Bloomi Smooth Water Based Lubricant

K221328 · The Bloomi Inc.. · NUC · Aug 4, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K221328
• Device Name: Bloomi Smooth Water Based Lubricant
• Applicant: The Bloomi Inc..
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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 polvurethane condoms.

Device Story

Bloomi Smooth Water Based Personal Lubricant is a non-sterile, water-based lubricant intended for OTC use to enhance comfort during intimate sexual activity. It is applied topically to the penis and/or vagina. The device supplements natural lubrication and is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms. It is supplied in a 3 oz MDPE tube. The lubricant is formulated with water, hydroxyethylcellulose, guar gum, citric acid, sodium hyaluronate, and botanical extracts (sunflower, green tea). The user applies the lubricant manually as needed. The device provides physical lubrication to reduce friction, thereby potentially increasing comfort and reducing the risk of condom breakage or irritation during sexual activity.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) per ISO 10993 standards confirmed non-toxic, non-irritating, and non-sensitizing profile. Shelf-life validated via accelerated aging (ASTM F1980-16). Condom compatibility tested per ASTM D7661-18.

Technological Characteristics

Water-based lubricant; ingredients include hydroxyethylcellulose, guar gum, sodium hyaluronate, and botanical extracts. Viscosity: 1,800-4,500 cps; Osmolality: 110-140 mOsm/kg; pH: 4.0-5.0. Packaging: MDPE 3 oz tube. Shelf-life: 8.5 months (accelerated aging per ASTM F1980-16). Non-sterile. Microbial limits per USP <61>/<62>.

Indications for Use

Indicated for penile and/or vaginal application to lubricate and moisturize, enhance ease and comfort of intimate sexual activity, and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; not compatible 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

• The Sex Gel Personal Lubricant (K181078)

Submission Summary (Full Text)

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August 4, 2022

The Bloomi, Inc. % Louie Goryoka Sr. QA/RA Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301

Re: K221328

> Trade/Device Name: Bloomi Smooth Water Based Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 3, 2022 Received: May 6, 2022

Dear Louie Goryoka:

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) K221328

Device Name Bloomi Smooth Water Based Personal Lubricant

Indications for Use (Describe)

The Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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 polvurethane condoms.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <span style="font-family: sans-serif;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="orphans: 2;"> <span style="text-align:left;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="-webkit-text-size-adjust: auto;"> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> | |
| <span style="font-family: sans-serif;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="orphans: 2;"> <span style="text-align:left;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="-webkit-text-size-adjust: auto;"> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> | |

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### 510(k) Summary - K221328 Bloomi Smooth Water Based Personal Lubricant

#### l. General Information on Submitter

| Applicant: | The Bloomi, Inc. |
|-----------------|------------------------------------------------------------------|
| Address: | 71 Royal ridge court, California,<br>94507 USA |
| Telephone: | [phone] |
| Contact Person: | Louie Goryoka |
| Contact Title: | Sr. Regulatory/Quality Consultant<br>Med-Device Consulting, Inc. |
| Email: | [e-mail] |
| Date Prepared: | July 27, 2022 |

#### II. General Information on Device

| Proprietary Name: | Bloomi Smooth Water Based Personal Lubricant |
|--------------------|----------------------------------------------|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Class: | II |
| Product Code: | NUC (Lubricant, Personal) |

#### lll. Predicate Device

| Predicate Device | 510(k) Number |
|--------------------------------|---------------|
| The Sex Gel Personal Lubricant | K181078 |

This predicate device has never been the subject of a device recall.

#### IV. Description of Device

The Bloomi Smooth Water Based Personal Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal 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.

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Its formulation consists of Water, Hydroxyethylcellulose, Microcare SB (water, sodium benzoate, potassium sorbate), Activsoft S (Cyamopsis Tetragonoloba (Guar) Gum), Citric Acid, Sodium Hyaluronate, Organic Sunflower Extract, Organic Green Tea Extract (Organic Camellia Sinensis Leaf (Green Tea) Extract).

The Bloomi Smooth Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box for OTC use.

The specifications for Bloomi Smooth Water Based Personal Lubricant are described in Table 1.

| Parameter | Specification (Test Method) |
|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Absence of particulate matter | Clear viscous liquid |
| Color | Off-white |
| Odor | None |
| Viscosity | 1,800 - 4,500 cps |
| Osmolality | 110 - 140 mOsm/kg |
| pH | 4.0 - 5.0 |
| Total yeast/mold count (TYMC) | <10 cfu/mL (USP <61>) |
| Total aerobic microbial count<br>(TAMC) | <100 cfu/mL (USP <61>) |
| Presence of pathogenic organisms<br>( <i>Staphylococcus aureus</i> ,<br><i>Pseudomonas aeruginosa</i> , and<br><i>Candida albicans</i> ) | Absent (USP<62>) |
| Antimicrobial effectiveness | Meets USP<51> acceptance criteria for<br>Category 2 products. |

Table 1. Device Specifications

#### V. Indications for Use

Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended lubricate and moisturize, 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.

#### VI. Substantial Equivalence Discussion

The following table compares the intended use and kev technological characteristics of the subject and predicate device:

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| Characteristic /<br>Feature | Bloomi Smooth Water<br>Based Personal<br>Lubricant (subject<br>device) | The Sex Gel Personal<br>Lubricant (predicate<br>device) - K181078 | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Bloomi Smooth Water Based<br>Personal Lubricant is a water-<br>based personal lubricant for<br>penile and/or vaginal<br>application, intended to<br>lubricate and moisturize,<br>enhance the ease and comfort<br>of intimate sexual activity and<br>supplement the body's natural lubrication. This product is<br>compatible with natural rubber<br>latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | Personal lubricant, for penile<br>and/or vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. This<br>product is compatible with<br>natural rubber latex and<br>polyisoprene and polyurethane<br>condoms. | Similar: The subject and<br>predicate devices have<br>similar indications for use,<br>with the exception of<br>condom compatibility<br>statement, and they have<br>the same intended use. |
| Water-Based<br>Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not a<br>contraceptive or<br>Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary<br>Ingredients | Water, Microcare SB,<br>Microcare SB,<br>Hydroxyethylcellulose,<br>Cyamopsis Tetragonoloba<br>(Guar) Gum, Citric Acid,<br>Sodium Hyaluronate, Organic<br>Helianthus (Sunflower) Seed<br>Extract, Organic Camellia<br>Sinensis Leaf (Green Tea)<br>Extract. | Water, aloe barbadensis<br>leaf juice, sorbitol,<br>hydroxyethylcellulose,<br>allantoin, lactic acid /<br>tocopherols<br>(vitamin E), sodium<br>hyaluronate,<br>sodium benzoate &<br>potassium sorbate | Different |
| Microbial Limits | Total mold/yeast count <10<br>cfu/mL<br>Total aerobic microbial count<br><100 cfu/mL<br>Absence of pathogens<br>(Candida albicans,<br>Pseudomonas aeruginosa,<br>Staphylococcus aureus) | Total mold/yeast count <10<br>cfu/mL<br>Total aerobic microbial count<br><100 cfu/mL<br>Absence of pathogens<br>(Candida albicans,<br>Pseudomonas aeruginosa,<br>Staphylococcus aureus) | Different |
| Viscosity | 1,800-4,500 cps | 3,000-5,000 cps | Different |
| Osmolality | 110-140 mOsm/kg | 435-535 mOsm/kg | Different |
| pH | 4.0-5.0 | 4.0-5.0 | Same |

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The subject and predicate devices have similar indications for use and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different types of safety and effectiveness questions.

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

## Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA quidance 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/(R)2014)
- Guinea Piq Maximization Sensitization (ISO 10993-10:2010/(R)2014) .
- Vaqinal Irritation (ISO 10993-10:2010/(R)2014)
- Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizinq, and not systemically toxic.

## Shelf Life

The subject device is a non-sterile personal lubricant packaged in a 3 oz. tube with a 8.5-month shelf-life in accordance with the results of an accelerated aging study. conducted for 3 months at 40°C per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.

## Condom Compatibility

Bloomi Smooth Water Based Personal Lubricant was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Bloomi Smooth Water Based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. Bloomi Smooth Water Based Personal Lubricant is not compatible with polyurethane condoms.

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#### VIII. Conclusion

The results of the testing described above demonstrate that Bloomi Smooth Water Based Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.