(85 days)
JO H2O Flavored Personal Lubricants are water-based personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
JO H2O Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
These products are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in polyester-faced laminated pouches.
The provided text is a 510(k) Premarket Notification from the FDA regarding "JO H2O Flavored Personal Lubricants." This document describes the device, its intended use, comparison to a predicate device, and performance data from various tests. However, it does not pertain to an AI/ML-enabled medical device or a study involving human readers and AI assistance. Therefore, I am unable to extract the specific information requested in the prompt regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML context.
The document discusses acceptance criteria and studies for a personal lubricant, focusing on:
- Biocompatibility: Acute Systemic Toxicity, Vaginal Irritation, Penile Irritation, Cytotoxicity, and Sensitization.
- Shelf-Life: Real-time aging study testing device specifications at 0, 1, 2, and 3 years.
- Condom Compatibility: Evaluation with different condom materials (natural rubber latex, polyisoprene, polyurethane) in accordance with ASTM D7661-10.
Without information specific to an AI/ML medical device, I cannot fulfill the request as formatted.
§ 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.