Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine

K213892 · Rb Health (Us), LLC · NUC · Mar 7, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K213892
• Device Name: Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
• Applicant: Rb Health (Us), LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Grosz Warming Liquid is 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, polyisoprene and polyurethane condoms. Grosz Play Tingling is 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. Grosz KY Yours & Mine is 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.

Device Story

Personal lubricants for OTC use; intended to moisturize and lubricate during intimate sexual activity. Applied topically to penile, vaginal, or anal areas. Silicone-based (Grosz Warming Liquid, Grosz KY Yours) or water-based (Grosz Play Tingling, Grosz KY Mine) formulations. Packaged in HDPE or PET bottles. Enhances comfort by supplementing natural lubrication. User-applied; no clinical intervention required. Benefits include reduced friction and increased comfort during sexual activity.

Clinical Evidence

Bench testing only. Biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity per ISO 10993), antimicrobial effectiveness (USP 51), and condom compatibility (ASTM D7661-10) were performed. Shelf-life validated via accelerated and real-time aging.

Technological Characteristics

Silicone-based (Dimethicone, Sensate) or water-based (Water, Propylene Glycol, Carbomer, Xanthan Gum, Sensate, Benzoic Acid, Sodium Saccharin, Sodium Hydroxide) formulations. Non-sterile. Packaged in HDPE or PET bottles with polypropylene caps. Tested for viscosity (USP 912), pH (USP 791), and osmolality (USP 785).

Indications for Use

Indicated for penile, vaginal, and/or anal application to moisturize and lubricate to enhance comfort during intimate sexual activity and supplement natural lubrication. Compatible with specific condom types (natural rubber latex, polyisoprene, and/or polyurethane depending on product).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Swiss Navy Premium Silicone Lubricant and Swiss Navy Premium Water-Based Lubricant (K150153)

Submission Summary (Full Text)

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March 7, 2023

RB Health (US) LLC Lisa Burns Sr. Manager Regulatory Affairs 399 Interpace Parkway Parsippany, NJ 07054

Re: K213892

> Trade/Device Name: Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine Regulation Number: 21 CFR\$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 31, 2023 Received: February 3, 2023

Dear Lisa Burns:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael T. Bailey -S

For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K213892

#### Device Name

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine

#### Indications for Use (Describe)

Grosz Warming Liquid is 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, polyisoprene and polyurethane condoms.

Grosz Play Tingling is 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.

Grosz KY Yours & Mine is intended for penile, vaginal and/or anal application to mosturize 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary K213892

#### Grosz Warming Liquid, Grosz Play Tingling, and Grosz KY Yours & Mine

| 510(k) Owner: | RB Health (US) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address: | 399 Interpace Parkway, Parsippany, NJ 07054-0224 |
| Contact Person: | Lisa Burns |
| Contact Numbers: | 862-325-0012 |
| Summary Preparation Date: | March 1, 2023 |
| Trade Name: | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine |
| Common Name: | Personal Lubricant |
| Device Classification: | Regulation Name: Condom<br>Regulation Number: 21 CFR 884.5300<br>Product Code: NUC (lubricant, personal)<br>Device Class: Class II |
| Predicate Device: | Swiss Navy Premium Silicone Lubricant and Swiss Navy Premium<br>Water-Based Lubricant<br>510(k) Number: K150153<br>Manufacturer: Package Solutions LLC<br>Product Code: NUC<br>Device Class: Class II |

The predicate device has not been subject to a design-related recall.

### Device Description:

Grosz Warming Liquid is a non-sterile, silicone-based personal lubricant compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of Dimethicone and Sensate. Grosz Warming Liquid is packaged in a 30 mL high density polyethylene bottle (HDPE) mono layer and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Warming Liquid is a personal lubricant for over-the-counter (OTC) use.

Grosz Play Tingling is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene Glycol, Carbomer, Xanthan Gum, Sensate, Benzoic Acid, Sodium Saccharin, and Sodium Hydroxide. Grosz Play Tingling is packaged in a 50 mL HDPE bottle and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Play Tingling is a personal lubricant for OTC use.

Grosz KY Yours & Mine are two personal lubricants with the same formulations and specifications as Grosz Warming Liquid and Grosz Play Tingling, respectively, packaged together and compatible with natural rubber latex and polyisoprene condoms. Grosz KY Yours & Mine is not compatible with polyurethane condoms when used as intended. Grosz KY Yours and Grosz KY Mine are individual lubricants separately packaged in a 44 mL polyethylene terephthalate

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bottles and topped with a polypropylene cap and packaged together in a carton. Grosz KY Yours & Mine are for OTC use.

The device specifications are listed in the tables below:

Table 1 Grosz Warming Liquid and Grosz KY Yours

| Property | Specification |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Liquid |
| Color | Clear, Colorless |
| Odor | Odorless |
| Viscosity per <USP 912> | 70-110 cPs |
| Antimicrobial effectiveness per USP <51> | Bacteria: NLT 2.0 log reduction from the initial count at 14 days, and no increase from 14 days 'count at 28 days; Yeasts/Molds: No increase from the initial calculated count at 14 and 28 days. |
| Total aerobic microbial count (TAMC) per method equivalent to USP<61> | < 100 cfu/g |
| Total yeast and mold count (TYMC) per method equivalent to USP<61> | < 10 cfu/g |
| Presence of Pathogens per EP 8.0 Section: 2.6.13 | Specification |
| Pseudomonas aeruginosa | Absent/g |
| Staphylococcus aureus | Absent/g |
| Escherichia coli | Absent/g |
| Candida albicans | Absent/g |

## Table 2 Grosz Play Tingling and Grosz KY Mine

| Property | Specification |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Gel |
| Color | Transparent, Colorless |
| Odor | Very slightly acidic, no objectionable odor |
| Viscosity per USP <912> | 3,400 - 10,000 cPs |
| pH per USP <791> | 3.5 - 4.5 |
| Osmolality per USP<br><785> | 883-1,200 mOsm/kg |
| Antimicrobial<br>effectiveness per method<br>equivalent to USP<51> | Bacteria: NLT 3.0 log reduction from the initial count at 7 days, and<br>no increase from 7 days' count at 28 days; Yeasts/Molds: 2.0 log<br>reduction from the initial count at 14 days, and no increase from<br>the 14 days' count at 28 days. |
| Total aerobic microbial<br>count (TAMC) per<br>method equivalent to<br>USP<61> | < 100 cfu/g |

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| Total yeast and mold<br>count (TYMC) per<br>method equivalent to<br>USP<61> | < 10 cfu/g |
|-----------------------------------------------------------------------------|---------------|
| Presence of Pathogens<br>per method equivalent<br>to USP<62> | Specification |
| Pseudomonas aeruginosa | Absent/g |
| Staphylococcus aureus | Absent/g |
| Escherichia coli | Absent/g |
| Candida albicans | Absent/g |

## Indications for Use Statements:

Grosz Warming Liquid is 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, polyisoprene and polyurethane condoms.

Grosz Play Tingling is 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.

Grosz KY Yours & Mine is 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.

## Comparison of Intended Use and Technological Characteristics to the Predicate Device:

In the table below, the predicate for Grosz Warming Liquid and Grosz Yours is the Swiss Navy Premium Silicone Lubricant, while the predicate for Grosz Play Tingling and Grosz KY Mine is the Swiss Navy Premium Water Based Lubricant.

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| Feature | Grosz<br>Warming<br>Liquid<br>K213892 | Grosz Play<br>Tingling<br>K213892 | Grosz KY Yours &<br>Mine<br>K213892 | Swiss Navy Premium<br>[Silicone Lubricant<br>and Water-Based<br>Lubricant]<br>K150153 | Comments |
|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Grosz Warming<br>Liquid is<br>intended for<br>penile, vaginal<br>and/or anal<br>application to<br>moisturize and<br>lubricate, to<br>enhance the<br>ease and<br>comfort of<br>intimate sexual<br>activity and<br>supplement<br>the body's<br>natural<br>lubrication.<br>This product is<br>compatible<br>with natural<br>rubber latex,<br>polyisoprene<br>and<br>polyurethane<br>condoms. | Grosz Play Tingling is<br>intended for penile,<br>vaginal and/or anal<br>application to<br>moisturize and<br>lubricate, to<br>enhance the ease<br>and comfort of<br>intimate sexual<br>activity and<br>supplement the<br>body's natural<br>lubrication. This<br>product is<br>compatible with<br>natural rubber latex<br>and polyisoprene<br>condoms. This<br>product is not<br>compatible with<br>polyurethane<br>condoms. | Grosz KY Yours &<br>Mine is intended for<br>penile, vaginal and/or<br>anal application to<br>moisturize and<br>lubricate, to enhance<br>the ease and comfort<br>of intimate sexual<br>activity and<br>supplement the<br>body's natural<br>lubrication. This<br>product is compatible<br>with natural rubber<br>latex and<br>polyisoprene<br>condoms. This<br>product is not<br>compatible with<br>polyurethane<br>condoms. | The Swiss Navy<br>Premium Lubricants<br>are personal<br>lubricants for penile<br>and / or vaginal<br>application, intended<br>to moisturize and<br>lubricate, to enhance<br>the ease and comfort<br>of intimate sexual<br>activity and<br>supplement the<br>body's natural<br>lubrication. These<br>products are<br>compatible with<br>natural rubber latex<br>and polyisoprene<br>condoms. These<br>products are not<br>compatible with<br>polyurethane<br>condoms. | The indications for<br>use statements for<br>the subject and<br>predicate devices are<br>not identical, as the<br>subject devices are<br>also indicated for anal<br>use and have<br>differences in<br>condom<br>compatibility. These<br>differences do not<br>represent a new<br>intended use as both<br>the subject and<br>predicate devices are<br>intended to provide<br>lubrication to an<br>orifice with or<br>without use of<br>compatible condoms. |
| Base Type | Silicone | Water | Grosz KY Yours:<br>Silicone<br>Grosz KY Mine:<br>Water | Silicone Lubricant:<br>Silicone<br>Water-Based Lubricant:<br>Water | Same: The subject<br>devices and their<br>respective predicate<br>device have the same<br>base type. |
| Primary<br>ingredients | Dimethicone,<br>Sensate | Water,<br>Propylene<br>Glycol,<br>Carbomer,<br>Xanthan Gum,<br>Sensate,<br>Benzoic Acid,<br>Sodium<br>Saccharin,<br>Sodium<br>Hydroxide | Grosz KY Yours:<br>Dimethicone, Sensate<br>Grosz KY Mine:<br>Water,<br>Propylene<br>Glycol,<br>Carbomer,<br>Xanthan Gum,<br>Sensate, Benzoic<br>Acid, Sodium<br>Saccharin,<br>Sodium<br>Hydroxide | Not available | Differences in<br>formulations is not<br>known between Grosz<br>Warming Liquid/Grosz<br>KY Yours and the Swiss<br>Navy Premium Silicone<br>Lubricant or between<br>Grosz Play Tingling/Gros<br>KY Yours and the Swiss<br>Navy Premium Water<br>Based Lubricant.<br>Differences in<br>formulations do not<br>raise different<br>questions of safety |
| | | | | | |
| | | | | | and effectiveness<br>(S&E). |
| Over the counter<br>use | Yes | Yes | Yes | Yes | Same: The subject<br>devices and their<br>respective predicate<br>device are for OTC use. |
| Sterile | No | No | No | No | Same: The subject<br>devices and their<br>respective predicate<br>device are non-sterile. |
| Condom<br>Compatibility | Compatible with<br>natural rubber<br>latex and<br>polyisoprene<br>condoms and<br>polyurethane<br>condoms. | Compatible with<br>natural rubber<br>latex and<br>polyisoprene<br>condoms. Not<br>compatible with<br>polyurethane<br>condoms. | Compatible with<br>natural rubber latex<br>and polyisoprene<br>condoms. Not<br>compatible with<br>polyurethane<br>condoms. | These products are<br>compatible with natural<br>rubber latex and<br>polyisoprene condoms.<br>These products are not<br>compatible with<br>polyurethane<br>condoms. | Different: Condom<br>compatibility differs<br>between the subject<br>devices and their<br>respective predicate<br>device. Differences in<br>condom compatibility<br>does not raise different<br>questions of S&E. |
| Biocompatibility<br>Tested | Yes | Yes | Yes | Yes | Same: The subject<br>devices and their<br>respective predicate<br>device were tested and<br>shown to be<br>biocompatible. |
| Antimicrobial<br>Tested | Yes | Yes | Yes | Unknown | Differences in<br>antimicrobial testing is<br>not known between<br>Grosz Warming<br>Liquid/Grosz KY Yours<br>and the Swiss Navy<br>Premium Silicone<br>Lubricant or between<br>Grosz Play Tingling/Grosz<br>KY Yours and the Swiss<br>Navy Premium Water<br>Based Lubricant.<br>Differences in<br>antimicrobial<br>testing do not raise<br>different questions<br>of safety and<br>effectiveness (S&E). |
| Microbial Tested<br>(Total aerobic<br>microbial count,<br>total yeast and<br>mold count,<br>absence of<br>pathogens) | Yes | Yes | Yes | Yes | Same: The subject<br>devices and their<br>respective predicate<br>device completed this<br>testing. |
| pH Tested | No | Yes | Grosz KY Yours: No | Silicone Lubricant: No | Same: The subject<br>devices and their<br>respective predicate |
| | | | Grosz KY Mine: Yes | Water-Based Lubricant: Yes | device are the same regarding testing for this parameter. |
| Osmolality Tested | No | Yes | Grosz KY Yours: No | Silicone Lubricant: No | Same: The subject devices and their respective predicate device are the same regarding testing for this parameter. |
| Viscosity Tested | Yes | Yes | Yes | Yes | Same: The subject devices and their respective predicate device are the same regarding testing for this parameter. |

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As stated in the table, the indications for use for the subject and predicate devices are not identical, as the subject device is for anal, vaginal, and penile use, while the predicate device is only for vaginal and penile use. The addition of anal use for the subject device does not represent a new intended use, which is the same for both the subject and predicate devices (e.g., to provide lubrication during intimate sexual activity).

The subject and predicate devices have different technological characteristics. For example, different formulations. The different technological characteristics identified in the table do not raise different questions of safety and effectiveness.

### Summary of Performance Data:

### Biocompatibility

Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing were performed in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process", as follows:

- Cytotoxicity (ISO 10993-5:2009) ●
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)

The results of this testing demonstrated that the subject lubricants are biocompatible.

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## Shelf-Life:

The subject devices in this submission have the following shelf-life durations:

- Grosz Warming Liquid - 15 months
- Grosz Play Tingling 2 years ●
- Grosz KY Yours — 2 years
- Grosz KY Mine - 2 years

The shelf-life durations for the subject devices are based on the results of accelerated aging and real-time testing for Grosz Warming Liquid and Grosz KY Yours and accelerated aging testing for Grosz Play Tingling and Grosz KY Mine. All specifications for Grosz Warming Liquid/Grosz KY Yours and Grosz Play Tingling/Grosz KY Mine listed in Tables 1 and 2, respectively, were met throughout the shelf-life duration.

### Condom Compatibility:

The compatibility of the subject devices was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Grosz Warming Liquid was determined to be compatible with natural rubber latex, polyisoprene and polyurethane condoms. Grosz Play Tingling was determined to be compatible with natural rubber latex and polyisoprene condoms, and not compatible with polyurethane condoms. Grosz KY Yours & Mine when used together as intended, was determined to be compatible with natural rubber latex and polyisoprene condoms, and not compatible with polyurethane condoms.

## Conclusion:

The results of the performance testing described above demonstrate that Grosz Warming Liquid, Grosz Play Tingling, and Grosz KY Yours & Mine are as safe and effective as their respective predicate devices and support a determination of substantial equivalence.