(134 days)
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.
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 individual bottles may be packaged in an outer cardboard carton.
The document provided describes the acceptance criteria and performance of personal lubricants. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a personal lubricant, and the acceptance criteria are based on various physical, chemical, and microbiological specifications, as well as biocompatibility and condom compatibility. The performance data is reported as meeting these specifications.
| Specification | Acceptance Criteria | Reported Device Performance (all variants unless specified) |
|---|---|---|
| Physical/Chemical Specifications | ||
| Appearance | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter (for Aloe, Ylang, Guarana); Colorless, transparent gel, free from lumps and particulate matter (for Cherry, Strawberry) | Meets criteria |
| Odor | No objectional odor (for Aloe, Ylang, Guarana); Characteristic of cherry (for Cherry); Characteristic of strawberry (for Strawberry) | Meets criteria |
| Viscosity (cps) | 3,300 - 10,000 (for Aloe, Ylang, Guarana); 3,400 - 10,000 (for Cherry, Strawberry) | Meets criteria |
| Osmolality (mOsm/kg) | 695 - 1,095 (Aloe); 720 - 1,120 (Ylang); 710 - 1,110 (Guarana); 683-1,083 (Cherry); 742 - 1,143 (Strawberry) | Meets criteria |
| Benzoic Acid | 0.15-0.22 %w/w | Meets criteria |
| pH at 25°C | 3.5 - 4.5 | Meets criteria |
| Microbiological Specifications | ||
| Total Yeast and Mold Count (TYMC) | < 10 cfu/g | Meets criteria |
| Total Aerobic Microbial Count (TAMC) | < 100 cfu/g | Meets criteria |
| Total Specified Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli) | Absent | Meets criteria |
| Preservative Effectiveness Testing (PET) - Escherichia coli, Pseudomonas aeruginosa, 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 | Meets criteria |
| Preservative Effectiveness Testing (PET) - Candida albicans, Aspergillus niger (A. brasiliensis) | 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days | Meets criteria |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic | Determined to be non-cytotoxic |
| Vaginal Irritation | Non-irritating | Determined to be non-irritating |
| Sensitization | Non-sensitizing | Determined to be non-sensitizing |
| Acute Systemic Toxicity | Not systemically toxic | Determined to be not systemically toxic |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms | Determined to be compatible with natural rubber latex and polyisoprene condoms; Determined not to be compatible with polyurethane condoms |
| Shelf-Life | Maintain all specifications above for 2 years (Aloe, Cherry, Strawberry) or 1.5 years (Ylang, Guarana) | Demonstrated to maintain specifications over the duration of its shelf life (2 years or 1.5 years depending on the variant) based on accelerated aging conditions per ASTM F1980-16. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each test set (e.g., number of units tested for viscosity, number of animals for biocompatibility, etc.). It mentions that "all variants of the subject device" were tested for biocompatibility, and "Grosz Play Aloe, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry" were tested for condom compatibility.
The data provenance is presented as standard laboratory testing results, rather than clinical data from human subjects or retrospective/prospective studies. The tests mentioned (e.g., ASTM, ISO, EP standards) are laboratory-based. Therefore, there is no specific country of origin or retrospective/prospective designation for the data in the context of clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of device and testing described. The "ground truth" for these tests is established by recognized international standards (e.g., ISO, ASTM, European Pharmacopoeia) and the results are objectively measured in a laboratory setting, not through expert human interpretation.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among readers. For laboratory tests described here, results are quantitatively measured or observed against predefined criteria, eliminating the need for adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is a personal lubricant and not an AI-assisted diagnostic or clinical decision support device. Therefore, there is no effect size of human readers improving with AI assistance to report.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a personal lubricant; it does not involve any algorithm or AI for its function.
7. Type of Ground Truth Used
The ground truth used for these tests is based on established international standards and objective laboratory measurements. This includes:
- Predefined physical chemical ranges (e.g., for viscosity, pH, osmolality).
- Specific microbiological limits (e.g., cfu/g, absence of specific organisms).
- Biological responses as defined by ISO 10993 series (e.g., non-cytotoxic, non-irritating).
- Compatibility definitions as per ASTM D7661-10.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product (personal lubricant).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) LLC399 Interpace ParkwayParsippany NJ 07054-0224973-404-2715 |
|---|---|
| Contact Person: | Lisa BurnsRegulatory Sr.Manager RBHealth (US) LLC862-325-0012 |
| Date Prepared: | February 25, 2022 |
| Device/Trade Name: | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry,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-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 MoldCount (TYMC)* | < 10 cfu/g | < 10 cfu/g | < 10 cfu/g | < 10 cfu/g | < 10 cfu/g |
| Total Aerobic MicrobialCount (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 EffectivenessTesting | 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,Pseudomonas aeruginosa,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,Aspergillus niger (A.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) | K2134000Subject Device | K211088Predicate Device |
|---|---|---|
| Device Name | Grosz Play Aloe, Grosz PlayYlang, Grosz Play Guarana,Grosz Play Cherry, Grosz Play | Grosz Play Feel |
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| Strawberry | ||
|---|---|---|
| Indications forUse | Grosz Play Aloe, Grosz Play Ylang,Grosz Play Guarana, Grosz Play Cherry,and Grosz Play Strawberry are personallubricants intended for penile, vaginaland/or anal application to moisturize andlubricate, to enhance the ease andcomfort of intimate sexual activity andsupplement the body's naturallubrication. They are compatible withnatural rubber latex and polyisoprenecondoms. They are not compatible withpolyurethane condoms. | Grosz Play Feel is intended for penile,vaginal and/or anal application tomoisturize and lubricate, to enhancethe ease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. Grosz Play Feel iscompatible with natural rubber latexand polyisoprene condoms. Grosz PlayFeel is not compatible withpolyurethane condoms. |
| Rx/OTC | OTC | OTC |
| PhysicalFeatures | Homogenous transparent gel | Homogeneous clear gel |
| Base Type | Water | Water |
| Sterile | No | No |
| PrimaryIngredients | Water, Propylene Glycol, XanthanGum, Carbomer, Benzoic Acid,Sodium Hydroxide, SodiumSaccharin, Flavor. | Water, Propylene Glycol, Xanthan Gum,Carbomer, Benzoic Acid, SodiumHydroxide. |
| BiocompatibilityTested | Yes | Yes |
| AntimicrobialTested | Yes | Yes |
| CondomCompatibility | Compatible with natural rubber latexand polyisoprene condoms. Notcompatible with polyurethane condoms. | Compatible with natural rubber latexand polyisoprene condoms. Notcompatible with polyurethane condoms. |
| Shelf Life | Grosz Play Aloe, Grosz PlayCherry, Grosz Play Strawberry: 2yearsGrosz Play Ylang, Grosz PlayGuarana: 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.
§ 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.