MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR

• K Number: K023333
• Device Name: MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
• Manufacturer: PLEASURE LATEX PRODUCTS SDN. BHD.
• Date Cleared: 2003-06-23 ( 259 days)
• Product Code: HIS
• Regulation Number: 884.5300
• Type: Abbreviated
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

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).

Device Description

[No Particular Brand Name] Colored and/or Flavored Male Natural Rubber Latex Condom, 52mm or 56mm Nominal Width with Smooth or Dotted or Ribbed or 3 in 1 ( Dotted / Ribbed / Contoured) Surface Lubricated with Silicone Oil or Nonoxynol-9 Spermicide.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a conventional medical device (male latex condoms), not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies, standalone performance, ground truth for training data, etc.) is not applicable to this document.

The document discusses the substantial equivalence of the "Colored and Flavored Male Latex Condom (No Particular Brand Name)" to legally marketed predicate devices and mentions general controls provisions and specific labeling requirements for latex condoms (e.g., expiration dating per 21 CFR 801.435). However, it does not contain the kind of detailed study reports or performance metrics typically found for AI/ML device submissions.

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.