(65 days)
Not Found
No
The device description and intended use are for a standard latex condom, and there is no mention of AI or ML in the provided text.
No
The device is described as being used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases), not for treating an existing disease or condition.
No
Explanation: The device is a male latex condom used for contraceptive and prophylactic (prevention of STDs) purposes. It is explicitly described as a physical barrier for prevention, not for detecting or diagnosing any medical condition.
No
The device description clearly describes a physical product made of latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a male latex condom used for contraception and preventing the transmission of STDs. It is a physical barrier device applied externally to the body.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens.
Therefore, based on the provided information, this device falls under the category of a medical device, but specifically not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NRS Global Partners male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Product codes
HIS
Device Description
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight sided, contoured or flared in shape, either textured or non-textured, with a reservoir tip; nominal length 180-mm, nominal width 53-mm, and nominal thickness 0.07mm. It is lubricated with silicone or Astroglide™, and USP grade cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
This condom is identical to the predicate device with respect to design, physical properties, and formulation.
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)
Reference Device(s)
Not Found
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
Abbreviated 510 (k) Notification for a Male Latex Condom
APR 8
2005
Page 5 of 13
| 510(k) SUMMARY | |
|---|---|
| Submitted By: | NRS Global Partners Sdn Bhd |
| No. 30, Jalan 3/146, Bandar Tasik Selatan | |
| 5700 Kuala Lumpur, Malaysia | |
| Contact Persons: | Eli J. Carter, Consultant |
| 1219 Little Creek Road | |
| Durham, NC 27713 | |
| Mr. Anthony Tan Jian Loong | |
| Chief Operating Officer | |
| NRS Global Partners Shn Bhd | |
| Date Prepared: | January 31, 2005 |
| Proprietary Name: | None |
| Common Name: | Male Latex Condom |
| Classification Name: | Male Latex Condom |
| Predicate Device: | Innolatex Male Latex Condom; K002393 |
| Description of Device: | This condom is made of a natural latex sheath, which completely |
| covers the erect penis with a closely fitted membrane. This condom is | |
| straight sided, contoured or flared in shape, either textured or non- | |
| textured, with a reservoir tip; nominal length 180-mm, nominal width | |
| 53-mm, and nominal thickness 0.07mm. It is lubricated with silicone | |
| or Astroglide™, and USP grade cornstarch is used as a dressing | |
| material. This condom is designed to conform to established national | |
| and international voluntary standards including ASTM D3492 and ISO |
- |
| | This condom is identical to the predicate device with respect to
design, physical properties, and formulation. |
| 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 purposes to
help prevent pregnancy and the transmission of sexually transmitted
diseases, including HIV. |
| Technological Characteristics: | This condom has the same technological characteristics as the predicate
condom identified above. The design is in conformance with ASTM
Latex Condom Standard D3492 and that the condom is made of natural
rubber latex. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NRS Global Partners Sdn Bhd % Mr. Eli Carter Consultant 1219 Little Creek Rd. DURHAM NC 27713
Re: K050244
2005
APR 8
Trade/Device Name: Male Natural Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 31, 2005 Received: February 4, 2005
Dear Mr. Carter:
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.
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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your finding of substantial equivalence of your device to a legally promated modicate 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 11 you done 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
Page 11 of 13
INDICATIONS FOR USE
| 510(k) Number: | Not Known K050244 |
|---|---|
| Device Name: | Male Natural Rubber Latex Condom |
| Indications for Use: | The NRS Global Partners male latex condom is used for contraceptive |
| and for prophylactic purposes (to help prevent pregnancy and the | |
| transmission of sexually transmitted diseases) |
Prescription Use (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (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)
Nancy C Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, And Radiological Devices
510(k) Number K050244