(311 days)
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).
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.
This document is a 510(k) Summary for SUSTAIN Natural Rubber Latex Condoms. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to established standards and specifications as acceptance criteria. The device performance is deemed to meet these criteria by conforming to them.
| Acceptance Criteria / Standard | Reported Device Performance (Conforms to) |
|---|---|
| ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condom) | Yes |
| ISO 4074 Natural Rubber Latex Condoms - Requirements and Test Methods | Yes |
| ISO 10993 Biological Evaluation of Medical Devices | Yes |
| ISO 10993-5 [2009] Tests for In Vitro Cytotoxicity | Yes |
| ISO 10993-10 [2010] Tests for Irritation and Skin Sensitization (Penile Irritation) | Yes |
| ISO 10993-10 [2010] Tests for Irritation and Skin Sensitization (Primary Irritation) | Yes |
| ISO 10993-10 [2010] Tests for Irritation and Skin Sensitization (Vaginal Irritation) | Yes |
| ISO 10993-10 [2010] Skin Sensitization Study (GPMT) of Refined Cotton Seed Oil Extract in Guinea Pigs | Yes |
| ISO 10993-10 [2010] Skin Sensitization Study (GPMT) of Normal Saline Extract in Guinea Pigs | Yes |
| ISO 10993-11 [2009] Tests for Systemic Toxicity | Yes |
| Specific Product Specifications: | |
| Sustain Tailored Fit: | |
| Nominal Length | 186 ± 4 mm (meets ASTM D3492-08) |
| Nominal Width | 49 ± 2 mm (meets ASTM D3492-08) |
| Nominal Thickness | 0.065 ± 0.005 mm (meets ASTM D3492-08) |
| Sustain Ultra Thin: | |
| Nominal Length | 186 ± 4 mm (meets ASTM D3492-08) |
| Nominal Width | 52 ± 2 mm (meets ASTM D3492-08) |
| Nominal Thickness | 0.055 ± 0.005 mm (meets ASTM D3492-08) |
| Sustain Comfort Fit: | |
| Nominal Length | 186 ± 4 mm (meets ASTM D3492-08) |
| Nominal Width | 52 ± 2 mm (meets ASTM D3492-08) |
| Average Thickness | 0.065 ± 0.005 mm (meets ASTM D3492-08) |
Note: The document focuses on demonstrating substantial equivalence to predicate devices and conformance to recognized standards, rather than reporting specific numerical performance metrics from independent studies for each acceptance criterion with associated confidence intervals or statistical power. The "reported device performance" is essentially the statement that the devices "conform to" these standards.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test described under "Nonclinical Testing," nor does it mention the data provenance (e.g., country of origin, retrospective or prospective). It simply lists the standards and the types of tests performed. For biological evaluation, the ISO 10993 series refers to standardized testing protocols, which would inherently include specified sample sizes for in vitro and in vivo tests (like guinea pig sensitization). However, these specific sample sizes are not detailed in this submission.
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 this type of device submission. The "ground truth" for male latex condoms is established by their adherence to international and national standards (ASTM, ISO), which define performance characteristics for efficacy (e.g., prevention of pregnancy, STI transmission) and safety (e.g., biocompatibility, physical properties). These standards are developed by expert committees, but the individual "experts" establishing ground truth for a specific test set are not described in this document in the context of human interpretation of data for diagnostic purposes.
4. Adjudication Method for the Test Set:
Not applicable. This device is a physical medical device (condom) and its performance is evaluated against engineering/material standards and biological safety tests, not through human interpretation of clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret medical images or data. The device in question is a physical barrier contraceptive.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical properties and biocompatibility.
7. Type of Ground Truth Used:
The "ground truth" used for this device's evaluation is based on established international and national consensus standards and specifications (ASTM D3492-08, ISO 4074, ISO 10993 series). These standards define the acceptable physical properties (length, width, thickness), burst strength, leakage, and biocompatibility requirements for male latex condoms to be considered safe and effective for their intended use. This is a form of standards-based ground truth.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI or machine learning model, so there is no "training set."
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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510(k) SUMMARY
| Submitted by: | Hollender Sustainable Brands LLC212 Battery StreetBurlington, VT 05401 | 807.92(a)(1) | |
|---|---|---|---|
| Contact Person: | Jeffrey Hollender, CEOTelephone:Fax:Email: | 802-846-3443802-863-4724jeffrey@jeffreyhollender.com | |
| Date Prepared: | April 21, 2014 | ||
| Proprietary Name: | SUSTAIN Natural Rubber Latex Condoms:Tailored Fit,Ultra Thin, and Comfort Fit807.92(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 ComfortLatex,Rubber Condoms | K980319 |
| London International USHoldings | Durex Colors and Scents,Latex Condoms withLubricant and FragranceAdditives | 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 FitNatural Rubber LatexCondomsare used forcontraception and forprophylactic purposes (tohelp prevent pregnancy andthe transmission of sexuallytransmitted infections). | A Natural Rubber LatexCondom is intended to beworn over the male penisduring acts of vaginalintercourse to aid in theprevention of pregnancyand spread of sexuallytransmitted infections. | Equivalent |
| Straight walled teatended | Yes | Yes | Identical |
| Nominal length | 186 ±4mm | 180±10mm | Both meetASTM D3492-08 lengthspecifications |
| Nominal width | 49±2mm | 52±2mm | Both meetASTM D3492-08 widthspecifications |
| Nominal thickness | 0.065 ± 0.005mm | 0.060 - 0.068mm | Both meetASTM D3492-08 thicknessspecifications |
| Smooth surface | Yes | Yes | Identical |
| Magnesium carbonateand Calcium carbonatedusting powder | Yes | Yes | Identical |
| Lubricated with Siliconebase | Lubricated with Silicone Oil | Lubricated with SiliconeBase Zeus Odor Maskerand flavors | Predicate usesthe identicalsilicone oilbase andincorporates anodor maskerand flavors intothe lubricant |
| Transparent | Yes | Colored | Predicate offersdifferentflavors 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 SustainableBrands LLC | London International LLC | SimilaritiesandDifferences |
|---|---|---|---|
| 510(k) Number | K131866 | K980319 | |
| Intended Use | The Sustain Ultra ThinNatural Rubber LatexCondomsare used forcontraception and forprophylactic purposes (tohelp prevent pregnancy andthe transmission of sexuallytransmitted infections). | A Natural Rubber LatexCondom is intended to beworn over the male penisduring acts of vaginalintercourse to aid in theprevention of pregnancyand spread of sexuallytransmitted infections. | Similar |
| Parallel teat ended | Yes | Bulbous teat ended | Both meetASTM D3492-08specifications |
| Nominal length | 186±4mm | 200±10mm | Both meetASTM D3492-08 lengthspecifications |
| Nominal width | 52±2mm | 56±2mm | Both meetASTM D3492-08 widthspecifications |
| Nominal thickness | 0.055±0.005 mm | 0.055±0.005 mm | Identical |
| Smooth surface | Yes | Yes | Identical |
| Magnesium carbonateand Calcium carbonatedusting powder | Yes | Yes | Identical |
| Lubricated with Siliconebase | Lubricated with Silicone Oil | Lubricated with SiliconeBase Zeus Odor Masker | Predicate usesthe identicalsilicone oilbase andincorporates anodor maskerinto thelubricant |
Predicate Product Comparison Sustain Ultra Thin Natural Rubber Latex Condom Table 2
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| . | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
|---|---|---|---|
| POMONO POM. | State for Jan 20171------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 11------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 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 FitNatural Rubber latexCondom Parameters | Hollender SustainableBrands LLC | London InternationalLLC | Similarities andDifferences |
|---|---|---|---|
| 510(k) Number | K131866 | K980319 | |
| Intended Use | The Sustain Comfort FitNatural Rubber LatexCondomsare used forcontraception and forprophylactic purposes (tohelp prevent pregnancy andthe transmission of sexuallytransmitted infections). | A Natural Rubber LatexCondom is intended to beworn over the male penisduring acts of vaginalintercourse to aid in theprevention of pregnancyand spread of sexuallytransmitted infections. | Identical |
| Bulbous shaped teatended | Yes | Yes | Identical |
| Nominal length | $186\pm4mm$ | Length $200\pm10mm$ | Both meetASTM D3492-08 lengthspecifications |
| Width | The closed end of thecondom has a Bulbous withslightly increased width of$57mm - 59mm$Nominal width of $52\pm2mm$ | The closed end of thecondom has a Bulbouswith slightly increasedwidth of $59mm-61mm$Nominal width of$56\pm2mm$ | Nominal widthmeets ASTMD3492-08specifications.Bulbous widthis not a safetyconcern. |
| Average thickness | $0.065 \pm 0.005mm$ | $0.055 \pm 0.005mm$ | Both meetASTM D3492-08 thicknessspecifications |
| Smooth surface | SmoothSurface | Smooth Surface | Identical |
| Magnesium carbonateand Calcium carbonatedusting powder | Yes | Yes | Identical |
Prodicate Product Comparison Sustain Comfort Fit Noturel Rubber Lotox Condom Tahle 3
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| Lubricated with Siliconebase | Lubricated with Silicone Oil | Lubricated with SiliconeBase Zeus Odor Masker | Predicate usesthe identicalsilicone oil butincorporates anodor maskerinto thelubricant |
|---|---|---|---|
| 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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§ 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.