SPERMICIDAL LUBRICATED MALE LATEX CONDOM

• K Number: K001377
• Device Name: SPERMICIDAL LUBRICATED MALE LATEX CONDOM
• Manufacturer: PLEASURE LATEX PRODUCTS SDN. BHD.
• Date Cleared: 2000-06-08 ( 38 days)
• Product Code: LTZ
• Regulation Number: 884.5310
• Type: Abbreviated
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 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).