(78 days)
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Not Found
No
The 510(k) summary describes a standard male condom and contains no mention of AI, ML, or any related technologies.
No
The device is intended for prophylactic purposes (preventing pregnancy and STDs), not for treating an existing disease or condition.
No
Explanation: The device is a condom, used for prophylactic purposes to prevent pregnancy and STDs. This description does not indicate any diagnostic function.
No
The device description clearly states it is a "Male Natural Rubber Latex Condom," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health. Examples include blood tests, urine tests, and tissue biopsies.
- This device is a condom. Its intended use is for physical barrier contraception and prevention of disease transmission during sexual activity. It does not involve the examination of bodily specimens for diagnostic purposes.
The provided information clearly describes a physical barrier device for prophylactic use, not a diagnostic test.
N/A
Intended Use / Indications for Use
The [No particular brand name] condom is used for prophylactic purposes (to help contraception and for proporty and the transmission of sexually transmitted diseases).
Product codes
HIS
Device Description
Male Natural Rubber Latex Condom
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing people or services provided by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2006
Mr. Goh Miah Kiat General Manager Innolatex Sdn. Bhd. Lot 594, Persiaran Raja Lumu 42000 Port Klang, Selangor Darul Ehsan MALAYSIA
Re: K053367
Trade/Device Name: Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: November 28, 2005 Received: December 5, 2005
Dear Mr. Kiat:
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 the cholors's to regardy man date of the Medical Device Amendments, or to devices that have been reasy 20, 1710, 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 do not require approvince controls provisions of the Act. The general controls provisions of the Act ac not, subject to the general 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 I tpp. o an 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 Eederal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that I lease of advisou determination that your device complies with other requirements of the Act or any F Drivals made 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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) Fins letter will anon-you ve arger.
The finding the FDA finding of substantial equivalence of your device to a legally prematice notification: "The 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 If you desire specific acries for your as 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 Also, prease note togalation ecencral information on your responsibilities under the Act from the 807.77). Tod may of Small Manufacturer 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 vours.
T. Nancy C. Brigdon
Nancy (), Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
K053367 510(k) Number:
Male Natural Rubber Latex Condom {No particular brand name] Device Name:
The [No particular brand name] condom is used for Indications For Use: THE [No particular STaprophylactic purposes (to help contraception and for proporty and the transmission of sexually transmitted diseases).
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109) OR
Over-The-Counter Use
Nancy Snvaton
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Deviçes 510(k) Number .
Counter Use