SUSTAIN

K131866 · Hollender Sustainable Brands, LLC · HIS · May 1, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K131866
• Device Name: SUSTAIN
• Applicant: Hollender Sustainable Brands, LLC
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: May 1, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sustain Tailored Fit, Ultra Thin and Comfort Fit condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Story

SUSTAIN Natural Rubber Latex Condoms are male condoms designed for contraception and prophylaxis against sexually transmitted infections. The device consists of a natural rubber latex sheath, available in three variants: Tailored Fit (straight-walled), Ultra Thin (straight-walled), and Comfort Fit (bulbous-shaped). All variants are transparent, teat-ended, and lubricated with silicone oil. The device is intended for over-the-counter use by individuals. It functions as a physical barrier to prevent the exchange of bodily fluids during intercourse. Safety and effectiveness are established through adherence to established material and performance standards, ensuring the device provides a reliable barrier for the user.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including compliance with ASTM D3492-08 (Standard Specification for Rubber Contraceptives) and ISO 4074 (Natural Rubber Latex Condoms Requirements and Test Methods), as well as biocompatibility testing per ISO 10993 (cytotoxicity, irritation, sensitization, and systemic toxicity).

Technological Characteristics

Materials: Natural rubber latex. Lubricant: Silicone oil. Additives: Magnesium carbonate and calcium carbonate dusting powder. Design: Cylindrical, straight-walled or bulbous-shaped, teat-ended. Dimensions: Length 186±4mm; Width 49-52±2mm; Thickness 0.055-0.065±0.005mm. Standards: ASTM D3492-08, ISO 4074, ISO 10993. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for use by individuals for contraception and the prevention of pregnancy and sexually transmitted infections.

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

• Ultra Comfort Latex, Rubber Condoms (K980319)
• Durex Colors and Scents, Latex Condoms with Lubricant and Fragrance Additives (K980174)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

| Submitted by: | Hollender Sustainable Brands LLC<br>212 Battery Street<br>Burlington, VT 05401 | | 807.92(a)(1) |
|----------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------|
| Contact Person: | Jeffrey Hollender, CEO<br>Telephone:<br>Fax:<br>Email: | 802-846-3443<br>802-863-4724<br>[e-mail] | |
| Date Prepared: | April 21, 2014 | | |
| Proprietary Name: | SUSTAIN Natural Rubber Latex Condoms:Tailored Fit,<br>Ultra Thin, and Comfort Fit<br>807.92(a)(2) | | |
| Common Name: | Male Latex Condoms | | |
| Classification Name: | Condom (21 CFR §884.5300) Code HIS | | |

| Predicate Devices: | | 807.92(a)(3) |
|-------------------------------------|----------------------------------------------------------------------------------------|---------------|
| Manufacturer | Brand Name | 510(k) Number |
| London International LLC | Ultra Comfort<br>Latex,Rubber Condoms | K980319 |
| London International US<br>Holdings | Durex Colors and Scents,<br>Latex Condoms with<br>Lubricant and Fragrance<br>Additives | K980174 |

#### Description of the Device:

807.92(a)(4)

The SUSTAIN Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These condoms conform to ISO 4074 Natural Rubber Latex Condoms - Requirements and Test Methods, ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condom), and ISO 10993 Biological Evaluation of Medical Devices.

#### Product Smooth Surface - Sustain Tailored Fit

The Sustain Tailored Fit Natural Rubber Latex Condoms are parallel straight walled teat ended with smooth surface, transparent, having a nominal length of 186 ±4 mm, a nominal width of 49±2mm and a nominal thickness of 0.065 ± 0.005mm.

#### Product Smooth Surface - Sustain Ultra Thin

The Sustain Ultra Thin Natural Rubber Latex Condoms are parallel straight walled teat ended with smooth surface, transparent, having a nominal length of 186 ±4 mm, a nominal width of 52±2 mm and a nominal thickness of 0.055 ± 0.005mm.

#### Product Smooth Surface - Bulbous - Sustain Comfort Fit

The condoms are bulbous shaped teat ended with smooth surface, transparent, having a nominal length of 186 ±4mm, a nominal width of 52±2mm and a nominal thickness of 0.065 ± 0.005mm.

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#### Intended Use of the Device:

## 807.92(a)(5)

The Sustain Tailored Fit, Ultra Thin and Comfort Fit condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

#### Predicate Product Comparison

## 807.92(a)(6)

| Table I | Predicate Product Comparisons - Sustain Tailored Fit Natural Rubber Latex Condom | | |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Parameters | Hollender Sustainable | London International | Similarities and |
| | Brands LLC | LLC | Differences |
| 510(k) Number | K 131866 | K980174 | |
| Intended Use | The Sustain Tailored Fit<br>Natural Rubber Latex<br>Condomsare used for<br>contraception and for<br>prophylactic purposes (to<br>help prevent pregnancy and<br>the transmission of sexually<br>transmitted infections). | A Natural Rubber Latex<br>Condom is intended to be<br>worn over the male penis<br>during acts of vaginal<br>intercourse to aid in the<br>prevention of pregnancy<br>and spread of sexually<br>transmitted infections. | Equivalent |
| Straight walled teat<br>ended | Yes | Yes | Identical |
| Nominal length | 186 ±4mm | 180±10mm | Both meet<br>ASTM D3492-<br>08 length<br>specifications |
| Nominal width | 49±2mm | 52±2mm | Both meet<br>ASTM D3492-<br>08 width<br>specifications |
| Nominal thickness | 0.065 ± 0.005mm | 0.060 - 0.068mm | Both meet<br>ASTM D3492-<br>08 thickness<br>specifications |
| Smooth surface | Yes | Yes | Identical |
| Magnesium carbonate<br>and Calcium carbonate<br>dusting powder | Yes | Yes | Identical |
| Lubricated with Silicone<br>base | Lubricated with Silicone Oil | Lubricated with Silicone<br>Base Zeus Odor Masker<br>and flavors | Predicate uses<br>the identical<br>silicone oil<br>base and<br>incorporates an<br>odor masker<br>and flavors into<br>the lubricant |
| Transparent | Yes | Colored | Predicate offers<br>different<br>flavors and |

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| AND CHANAL CHARACT LAND | A LED OR AND LEASE I FAR IN AND LINER FRANCE CHANAL CONSULTER OF LEASE | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |

Technological Characteristics Sustain Tailored Fit Natural Rubber Latex Condom 807.92(a)(6)

The Sustain Tailored Fit Natural Rubber Latex Condom and the predicate device (K980174) are made from natural rubber latex, with biocompatible materials and designs in conformance with the requirements of ASTM D 3492-08 Standard Specification for Rubber Contraceptives (Male Condom). Both are cylindrical, straight-walled, teat ended, and use silicone oil as a lubricant. The Sustain Tailored Fit Natural Rubber Latex Condom is transparent and has no flavors or colors, whereas the predicate device (K980174) has flavors and colors. The absence of flavors and colors has no material impact on safety and effectiveness.

| Parameters | Hollender Sustainable<br>Brands LLC | London International LLC | Similarities<br>and<br>Differences |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K131866 | K980319 | |
| Intended Use | The Sustain Ultra Thin<br>Natural Rubber Latex<br>Condomsare used for<br>contraception and for<br>prophylactic purposes (to<br>help prevent pregnancy and<br>the transmission of sexually<br>transmitted infections). | A Natural Rubber Latex<br>Condom is intended to be<br>worn over the male penis<br>during acts of vaginal<br>intercourse to aid in the<br>prevention of pregnancy<br>and spread of sexually<br>transmitted infections. | Similar |
| Parallel teat ended | Yes | Bulbous teat ended | Both meet<br>ASTM D3492-<br>08<br>specifications |
| Nominal length | 186±4mm | 200±10mm | Both meet<br>ASTM D3492-<br>08 length<br>specifications |
| Nominal width | 52±2mm | 56±2mm | Both meet<br>ASTM D3492-<br>08 width<br>specifications |
| Nominal thickness | 0.055±0.005 mm | 0.055±0.005 mm | Identical |
| Smooth surface | Yes | Yes | Identical |
| Magnesium carbonate<br>and Calcium carbonate<br>dusting powder | Yes | Yes | Identical |
| Lubricated with Silicone<br>base | Lubricated with Silicone Oil | Lubricated with Silicone<br>Base Zeus Odor Masker | Predicate uses<br>the identical<br>silicone oil<br>base and<br>incorporates an<br>odor masker<br>into the<br>lubricant |

Predicate Product Comparison Sustain Ultra Thin Natural Rubber Latex Condom Table 2

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| | | . | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| POMONO POM<br>. | <br>State for Jan 2017<br>1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1<br>1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 |
| | | . | |

Technological Characteristics - Sustain Ultra Thin Natural Rubber Latex Condom 807.92(a)(6)

The Sustain Ultra Thin Natural Rubber Latex Condom and the predicate device (K980319) are made from natural rubber latex, with biocompatible materials and designs in conformance with the requirements of ASTM D 3492-08 Standard Specification for Rubber Contraceptives (Male Condom). Both are smooth surface, use identical dusting powder, use silicone oil as a lubricant, and are transparent. The predicate offers a bulbous teat ended feature and the Sustain Ultra Thin Natural Rubber Latex Condom offers a teat ended feature. The difference between the two features has no material impact on the safety and effectiveness as both condoms meet ASTM D 3492-08 Standard Specification for Rubber Contraceptives (Male Condom) recommendations. The differences in the nominal length and nominal width has no material impact on safety and effectiveness as both condoms fall within ASTM D 3492-08 Standard Specification for Rubber Contraceptives (Male Condom) length and width specifications.

| Sustain Comfort Fit<br>Natural Rubber latex<br>Condom Parameters | Hollender Sustainable<br>Brands LLC | London International<br>LLC | Similarities and<br>Differences |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K131866 | K980319 | |
| Intended Use | The Sustain Comfort Fit<br>Natural Rubber Latex<br>Condomsare used for<br>contraception and for<br>prophylactic purposes (to<br>help prevent pregnancy and<br>the transmission of sexually<br>transmitted infections). | A Natural Rubber Latex<br>Condom is intended to be<br>worn over the male penis<br>during acts of vaginal<br>intercourse to aid in the<br>prevention of pregnancy<br>and spread of sexually<br>transmitted infections. | Identical |
| Bulbous shaped teat<br>ended | Yes | Yes | Identical |
| Nominal length | $186\pm4mm$ | Length $200\pm10mm$ | Both meet<br>ASTM D3492-<br>08 length<br>specifications |
| Width | The closed end of the<br>condom has a Bulbous with<br>slightly increased width of<br>$57mm - 59mm$<br>Nominal width of $52\pm2mm$ | The closed end of the<br>condom has a Bulbous<br>with slightly increased<br>width of $59mm-61mm$<br>Nominal width of<br>$56\pm2mm$ | Nominal width<br>meets ASTM<br>D3492-08<br>specifications.<br>Bulbous width<br>is not a safety<br>concern. |
| Average thickness | $0.065 \pm 0.005mm$ | $0.055 \pm 0.005mm$ | Both meet<br>ASTM D3492-<br>08 thickness<br>specifications |
| Smooth surface | SmoothSurface | Smooth Surface | Identical |
| Magnesium carbonate<br>and Calcium carbonate<br>dusting powder | Yes | Yes | Identical |

Prodicate Product Comparison Sustain Comfort Fit Noturel Rubber Lotox Condom Tahle 3

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| Lubricated with Silicone<br>base | Lubricated with Silicone Oil | Lubricated with Silicone<br>Base Zeus Odor Masker | Predicate uses<br>the identical<br>silicone oil but<br>incorporates an<br>odor masker<br>into the<br>lubricant |
|----------------------------------|------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Transparent | Yes | Yes | Identical |

#### Technological Characteristics Sustain Comfort Fit Natural Rubber latex Condom

The Sustain Comfort Fit Natural Rubber Latex Condom and the predicate device (K980319) are made from natural rubber latex, with biocompatible materials and designs in conformance with the requirements of ASTM D 3492-08 Standard Specification for Rubber Contraceptives (Male Condom). Both are cylindrical, bulbous shaped teat ended, smooth surface; use identical dusting powder, use silicone oil as a lubricant, and are transparent. The differences in the nominal length, nominal width and nominal thickness has no material impact on safety and effectiveness as both condoms fall within ASTM D 3492-08 Standard Specification for Rubber Contraceptives (Male Condom) length, width and thickness specifications.

### Nonclinical Testing

#### 807.92(b)

The following tests were performed on the Natural Rubber Latex Condoms:

- ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) ●
- ISO 4074:2002 Natural Rubber Latex Condoms Requirements and Test Methods ●
- ISO 10993-5 [2009] Biological Evaluation of Medical Devices Part 5: Tests for In Vitro ● Cytotoxicity
- ISO 10993-10 [2010] Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization (Penile Irritation)
- . ISO 10993-10 [2010] Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization (Primary Irritation)
- . ISO 10993-10 [2010] Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization (Vaginal Irritation)
- . ISO 10993-10 [2010] Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization (Skin Sensitization Study (GPMT) of Refined Cotton Seed Oil Extract in Guinea Pigs)
- . ISO 10993-10 [2010] Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization(Skin Sensitization Study (GPMT) of Normal Saline Extract in Guinea Pigs)
- ISO 10993-11 [2009] Biological Evaluation of Medical Devices - Part 11: Tests for ● Systemic Toxicity

### Clinical Testing

No clinical testing was performed.

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#### Conclusion

## 807.92(b)(3)

The Sustain Tailored Fit, Ultra Thin and Comfort Fit Natural Rubber Latex Condoms are substantially equivalent to the predicate device in indications for use, materials and design. Safety and performance testing to ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms)and ISO 10993 Biological Evaluation of Medical Devices has concluded that the Sustain Tailored Fit, Ultra Thin and Comfort Fit Natural Rubber Latex Condoms are substantially equivalent to the predicate devices (K980174 and K980319) in terms of safety and effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 15, 2014

Hollender Sustainable Brands, LLC % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K131866

> Trade/Device Name: SUSTAIN Tailored Fit, Ultra Thin and Comfort Fit Natural Rubber Latex Condoms Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated (Date on orig SE Itr): April 4, 2014 Received (Date on orig SE Itr): April 4, 2014

Dear E.J. Smith.

This letter corrects our substantially equivalent letter of May 1, 2014.

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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.

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Page 2 - E.J. Smith

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K131866

#### Device Name

SUSTAIN Tailored Fit, Ultra Thin and Comfort Fit Natural Rubber Latex Condoms

Indications for Use (Describe)

The Sustain Tailored Fit, Ultra Thin and Comfort Fit condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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