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The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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This document is a 510(k) clearance letter from the FDA for a medical device:

• Device Name: Ultra Thin Latex Condom with Silicone Lubricant
• Applicant: INNOLATEX SDN. BHD.
• Date of Letter: November 9, 2001
• FDA Product Code: 85 HIS
• Regulation Number: 21 CFR 884.5300
• Regulation Name: Condom

Based on the provided text, there is no information regarding acceptance criteria for device performance, any specific study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type of ground truth used.

The document is a regulatory clearance letter stating that the device is substantially equivalent to a legally marketed predicate device. It discusses general controls, additional controls for Class II/III devices, good manufacturing practices, labeling requirements (including expiration dating for latex condoms), and contact information for regulatory inquiries.

The "INDICATIONS FOR USE STATEMENT" at the end confirms that the "Male Natural Rubber Latex Condom" (with no particular brand name specified in the provided text in that section) is indicated for contraception and prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted diseases).

Therefore, I cannot provide the requested information as it is not present in the given document.

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