(281 days)
Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex Condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted This condom has the specification as enclosed in membrane. Annexure 2
This is a 510(k) summary for a condom, which is a physical device, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable. However, I will extract and present the available information regarding acceptance criteria and device performance.
Device Name: Green Love Male Latex Condom
510(k) Number: K051842
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (from ASTM D3492-03) | Reported Device Performance (Likely meets, explicitly stated as conforming to ASTM D3492-03) |
|---|---|---|
| Material | Natural Rubber Latex | Natural Rubber Latex |
| Design | Sheath, completely covers penis, closely fitted | Sheath, completely covers penis, closely fitted |
| Size (Length, Width, Thickness) | As per ASTM D3492-03 | Not explicitly stated in the provided text, but implied to meet the standard. |
| Burst Volume/Pressure | As per ASTM D3492-03 | Not explicitly stated in the provided text, but implied to meet the standard. |
| Lubrication | Silicone lubricated | Silicone lubricated |
| Reservoir Tip | Present | Present |
| Intended Use | Contraception, Prophylaxis (prevention of STDs) | Contraception, Prophylaxis (prevention of STDs, including HIV) |
| Water Leakage | As per ASTM D3492-03 | Not explicitly stated in the provided text, but implied to meet the standard. |
Study Proving Device Meets Acceptance Criteria:
The submission states, "This condom design is in conformance with ASTM Latex Condom Standard D 3492-03 and that the condom is made of natural rubber latex." This indicates that the device was tested against the requirements of ASTM D3492-03 and found to meet all specified acceptance criteria within that standard. While specific numerical outcomes are not provided in this summary, the declaration of conformance is the primary evidence provided for meeting acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided 510(k) summary. Testing typically involves a statistical sampling plan as defined by the ASTM standard, but the exact number of condoms tested is not disclosed here.
- Data Provenance: The device manufacturer is CUPID CONDOM LIMITED, located in Maharashtra, India. The testing would have been conducted by or for the manufacturer. The data is retrospective to the submission date of June 30, 2005.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. For a physical device like a condom, "ground truth" is established by direct physical measurement and performance testing according to an engineering standard (ASTM D3492-03). It does not involve expert interpretation or diagnosis of images or clinical conditions in the same way an AI medical device would. The "experts" in this context would be trained technicians and engineers performing the tests.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, adjudication by multiple experts for "ground truth" establishment is not relevant for this type of device testing. Performance is measured objectively against the standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This type of study is relevant for diagnostic devices where human readers interpret data, often with AI assistance. It is not applicable to the performance testing of a physical contraceptive device like a condom.
6. Standalone Performance Study:
- Yes, a standalone performance assessment was done. The entire 510(k) submission, particularly the statement of conformance to ASTM D3492-03, represents a standalone performance assessment of the device against established engineering and safety standards. This assessment evaluates the condom's physical properties (e.g., burst strength, freedom from holes, dimensions) independent of human-in-the-loop interaction in a diagnostic or interpretive sense.
7. The Type of Ground Truth Used:
- Engineering Standard and Physical Measurement. The "ground truth" for this device's performance is defined by the objective, measurable parameters and test methods outlined in the ASTM Latex Condom Standard D 3492-03. This includes measurements of dimensions, burst volume/pressure, and water leakage tests.
8. Sample Size for the Training Set:
- Not Applicable. As a physical device, there is no "training set" in the context of machine learning. The manufacturing process is controlled and validated, but there isn't a separate data set used to "train" the device itself.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As explained in point 8, there is no "training set" for this type of device.
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510 = K SUMMARY
APR 1 4 2006
| Submitted by | CUPID CONDOM LIMITEDA-68, M.I.D.C. (Malegaon)Sinnar, Nasik - 422133Maharashtra, INDIA |
|---|---|
| Contact Person | Mr. K.K. GOYAL / Mr. O.P. GARG |
| Date Prepared | 30th June 2005 |
| Proprietary Name | GREEN LOVE |
| Common Name | Natural Latex, silicone lubricated, reservoirtipped, Condom |
| Classification Name | Condom (21 CFR 884.5300) |
| Predicate Device510 - K No : | KAMA SUTRA Latex Lubricated CondomK 931077 / B |
Description of Device: This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted This condom has the specification as enclosed in membrane. Annexure 2
Intended use of the Device: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purpose (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Technological Characteristics: This condom has the same technological characteristics as the predicate condom identified above. This condom design is in conformance with ASTM Latex Condom Standard D 3492-03 and that the condom is made of natural rubber latex
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 4 2006
Mr. K.K. Goyal C.E.O. Cupid Condom Ltd. A-68 M.I.D.C. Sinnar MALEGAON, Nashik, 422 113 INDIA
Re: K051842
Trade/Device Name: Green Love Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 10, 2006 Received: March 14, 2006
Dear Mr. Goyal:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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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Promoting Public Health
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051842
Device Name: Green Love Male Latex Condom
Indications For Use:
"Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex Condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases."
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Ingram
(Division S:
Division and Rac
510(k) Numuz
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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.