(269 days)
Intended 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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.
Exsens Personal Lubricants are non-sterile, water-based personal lubricants that provide personal lubrication during intimate sexual activity. They are made up of Glycerin, Water, Propylene Glycol, Aroma (Flavor), Aloe Barbadensis (aloe vera) leaf juice, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Sodium Saccharin and citric acid. The product is packaged in a 70ml polyethylene white tube with a flip-top cap and protective sleeve. It is for over-the-counter (OTC) use.
The document describes the acceptance criteria and performance data for Exsens Personal Lubricants. This information is presented in the context of a 510(k) premarket notification to the FDA, where the device is compared to a predicate device (K-Y Marilyn Pleasure Gel, K151884) to demonstrate substantial equivalence.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Exsens Personal Lubricant) |
|---|---|---|
| Appearance | Clear gel | Clear gel (Implicitly met as it's a characteristic, not a pass/fail test) |
| Odor | Neutral, mint, candy apple, raspberry | Neutral, mint, candy apple, raspberry (Implicitly met based on product description) |
| pH | 5.0 - 6.0 | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Viscosity | 7000 - 12,000 mPa | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Density | 1.14 | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Osmolality | 600 - 700 mOsmol/kg | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Antimicrobial Effectiveness | Meets acceptance criteria for Category 2 products | Met (Explicitly stated "Meets acceptance criteria for Category 2 products") |
| Total Microbial Count |
§ 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.