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510(k) Data Aggregation
K Number
K021186Device Name
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
Manufacturer
Date Cleared
2002-10-25
(193 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
CONDOMI ERFERT PRODOKTIONSGESELLSCHAFT MBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Condomi brand latex condoms are intended to be used as a contraceptive (for the prevention of pregnancy) and/or for the prevention of the transmission of sexually transmitted diseases.
Device Description
Like other natural latex condoms on the market, the Condomi brand condoms are latex sheaths, which completely cover the penis with a closely fitting membrane. The following condom styles, colors, and flavors will be offered:
a) Standard transparent lubricated with silicon oil
b) Colored pink, studded, lubricated with silicon oil
c) Colored gold, lubricated with silicon oil, and vanilla flavor.
d) Transparent, form-fitting condom, lubricated with spermicidal lubricant N-9
e) Extra large condom transparent, lubricated with silicon oil
f) Extra strong condom, transparent, lubricated with silicon oil
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