(89 days)
Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal 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.
Astroglide® X Silicone Personal Lubricant is non-sterile, clear, odorless, and siliconebased lubricant. This product is not a spermicide or contraceptive. Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms. Astroglide® X Silicone Personal Lubricant is not compatible with polyurethane, or polyisoprene condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is packaged in a cardboard carton which constitutes the final packaging.
The provided text describes the acceptance criteria and a study for the Astroglide® X Silicone Personal Lubricant.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Clear | Clear |
| Odor | Characteristic | Odorless |
| Viscosity | 225 to 350 centipoise | 225 to 350 centipoise |
| Total yeast/mold count (USP ) | ) | ) |
| Water activity (USP) |
§ 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.