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510(k) Data Aggregation
(89 days)
Astroglide X Silicone Personal Lubricant
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) |
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