(259 days)
The [No particular brand name] condom is used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).
[No Particular Brand Name] Colored and/or Flavored Male Natural Rubber Latex Condom, 52mm or 56mm Nominal Width with Smooth or Dotted or Ribbed or 3 in 1 ( Dotted / Ribbed / Contoured) Surface Lubricated with Silicone Oil or Nonoxynol-9 Spermicide.
This document is a 510(k) clearance letter from the FDA for a conventional medical device (male latex condoms), not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies, standalone performance, ground truth for training data, etc.) is not applicable to this document.
The document discusses the substantial equivalence of the "Colored and Flavored Male Latex Condom (No Particular Brand Name)" to legally marketed predicate devices and mentions general controls provisions and specific labeling requirements for latex condoms (e.g., expiration dating per 21 CFR 801.435). However, it does not contain the kind of detailed study reports or performance metrics typically found for AI/ML device submissions.
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Image /page/0/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 three stripes forming its body and wing. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Koi-Yong Lim Director Pleasure Latex Products Sdn. Bhd. Lot 1365, 17th Miles Jalan Sungai Sembilang 45800 Jeram, MAYLASIA
JUN 2 3 2003
Re: K023333
Trade Name/Device: Colored and Flavored Male Latex Condom (No Particular Brand Name) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulation Number: 21 CFR 884.5310 Regulation Name: Condom with spermicidal lubricant Regulatory Class: II Product Code: 85 HIS and LTZ Dated: April 18, 2003 Received: April 21, 2003
Dear Mr. Lim:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to
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comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 8884.5300 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, 8801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 8801.435(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. 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/dsma/dsmamain.html".
Sincerely yours,
David R. Bergman
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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JUN 2 3 2003
VII. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K023333 |
|---|---|
| Device Name: | [No Particular Brand Name] Colored and/or Flavored Male Natural Rubber Latex Condom, 52mm or 56mm Nominal Width with Smooth or Dotted or Ribbed or 3 in 1 ( Dotted / Ribbed / Contoured) Surface Lubricated with Silicone Oil or Nonoxynol-9 Spermicide. |
| Indications For Use: | The [No particular brand name] condom is used for 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 IFConcurrence of CDRH, Office of Device Evaluation (ODE)
NEEDED)
Prescription Use (Per 21 CFR ß 801.109)
Over-The-Counter Use
er-The-Counter Use
David A. Legnon
OR
(Division Sign-Off) Division of Reprodu and Radiological D 510(k) Numb
| Labels | Values |
|---|---|
| ------------------------- | ------------------------- |
Page 14 of 14
§ 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.