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Sagami Original 002 Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

The Sagami Original 002 Polyurethane Male Condom is made of a closely fitted sheath with a closed end, which completely covers the male penis with a non-latex, impermeable, non-sterile, fitted membrane made of a polyurethane material. Each device in the family is made of the same material: Polyurethane. All devices have a smooth-surface with a straight/parallel-walled shape, with a closed end that has a reservoir tip. Each device is lubricated with silicone oil ("dimethylpolysiloxane") and individually packaged. The Sagami Original 002 Condoms are a non-sterile, single use device. They are for home use and environments where persons have sexual activity. Based on currently available stability information, Sagami Original 002 Slim Fit and Sagami Original 002 Regular Mayer Labs have a 5 year shelf life and Sagami Original 002 Large has a 3 year shelf life.

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Water-based lubricant is a personal lubricant for penile, anal 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Water-based lubricant is a non-sterile, water-based personal lubricant for penile, anal 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Its formulation consists of purified water, 1,3-butanediol, propylene glycol, carbomer, glycerin, sodium hyaluronate, hydroxyethyl cellulose, sodium benzoate, sodium polyacrylate, citric acid, menthol, essence, and octyl hydroxamic acid.

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Chiavaye personal moisturizer is a 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. Chiavaye personal moisturizer is not compatible with natural rubber latex, polyurethane, or polyisoprene condoms.

Chiavaye Personal Moisturizer is a clear to slightly yellow and odorless oil-based personal lubricant that is not compatible with condoms made of natural rubber latex, polyisoprene, or polyurethane. This device is a non-sterile 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 device is sold as an over-the-counter (OTC) product in 30 mL and 100 mL sizes provided in black 'MIRON' glass, with a Polypropylene (PP) protective cap. The pump cap is made of Polypropylene (actuator), Nitrile (seal), and Polyethylene (tube).

The device is composed of Almond Oil, Coconut Oil, Grape Seed Oil, Sunflower Oil, Evening Primrose Oil, and Vitamin E.

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Hybrid personal lubricant (water&silicone) is a personal lubricant for penile, anal 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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Ceryne Intimate Care is a silicone-based personal lubricant for 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 compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Ceryne Intimate Care is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Its formulation consists of Dimethicone, Dimethiconol Silicone blend, 2-Octyldodecanol, Cholestrol, Span 60, Stearic Acid, Tocopheryl Acetate, Arlacel 165, Cetyl Stearyl Alcohol, Sodium Benzoate, Glycogen, L-Lactic Acid and Water. This device compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

The lubricant is packaged in 15g and 30g tubes.

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The Lifestyles® HydraFeel Natural Rubber Latex Condom is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

The LifeStyles® HydraFeel Natural Rubber Latex Condom is a single use condom made of natural rubber latex, featuring a straight-shaft, smooth-walled membrane that closely fits the penis. It acts as an barrier to prevent the transmission of sperm, bodily fluids, or STIs into the reproductive tract. The condom is coated with an aqueous lubricant and includes an integral bead at the open end for retention and a reservoir tip at the closed end to contain semen. The LifeStyles® HydraFeel Natural Rubber Latex Condom has a nominal length of 180 mm, width of 52 mm, and thickness of 0.045 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

The device conforms with all sections of consensus standards ISO 4074:2015, Natural rubber latex male condoms – Requirements and test methods, and ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms).

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Water-soluble Personal Lubricant is a water based personal lubricant, for penile 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. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant for penile 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. Its formulation consists of pure water, glycerin, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, sodium lactate, flavors, ethylenediaminetetraacetic acid, etc. The subject device includes four different flavors of water-soluble personal lubricants: Vitamin E flavor, Caramel flavor, Peach flavor, and Strawberry flavor. This device is not compatible with natural rubber latex, polyisoprene and polyurethane condoms.

The lubricant is packaged in PE bottles of 100gm.

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Plain water-based lubricant is a water-based lubricant intended for penile, vaginal and/or anal application 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, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Plain Water-based Lubricant

I'm sorry, I cannot fulfill this request. The provided document is an FDA 510(k) clearance letter for a "Plain Water-based Lubricant." This document is a regulatory communication from the FDA to the manufacturer, indicating that the device has been cleared for marketing.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study methodologies (such as MRMC studies or standalone performance). The letter focuses on regulatory compliance and substantial equivalence to a predicate device, not on detailed performance study results.

Therefore, I cannot extract the requested information about device performance and study details from the provided text.

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Water-based lubricant is intended for penile, vaginal and/or anal application to moisturize and lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubricant. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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The provided FDA 510(k) clearance letter for the "Water-based Lubricant" device (K250142) does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information but does not typically include the technical details of performance studies.

Therefore, I cannot extract the following information from the provided text:

1. Table of acceptance criteria and the reported device performance: This information is not present in the clearance letter.
2. Sample size used for the test set and the data provenance: This information is not present in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present in the clearance letter.
4. Adjudication method for the test set: This information is not present in the clearance letter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and any effect size: This information is not present in the clearance letter.
6. If a standalone (algorithm only) performance was done: This information is not present in the clearance letter.
7. The type of ground truth used: This information is not present in the clearance letter.
8. The sample size for the training set: This information is not present in the clearance letter.
9. How the ground truth for the training set was established: This information is not present in the clearance letter.

The clearance letter focuses on the regulatory determination of substantial equivalence, the device's classification, and general regulatory requirements, rather than the specifics of the performance testing. To obtain the requested information, one would need to refer to the actual 510(k) submission document filed by Global Protection Corp. for the Water-based Lubricant.

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The Natural rubber latex male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Natural rubber latex male condom

This document is a 510(k) clearance letter from the FDA for a Natural rubber latex male condom. It is not a document about an AI/ML medical device and therefore does not contain any information about acceptance criteria, study data, ground truth, or expert review related to AI/ML performance.

The provided text only addresses the regulatory clearance for a physical medical device (condom) based on substantial equivalence to a predicate device. It details the product name, regulation number, regulatory class, and indications for use. It also outlines general regulatory requirements such as quality system regulations, UDI, and adverse event reporting.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML device, as this information is not present in the provided document.

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