(90 days)
The [No varticular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Male Natural Rubber Latex Condom [No particular brand name]
The provided text is an FDA 510(k) clearance letter for a Male Latex Condom and does not contain the detailed information required to answer your request regarding acceptance criteria and study particulars for a medical device's performance.
Specifically, the document:
- Approves the device as substantially equivalent to a predicate device.
- Mentions regulatory class, applicable CFR sections, and general controls.
- Discusses labeling requirements for latex condoms, including expiration dating and real-time test data.
- States the Indications For Use.
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any specific test set.
- Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- The type of ground truth used, training set sample size, or how ground truth was established for a training set.
This type of information is typically found in the 510(k) submission itself (which often includes summary data and test reports), not in the FDA's clearance letter. The clearance letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of three overlapping human figures, possibly representing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2000
Mr. Lim Koi Yong Director Pleasure Latex Products Sdn. Bhd. Lot 1365, 17th Miles Jalan Sungai Sembilang 45800 Jeram Selangor Darul Ehsan Malaysia
Re: K994312
Male Latex Condom, 56 mm width Dated: December 16, 1999 Received: December 22, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS
Dear Mr. Yong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might
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MAR 2 1 2000
Page 2 - Mr. Lim Koi Yong
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(i) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or (301) 443-6597,or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Umid C. Lynn
fsr
Daniel G. Schultz, M.D. Captain, USPHS 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 STATEMENT VII
K994312 510(k) Number:
Male Natural Rubber Latex Condom [No particular brand name] Device Name:
The [No varticular brand name] condom is used for Indications For Use: contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801 109)
OR
Over-The-Counter Use
Daniel G. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, E and Radiological Devi-510(k) Number
§ 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.