Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

K213400 · Rb Health (Us) · NUC · Mar 1, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K213400
• Device Name: Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
• Applicant: Rb Health (Us)
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants 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. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

Device Story

Water-based personal lubricants; applied topically to penile, vaginal, or anal areas to moisturize and lubricate during sexual activity. Used OTC by consumers. Supplements natural lubrication; enhances comfort. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Packaged in PET or HDPE bottles with PP caps. Benefits include reduced friction and increased comfort during intimate activity.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, vaginal irritation, sensitization, acute systemic toxicity) confirmed non-cytotoxic, non-irritating, non-sensitizing, and non-toxic. Condom compatibility tested per ASTM D7661-10. Shelf-life validated via accelerated aging per ASTM F1980-16.

Technological Characteristics

Water-based gel; ingredients include water, propylene glycol, xanthan gum, carbomer, benzoic acid, sodium hydroxide, sodium saccharin, and flavor. Packaged in PET/HDPE bottles. Non-sterile. Shelf-life 1.5-2 years. Tested per ASTM F1980-16 (aging), ASTM D7661-10 (condom compatibility), and ISO 10993 series (biocompatibility).

Indications for Use

Indicated for individuals requiring personal lubrication for penile, vaginal, and/or anal application to moisturize and enhance comfort during sexual activity. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.

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

• Grosz Play Feel (K211088)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 1, 2022

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

Re: K213400

Trade/Device Name: Grosz Play Aloe, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 19, 2022 Received: January 27, 2022

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,

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) K213400

#### Device Name

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

Indications for Use (Describe)

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants 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. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510K Summary K213400

### Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

| Submitted by: | RB Health (US) LLC<br>399 Interpace Parkway<br>Parsippany NJ 07054-0224<br>973-404-2715 |
|----------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa Burns<br>Regulatory Sr.<br>Manager RB<br>Health (US) LLC<br>862-325-0012 |
| Date Prepared: | February 25, 2022 |
| Device/Trade Name: | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry,<br>Grosz Play Strawberry |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Regulatory Class: | II |
| Predicate Device(s): | Grosz Play Feel |
| Device Name: | RB Health (US) LLC |
| Manufacturer: | K211088 |
| 510(k) Number: | |

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

### Description of the Device:

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are water-based personal lubricants 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. The products are compatible with natural rubber latex and polyisoprene condoms. The products are not compatible with polyurethane condoms. They are for over-the-counter (OTC) use. The formula consists of water, propylene glycol. xanthan gum, carbomer, benzoic acid, sodium hydroxide, sodium saccharin and flavor. Grosz Play Aloe, Grosz Play Ylang, and Grosz Play Guarana are packaged in a 200 mL polyethylene terephthalate (PET) bottle fitted with a polypropylene (PP) cap. Grosz Play Cherry and Grosz Play Strawberry are packaged in a 50 mL high density polyethylene (HDPE) bottle fitted with a polypropylene (PP) cap. The bottle and cap feature a tamper evident shrink seal label. The

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individual bottles may be packaged in an outer cardboard carton.

#### Subject Device Specifications:

| Specification | ALOE | YLANG | GUARANA | CHERRY | STRAW-<br>BERRY |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Appearance | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter | Colorless, transparent gel, free from lumps and particulate matter | Colorless, transparent gel, free from lumps and particulate matter |
| Odor | No objectional odor | No objectional odor | No objectional odor | Characteristic of cherry | Characteristic of strawberry |
| Viscosity (cps) | 3,300 - 10,000 | 3,300 - 10,000 | 3,300 - 10,000 | 3,400 - 10,000 | 3,400 - 10,000 |
| Osmolality (mOsm/kg) | 695 - 1,095 | 720 - 1,120 | 710 - 1,110 | 683-1,083 | 742 - 1,143 |
| Benzoic Acid | 0.15-0.22 %w/w | 0.15-0.22 %w/w | 0.15-0.22 %w/w | 0.15-0.22 %w/w | 0.15-0.22 %w/w |
| pH at 25°C | 3.5 - 4.5 | 3.5 - 4.5 | 3.5 - 4.5 | 3.5 - 4.5 | 3.5 - 4.5 |
| Total Yeast and Mold<br>Count (TYMC)* | < 10 cfu/g | < 10 cfu/g | < 10 cfu/g | < 10 cfu/g | < 10 cfu/g |
| Total Aerobic Microbial<br>Count (TAMC)* | < 100 cfu/g | < 100 cfu/g | < 100 cfu/g | < 100 cfu/g | < 100 cfu/g |
| Total Specified Organisms | per EP 10.0 Section: 2.6.13* | per EP 10.0 Section: 2.6.13* | per EP 10.0 Section: 2.6.13* | per EP 10.0 Section: 2.6.13* | per EP 10.0 Section: 2.6.13* |
| Pseudomonas aeruginosa | Absent | Absent | Absent | Absent | Absent |
| Staphylococcus aureus | Absent | Absent | Absent | Absent | Absent |
| Candida albicans | Absent | Absent | Absent | Absent | Absent |
| Escherichia coli | Absent | Absent | Absent | Absent | Absent |
| Preservative Effectiveness<br>Testing | PET, per EP 10.0 Section: 5.1.3* | PET, per EP 10.0 Section: 5.1.3* | PET, per EP 10.0 Section: 5.1.3* | PET, per EP 10.0 Section: 5.1.3* | PET, per EP 10.0 Section: 5.1.3* |
| Escherichia coli,<br>Pseudomonas aeruginosa,<br>Staphylococcus aureus | NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days | NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days | NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days | NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days | NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days |
| Candida albicans,<br>Aspergillus niger (A.<br>brasiliensis) | 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days | 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days | 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days | 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days | 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days |

* European Pharmacopoeia (EP) standards EP 10.0 Sections 2.6.12, 2.6.13, and 5.1.3 have harmonized with or have comparable specifications to USP standards USP <61>, and <51>, respectively.

Indications for Use Statement: Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants 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. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

Comparison of Intended Use and Technological Characteristics with the Predicate Device: A comparison of the technological features of the subject and predicate devices is provided in the table below:

| 510(k) | K2134000<br>Subject Device | K211088<br>Predicate Device |
|-------------|--------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | Grosz Play Aloe, Grosz Play<br>Ylang, Grosz Play Guarana,<br>Grosz Play Cherry, Grosz Play | Grosz Play Feel |

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| | Strawberry | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Grosz Play Aloe, Grosz Play Ylang,<br>Grosz Play Guarana, Grosz Play Cherry,<br>and Grosz Play Strawberry are personal<br>lubricants intended for penile, vaginal<br>and/or anal application to moisturize and<br>lubricate, to enhance the ease and<br>comfort of intimate sexual activity and<br>supplement the body's natural<br>lubrication. They are compatible with<br>natural rubber latex and polyisoprene<br>condoms. They are not compatible with<br>polyurethane condoms. | Grosz Play Feel is intended for penile,<br>vaginal and/or anal application to<br>moisturize and lubricate, to enhance<br>the ease and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. Grosz Play Feel is<br>compatible with natural rubber latex<br>and polyisoprene condoms. Grosz Play<br>Feel is not compatible with<br>polyurethane condoms. |
| Rx/OTC | OTC | OTC |
| Physical<br>Features | Homogenous transparent gel | Homogeneous clear gel |
| Base Type | Water | Water |
| Sterile | No | No |
| Primary<br>Ingredients | Water, Propylene Glycol, Xanthan<br>Gum, Carbomer, Benzoic Acid,<br>Sodium Hydroxide, Sodium<br>Saccharin, Flavor. | Water, Propylene Glycol, Xanthan Gum,<br>Carbomer, Benzoic Acid, Sodium<br>Hydroxide. |
| Biocompatibility<br>Tested | Yes | Yes |
| Antimicrobial<br>Tested | Yes | Yes |
| Condom<br>Compatibility | Compatible with natural rubber latex<br>and polyisoprene condoms. Not<br>compatible with polyurethane condoms. | Compatible with natural rubber latex<br>and polyisoprene condoms. Not<br>compatible with polyurethane condoms. |
| Shelf Life | Grosz Play Aloe, Grosz Play<br>Cherry, Grosz Play Strawberry: 2<br>years<br>Grosz Play Ylang, Grosz Play<br>Guarana: 1.5 years | 2.5 years |

The subject and predicate device have identical indications for use statements and have the same intended use.

The subject device and predicate devices have different technological characteristics, including different formulations and shelf-life. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

## Summary of Performance Testing:

Shelf life: Grosz Play Aloe, Grosz Play Cherry, and Grosz Play Strawberry have a proposed shelf-life of 2 years (24 months). Grosz Play Ylang and Grosz Play Guarana have a proposed shelf-life of 1.5 years (18 months). All device specifications listed in the device specifications table above were tested based on accelerated aging conditions per ASTM F1980-16. Results from testing demonstrated that the device can maintain its specifications over the duration of its shelf life

Biocompatibility: Biocompatibility studies were performed for all variants of the subject device in

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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" and ISO 10993- 1:2009 as follows:

- Cytotoxicity (ISO 10993-5: 2009)
- . Vaginal Irritation (ISO 10993-10: 2010)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010) ●
- Acute Systemic Toxicity (ISO 10993-11: 2006) ●

The results of this testing demonstrated that the subject lubricants are non-cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.

Condom Compatibility: Grosz Play Aloe, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. It was determined not to be compatible with polyurethane condoms.

Conclusion: The results of the performance testing described above demonstrate that the Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry is as safe and effective as the predicate device and supports a determination of substantial equivalence.