(234 days)
Karex's water based personal lubricant with flavors is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
Water Based Personal Lubricant with Flavors
- Vanilla
- Aloe Vera
- Strawberry
- Banana
- Peppermint
- Chocolate
This document is a 510(k) premarket notification decision letter from the FDA to Karex Industries Sdn. Bhd. for a "Water Based Personal Lubricant with Flavors." The letter states that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document pertains to a medical device approval for a lubricant, not a study evaluating an AI-powered diagnostic device. As such, the information requested for acceptance criteria and study details (e.g., test set, training set, expert consensus, MRMC studies) is not present in this document. The document primarily discusses regulatory compliance and the FDA's substantial equivalence determination for a physical product.
Therefore, I cannot provide the requested information based on the provided text. The document does not contain data or information about:
- A table of acceptance criteria and reported device performance for an AI/diagnostic device.
- Sample sizes, data provenance, ground truth establishment for test or training sets.
- Number and qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes for human readers.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
The text is about the regulatory approval of a personal lubricant.
§ 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.