(54 days)
Astroglide® Natural 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 ONLY compatible with natural rubber latex and polyisoprene condoms.
Astroglide Natural personal lubricant is non-sterile, clear and water based. Astroglide® Natural is a proprietary blend consisting mainly of water soluble ingredients similar to other lubricants currently on the market. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product primary packaging is a clear PET bottle with a screw on flip top cap comprised of polypropylene. Each bottle is packaged into a cardboard carton, which constitutes the device outer packaging.
The provided document is a 510(k) Summary for a medical device (personal lubricant) and does not contain information about the acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML-enabled medical device.
The document describes the "Astroglide Natural" personal lubricant and its substantial equivalence to a predicate device, "Glycerin and Paraben Free Astroglide." It outlines:
- Indications for Use: Moisturize and lubricate to enhance intimate sexual activity and compatible with natural rubber latex and polyisoprene condoms.
- Technological Characteristics: Comparison of ingredients, storage, pH, osmolarity, viscosity, and condom compatibility between the proposed device and the predicate.
- Biocompatibility Testing: Results of cytotoxicity, guinea pig maximization, vaginal irritation, penile irritation, and systemic toxicity tests.
- Specifications: Lot release specifications for quality control (color, clarity, odor, pH, viscosity, microbial counts).
- Shelf Life: 3 years based on real-time and accelerated aging studies.
- Condom Compatibility Testing: Tested with ASTM D7661-10, showing compatibility with latex and polyisoprene, but not polyurethane.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML-enabled medical device, as this document is for a personal lubricant and does not involve AI or ML.
§ 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.