Grosz Play Feel

K211088 · Rb Health (Us), LLC · NUC · Jul 9, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K211088
• Device Name: Grosz Play Feel
• Applicant: Rb Health (Us), LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Grosz Play Feel 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. Grosz Play Feel is compatible with natural rubber latex and polyisoprene condoms. Grosz Play Feel is not compatible with polyurethane condoms.

Device Story

Grosz Play Feel is a non-sterile, water-based personal lubricant intended for OTC use to moisturize and lubricate during intimate sexual activity. The device is applied topically by the user. It is formulated with water, propylene glycol, xanthan gum, carbomer, benzoic acid, and sodium hydroxide. The lubricant is packaged in 50 mL HDPE bottles with PP caps. It functions by providing a physical barrier and reducing friction during sexual activity. The device is compatible with natural rubber latex and polyisoprene condoms but not polyurethane condoms. It benefits the patient by enhancing comfort and supplementing natural lubrication.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity per ISO 10993), condom compatibility (ASTM D7661-10), and shelf-life stability (30 months).

Technological Characteristics

Water-based gel; ingredients: water, propylene glycol, xanthan gum, carbomer, benzoic acid, sodium hydroxide. Physical specs: viscosity 3,400-10,000 cPs, pH 3.5-4.5, osmolality 663-1,063 mOsm/kg. Packaging: HDPE bottle, PP cap. Tested per EP 8.0/USP standards for microbial limits and preservative effectiveness. Condom compatibility tested per ASTM D7661-10.

Indications for Use

Indicated for individuals requiring penile, vaginal, or anal lubrication to 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

• KY Banksy Aloe (K183302)

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 9, 2021

RB Health (US) LLC Elizabeth Viguerie Regulatory Manager 399 Interpace Parkway Parsippany, NJ 07054

Re: K211088

Trade/Device Name: Grosz Play Feel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 9, 2021 Received: April 12, 2021

Dear Elizabeth Viguerie:

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 -S

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) K211088

Device Name Grosz Play Feel

#### Indications for Use (Describe)

Grosz Play Feel 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. Grosz Play Feel is compatible with natural rubber latex and polyisoprene condoms. Grosz Play Feel is not compatible with polyurethane condoms.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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### K211088 Page 1 of 4

# 510(k) Summary K211088 Grosz Play Feel

#### 1. Submitter Information

| Applicant: | RB Health (US) LLC |
|------------|-------------------------------------------------|
| Address: | 399 Interpace Parkway Parsippany NJ, 07054-0224 |

#### 2. Correspondent Information

| Contact: | Elizabeth Viguerie,<br>Regulatory Manager |
|----------|----------------------------------------------------|
| Address: | 399 Interpace Parkway Parsippany NJ,<br>07054-0224 |
| Phone: | [phone] |
| Email: | [e-mail] |

#### 3. Date prepared: July 7, 2021

#### 4. Device Information

| Device Name: | Grosz Play Feel |
|--------------------|---------------------------|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | Class II |

#### 5. Predicate Device Information

| Device Name: | KY Banksy Aloe |
|----------------|--------------------|
| 510(k) Number: | K183302 |
| Manufacturer: | RB Health (US) LLC |

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

#### 6. Device Description

Grosz Play Feel is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene Glycol, Xanthan Gum, Carbomer, Benzoic Acid, and Sodium Hydroxide. Grosz Play feel is packaged in 50 mL bottles composed of High Density Polyethylene (HDPE) and fitted with a Polypropylene (PP) cap.

The bottle is packaged in an outer cardboard carton. Grosz Play Feel is a personal lubricant for over-thecounter (OTC) use. Device specifications are listed in Table 1 below.

#### Table 1: Device Specifications for Grosz Play Feel

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| Property | Specification |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Appearance | Viscous, clear gel |
| Odor | Odorless |
| Viscosity | 3,400 - 10,000 cPs |
| pH | 3.5 - 4.5 |
| Osmolality | 663 - 1,063 mOsm/kg |
| Total Yeast and Mold Count (TYMC, per EP 8.0 Section: 2.6.12)* | <100 cfu/g |
| Total Aerobic Microbial Count (TAMC, per EP 8.0 Section: 2.6.12)* | <10 cfu/g |
| Presence of Pathogens (per EP 8.0 Section: 2.6.13)* | Specification |
| Pseudomonas aeruginosa | Absent/g |
| Staphylococcus aureus | Absent/g |
| Candida albicans | Absent/g |
| Escherichia coli | Absent/g |
| Preservative Effectiveness Testing (PET, per EP 8.0 Section: 2.6.13)* | Specification |
| Escherichia coli, Pseudomonas aeruginosa,<br>Staphylococcus aureus | NLT 3.0 log reduction from the initial count at<br>7 days, and no increase from the 7 days' count<br>at 28 days |
| Candida albicans, Aspergillus niger (A. brasiliensis) | 2.0 log reduction from the initiation count at 14<br>days, and no increase from the 14 days' count<br>at 28 days |

*European Pharmacopoeia (EP) standards EP 8.0 Sections 2.6.12, 2.6.13, and 5.1.3 have harmonized with or have comparable specifications to USP standards USP <61>, <62>, and <51>, respectively.

#### 7. Indications for Use

Grosz Play Feel 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. Grosz Play Feel is compatible with natural rubber latex and polyisoprene condoms. Grosz Play Feel is not compatible with polyurethane condoms.

#### 8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below compares the intended use and technological characteristics of the subject and predicate device.

#### Table 2: Comparator Table for Subject and Predicate Device

| | Grosz Play Feel<br>K211088<br>Subject Device | KY Banksy Aloe<br>K183302<br>Predicate Device |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Indications for Use | Grosz Play Feel is intended for penile,<br>vaginal and/or anal application to<br>moisturize and lubricate, to enhance the<br>ease and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. | This product is intended for penile,<br>vaginal and/or anal application to<br>moisturize and lubricate, to enhance<br>the ease and comfort of intimate<br>sexual activity and supplement the<br>body's natural lubrication. |

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| | Grosz Play Feel is compatible with<br>natural rubber latex and polyisoprene<br>condoms. Grosz Play Feel is not<br>compatible with polyurethane condoms | This product is compatible with<br>natural rubber latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Features | Homogeneous Clear Gel | Homogeneous Clear Gel |
| Base type | Water | Water |
| Primary ingredients | Water, Propylene Glycol, Xanthan Gum,<br>Carbomer, Benzoic Acid, and Sodium<br>Hydroxide | Water, Propanediol, Xanthan Gum,<br>Benzoic Acid, Aloe Barbadensis Leaf<br>Juice, Potassium Lactate, Lactic Acid |
| Rx/OTC | OTC | OTC |
| Sterile | No | No |
| Condom Compatibility | Compatible with natural rubber latex and<br>polyisoprene | Compatible with natural rubber latex<br>and polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Effectiveness<br>Tested | Yes | Yes |
| Shelf life | 2.5 years | 2 years |

The subject and predicate device indications for use have a minor difference in wording; however, the intended use of the subject and predicate devices is the same (i.e., provides lubrication during intimate sexual activity).

The subject and predicate device have different technological characteristics included a different formulation and different shelf life as shown in the table above. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

#### 9. Summary of Non-Clinical Performance Testing

#### Biocompatibility

Biocompatibility studies were performed in accordance with the 2020FDA 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)
- 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 Grosz Play Feel is non-cytotoxic, non-irritating, nonsensitizing, and non-systemically toxic.

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### Shelf-Life

The subject device has a shelf-life of 30-months. Results from accelerated testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf-life.

#### Condom Compatibility

Grosz Play Feel 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.

#### 10. Conclusion

The results of the performance testing described above demonstrate that Grosz Play Feel is as safe and effective as the predicate device and supports a determination of substantial equivalence.