want to inform someone that citizens of the united states of america are being infected with hiv while using condoms the standard specs for rubber contraception the specimen charge says that condoms are labeled for the prevention of disease.Now if we have citizens out here who know that they are hiv-positive and choose to use a condom when they are sexually active because they are legally obligated to because of their sexual status being positive and are being mischievous and very deceitful spreading their strain of hiv using a condom.I want you to know that some of our citizens don't understand or know where they got hiv from if they do not report partners who they use condoms with.I say that to say this i do not have (b)(6) so i do not know the procedures; however, we know that you can get hiv from having unprotected sex so if a male or a female become hiv-positive and they do not tell the dr or whoever assesses them after becoming hiv positive that they had sex with this male or that female because they are thinking they could not have gotten hiv from someone they used a condom with this can be a great concern and very life threatening.I am concerned that i know it may not be an issue of the condom company brand or the fda, however condoms are single-use (external and internal), however, if people feel that they are protecting themselves from stds, stis, and hiv by having sexual encounters using a condom and now knowing that people can get hiv using condoms.I wanted to know what the united states is going to do about promoting safer sex using protection (contraception) condoms.Addressing the labeling issue on external and internal condoms is that you guys do say that they are labeled to prevent disease; however, i think that there should be some type of labeling to help make it pertinent that condoms are single-use and that if people are in polyamorous sexual relationships that they should use one condom whether its internal or external per sexual partner whether it is male on male or female on female, this is not discriminating against sexual orientation or the sex of our citizens.It's just a safety measure.Does hiv or any std or sti die when exposed to air? pls call (b)(6).If an fda rep can give me a call at (b)(6), it'll be greatly appreciated it.I am concerned with citizens who do not understand that they may have become hiv-positive using a condom.Because hiv is a very private matter between the citizen in the citizen's sexual partners i want to be someone who speaks up so people can be aware that that is possible.I am not a scientist, however if you all know that that is impossible to transmit stds, stis, and hiv using a condom for sure then this is just a frivolous complaint.However i'm not sure if you all know of anything like this happening or ever heard of anything like this.I experienced something in the year of 2019 that i became very uncomfortable with which is why i'm reaching out and making a complaint or report.If labeling is not the problem of the fda or of the condom company, will you all still reach out to me know what would be a better solution.I am also reaching out because if people who are infected with hiv have to report their sexual partners and they mistakenly or do not report partners that they have had sexual relationships with using a condom that can also be a life threatening hazard because then the person who is out here transmitting the hiv has not been reported.The picture i attached does say that condoms reduce the transmission, however, it also states that there is barrier between the infection and the private part.If the barrier meaning the external male condom is no longer safe since it is 2019 and people are polyamorous and use condoms and it's not against the law; how do we make the barrier of an external male condom safe? if someone will give me a call or someone can reach me at my email: (b)(6) to talk about the experience then i can better explain in detail exactly why i feel like external male condoms protect against stds, stis and hiv.(b)(6).Fda safety report id# (b)(4).
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