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510(k) Data Aggregation
K Number
K153016Device Name
aoni Natural Rubber Latex Condom
Manufacturer
Date Cleared
2016-10-20
(371 days)
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Daming United Rubber Products Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
aoni Natural Rubber Latex Condom [Smooth/Dotted/Combined]
a) Smooth 52mm/54mm/55mm natural
b) Dotted 52mm natural
c) Combined [smooth+girdling] 52mm natural
d) Combined [dotted+girdling] 52mm natural
The Condom is used for contraception and for prophylactic purpose ( to help prevent pregnancy and the transmission of sexually transmitted infections.)
Device Description
aoni Natural Rubber Latex Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These condoms conform to ISO 4074:2002 Natural Rubber Latex Condoms – Requirements and Test Methods, ASTM D3492-14 Standard Specification for Rubber Contraceptives (Male Condom), and ISO 10993-1 Biological Evaluation of Medical Devices - Part 1(2009). These condoms have repeated contact potential for a duration of <24 hours and contact the mucosal membrane. They are for home use.
aoni Natural Rubber Latex Condom include four types as following:
[Smooth]: aoni Natural rubber latex condom [Smooth] are straight walled bulbous ended with smooth surface, having a nominal length of 180mm, a nominal width of 52mm/54mm/55mm, a nominal thickness of 0.036-0.080mm, Natural color
[Dotted]: aoni Natural rubber latex condom [Dotted] are straight walled bulbous ended with Dotted surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.
[Combined: (smooth+girdling)]: aoni Natural rubber latex condom [Combined: (smooth+girdling)] are girdling walled bulbous ended with smooth surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.
[Combined: (dotted+girdling)]: aoni Natural rubber latex condom [Combined: (dotted+girdling)] are girdling walled bulbous ended with dotted surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.
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