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510(k) Data Aggregation
K Number
K162919Device Name
Male Latex Condoms
Manufacturer
Zhejiang Xiangban Latex Products Co., Ltd.
Date Cleared
2017-03-07
(140 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Xiangban Latex Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Latex Condom for Men is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Device Description
The Latex Condom for Men is a single-use, non-sterile condom made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms have either a smooth, dotted, or ribbed surface and have a straight walled nipple-end (SWNE) style within ASTM standard specifications D3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54mm, and minimum thickness of 30μM.
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