(281 days)
K 931077
Not Found
No
The document describes a standard latex condom and contains no mention of AI, ML, or related concepts.
No
The device is described as a contraceptive and an aid in the prevention of sexually transmitted diseases, which are prophylactic uses, not therapeutic (treating an existing condition).
No
Condoms are designed for contraception and prevention of disease transmission, not for diagnosing medical conditions.
No
The device description explicitly states it is a "natural rubber latex sheath," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prophylaxis against STDs during sexual intercourse. This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description details a physical sheath made of latex that covers the penis. This aligns with a physical barrier device, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a disease or condition
Therefore, this device is classified as a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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."
Product codes
HIS
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 931077 / B
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510 = K SUMMARY
APR 1 4 2006
| Submitted by | CUPID CONDOM LIMITED
A-68, M.I.D.C. (Malegaon)
Sinnar, Nasik - 422133
Maharashtra, 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, reservoir
tipped, Condom |
| Classification Name | Condom (21 CFR 884.5300) |
| Predicate Device
510 - K No : | KAMA SUTRA Latex Lubricated Condom
K 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
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a circular border with additional text, but the text is too small to read.
Promoting Public Health
2
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
3
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
Page 1 of 1