(448 days)
Not Found
No
The device description and performance studies focus on the chemical formulation, physical properties, and biocompatibility of personal lubricants. There is no mention of AI or ML technology in the document.
No.
The device is intended for moisturizing, lubricating, and enhancing comfort during sexual activity, which are not considered therapeutic purposes in the context of treating or preventing a disease or condition.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate to enhance comfort during intimate sexual activity. Its function is to supplement natural lubrication, not to diagnose any medical conditions.
No
The device description clearly states that the devices are physical products (personal lubricants) packaged in bottles, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for moisturizing and lubricating during intimate sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The device is described as a personal lubricant with specific formulations for lubrication. There is no mention of it being used to test samples from the human body (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There are no mentions of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not a diagnostic device.
- Predicate Devices: The predicate devices are also personal lubricants (Swiss Navy Premium Silicone Lubricant and Swiss Navy Premium Water-Based Lubricant), further indicating the device's classification.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
NUC
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 bottles and topped with a polypropylene cap and packaged together in a carton. Grosz KY Yours & Mine are for OTC use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, vaginal and/or anal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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". The results of this testing demonstrated that the subject lubricants are biocompatible.
Shelf-life duration for Grosz Warming Liquid is 15 months, and for Grosz Play Tingling, Grosz KY Yours, and Grosz KY Mine is 2 years. These durations are based on 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 listed in Tables 1 and 2 were met.
Condom compatibility 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 found compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Grosz Play Tingling was compatible with natural rubber latex and polyisoprene condoms but not with polyurethane condoms. Grosz KY Yours & Mine, when used together, was compatible with natural rubber latex and polyisoprene condoms but not with polyurethane condoms.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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,
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
| Regulation Number: 21 CFR 884.5300 | |
| Product Code: NUC (lubricant, personal) | |
| Device Class: Class II | |
| Predicate Device: | Swiss Navy Premium Silicone Lubricant and Swiss Navy Premium |
| Water-Based Lubricant | |
| 510(k) Number: K150153 | |
| Manufacturer: Package Solutions LLC | |
| Product Code: NUC | |
| 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
4
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 | 70-110 cPs |
| Antimicrobial effectiveness per USP | 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 | |
| pH per USP | 3.5 - 4.5 |
| Osmolality per USP |
| 883-1,200 mOsm/kg |
| Antimicrobial
effectiveness per method
equivalent to USP | Bacteria: NLT 3.0 log reduction from the initial count at 7 days, and
no increase from 7 days' count at 28 days; Yeasts/Molds: 2.0 log
reduction from the initial count at 14 days, and no increase from
the 14 days' count at 28 days. |
| Total aerobic microbial
count (TAMC) per
method equivalent to
USP | | | 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.
6
| Feature | Grosz
Warming
Liquid
K213892 | Grosz Play
Tingling
K213892 | Grosz KY Yours &
Mine
K213892 | Swiss Navy Premium
[Silicone Lubricant
and Water-Based
Lubricant]
K150153 | Comments |
|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The Swiss Navy
Premium Lubricants
are personal
lubricants for penile
and / or vaginal
application, intended
to moisturize and
lubricate, to enhance
the ease and comfort
of intimate sexual
activity and
supplement the
body's natural
lubrication. These
products are
compatible with
natural rubber latex
and polyisoprene
condoms. These
products are not
compatible with
polyurethane
condoms. | The indications for
use statements for
the subject and
predicate devices are
not identical, as the
subject devices are
also indicated for anal
use and have
differences in
condom
compatibility. These
differences do not
represent a new
intended use as both
the subject and
predicate devices are
intended to provide
lubrication to an
orifice with or
without use of
compatible condoms. |
| Base Type | Silicone | Water | Grosz KY Yours:
Silicone
Grosz KY Mine:
Water | Silicone Lubricant:
Silicone
Water-Based Lubricant:
Water | Same: The subject
devices and their
respective predicate
device have the same
base type. |
| Primary
ingredients | Dimethicone,
Sensate | Water,
Propylene
Glycol,
Carbomer,
Xanthan Gum,
Sensate,
Benzoic Acid,
Sodium
Saccharin,
Sodium
Hydroxide | Grosz KY Yours:
Dimethicone, Sensate
Grosz KY Mine:
Water,
Propylene
Glycol,
Carbomer,
Xanthan Gum,
Sensate, Benzoic
Acid, Sodium
Saccharin,
Sodium
Hydroxide | Not available | Differences in
formulations is not
known between Grosz
Warming Liquid/Grosz
KY Yours and the Swiss
Navy Premium Silicone
Lubricant or between
Grosz Play Tingling/Gros
KY Yours and the Swiss
Navy Premium Water
Based Lubricant.
Differences in
formulations do not
raise different
questions of safety |
| | | | | | |
| | | | | | and effectiveness
(S&E). |
| Over the counter
use | Yes | Yes | Yes | Yes | Same: The subject
devices and their
respective predicate
device are for OTC use. |
| Sterile | No | No | No | No | Same: The subject
devices and their
respective predicate
device are non-sterile. |
| Condom
Compatibility | Compatible with
natural rubber
latex and
polyisoprene
condoms and
polyurethane
condoms. | Compatible with
natural rubber
latex and
polyisoprene
condoms. Not
compatible with
polyurethane
condoms. | Compatible with
natural rubber latex
and polyisoprene
condoms. Not
compatible with
polyurethane
condoms. | These products are
compatible with natural
rubber latex and
polyisoprene condoms.
These products are not
compatible with
polyurethane
condoms. | Different: Condom
compatibility differs
between the subject
devices and their
respective predicate
device. Differences in
condom compatibility
does not raise different
questions of S&E. |
| Biocompatibility
Tested | Yes | Yes | Yes | Yes | Same: The subject
devices and their
respective predicate
device were tested and
shown to be
biocompatible. |
| Antimicrobial
Tested | Yes | Yes | Yes | Unknown | Differences in
antimicrobial testing is
not known between
Grosz Warming
Liquid/Grosz KY Yours
and the Swiss Navy
Premium Silicone
Lubricant or between
Grosz Play Tingling/Grosz
KY Yours and the Swiss
Navy Premium Water
Based Lubricant.
Differences in
antimicrobial
testing do not raise
different questions
of safety and
effectiveness (S&E). |
| Microbial Tested
(Total aerobic
microbial count,
total yeast and
mold count,
absence of
pathogens) | Yes | Yes | Yes | Yes | Same: The subject
devices and their
respective predicate
device completed this
testing. |
| pH Tested | No | Yes | Grosz KY Yours: No | Silicone Lubricant: No | Same: The subject
devices and their
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. |
7
8
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.
9
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.