(252 days)
Not Found
No
The summary describes a standard latex condom and makes no mention of AI or ML technology.
No
The device is described as being for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease), which are preventative rather than therapeutic in nature.
No
The device is described as a condom used for contraception and prophylactic purposes, not for diagnosing any medical condition.
No
The device description clearly states it is a physical condom made of latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Durex latex condom is a barrier device used on the body (in vivo) for contraception and disease prevention. It does not perform any tests on bodily samples.
- Intended Use: The stated intended use is for contraception and prophylactic purposes, not for diagnosing any condition or analyzing bodily fluids.
Therefore, based on the provided information, the Durex latex condom is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Product codes (comma separated list FDA assigned to the subject device)
85 HIS
Device Description
This condom is made of a natural rubber colored latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, flavored condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492. The condom is offered in Chocolate, Chocolate/coconut. Chocolate/peppermint, and Chocolate/orange.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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
Durex Flavored Latex Condom Premarket approval [510(k)]
Section II Summary
A. Submitter Information
SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 – 582 – 2222 Fax: 770 — 582 — 2233
B. Contact Person
Kathleen Harris, Requlatory Affairs Manager, SSL Americas
C. Date Prepared July 11, 2003
D. Proprietary Name Durex Flavored Latex Condom
E. Common Name
Latex Condom
F. Classification Name
Condom (21 CFR 884.5300)
G. Predicated Device
Natural and Colored Condoms with Flavors [510(k) Number K020633] One Touch (or private label) Flavored Male Latex Condom [510(k) Number K011253]
Durex Lubragel Latex Rubber Condom [510(k) Number K983380]
H. Description of the Device
This condom is made of a natural rubber colored latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, flavored condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492. The condom is offered in Chocolate, Chocolate/coconut. Chocolate/peppermint, and Chocolate/orange.
1
Durex Flavored Latex Condom Premarket approval [510(k)]
I. Intended Use of the Device
This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
J. Technological Characteristics
This condom has the same technological characteristics as the predicate condoms identified. The LS Rubber SDN and Thai Nippon Rubber Industry products are manufactured of natural rubber latex with flavor additives in lubricant . The Durex Lubragel product is the same condom and base lubricant as the product submitted in this 510(k). The condom design conforms to domestic and international regulations: ASTM D3492, ISO 4074 and EN 600. All physical testing and final release testing revealed results in conformance with required specifications.
2
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized, curved lines that appear to be flowing or moving upwards. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2004
Ms. Kathleen Harris Regulatory Affairs Manager SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214
Re: K032227
Trade Name/Device: Durex flavored Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: 85 HIS Dated: January 6, 2004 Received: January 8, 2004
Dear Ms. Harris:
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 QS 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.
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
3
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(j) 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. 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,
Nancy C. Brogdon
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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Indications for Use
510(k) Number (if known): K032227
Device Name:___ Durex flavored natural rubber latex condom
Indications For Use: Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Prescription Use
AND/OR
Over-The-Counter Use X
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033227
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