(219 days)
Not Found
No
The device description is for a standard condom and there is no mention of AI or ML in the provided text.
No
This device is a condom, used for contraception and prevention of STDs, which are not considered therapeutic purposes.
No
The device description indicates that it is a condom used for contraception and prevention of sexually transmitted diseases. It does not mention any diagnostic capabilities.
No
The device description clearly states it is a physical condom made of natural rubber latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of STDs. This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description details a physical barrier device (a condom) and its physical characteristics. It doesn't describe reagents, instruments, or procedures for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Diagnostic or monitoring purposes related to a disease or condition.
The device is clearly a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Karex condom is used for contraceptive and for Prophylactic purposes { to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight sided or contoured , textured or non textured ,with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.07mm. It is nonlubricated or lubricated with silicone and cornstarch is used as a dressing material. The condom is either colored or non colored, flavored or non flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
Condoms will be offered in the following Color and Flavor. Combinations : Color Flavor
- Yellow Banana
- Red Strawberry
- Green Mint
- Brown Chocolate
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.
K012962, K010919, K053367, K070830, K002060
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.
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FEB - 6 2009
Page 5 of 22
1081886
Abbreviated 510(k) Notification for a Male Latex condom
II 510(k) SUMMARY
Submitted by :
Karex Industries Sdn. Bhd. PTD. 7906 & 7907 Taman Pontian Jaya, Bt. 34 Jalan Johor, 82000 Pontian, Johor, Malaysia.
Mr. Leng Kian Goh
Karex Industries Sdn. Bhd.
E-mail: Ik(@karex.com.my
General Manager
December 9, 2008.
Contact Persons :
Date Prepared :
Proprietary Name :
Common Name : Male Latex Condom
N/A.
Classification Name : Male latex Condom
Predicate Devices :
Latex Lubricated Condom Innolatex Sdn. Bhd. 510(k) Number = K012962 510(k) Number = K010919 510(k) Number = K053367
(Dotted Condoms) (Ribbed Condoms) (Non Lubricated Condoms)
Mary Goh
Quality Assurance Manager
Karex Industries Sdn. Bhd.
Karex Industries Sdn. Bhd. 510(k) Number=K070830
(Colored and Flavored Condoms)
Dongkuk Techco Rubber Industries 510(k) Number = K002060 (Ribbed, Dotted & Contoured)
1
Description of Device:
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight sided or contoured , textured or non textured ,with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.07mm. It is nonlubricated or lubricated with silicone and cornstarch is used as a dressing material. The condom is either colored or non colored, flavored or non flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
Condoms will be offered in the following Color and Flavor. Combinations : Color Flavor
| 1. | Yellow | Banana |
|---|---|---|
| 2. | Red | Strawberry |
| 3. | Green | Mint |
| 4. | Brown | Chocolate |
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, including HIV.
Technological Characteristics:
This condom has the same technological characteristics as the predicate condoms identified above. The following Table provides a description of these colors and flavorings. The design of this condom is in conformance with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex.
| Color Pigments | CI No. | CAS No. |
|---|---|---|
| Colanyl Yellow FGL 130 | 11767 | 12225-21-7 |
| Colany! Red FGRG 100 | 15850: 1 | N/A |
| Colanyl Green GG 131 | 77260 | 12001-99-9 |
| Colanyl Brown BM 100-ID | 77499 | 1317-61-9 |
2
Flavorings
Description
Banana Strawberry Mint Chocolate
Banana Flavor Concentrate #8500 Strawberry Flavor Concentrate # 4837 Peppermint Flavor Oil #4608 Chocolate Flavor Oil # 2141
The base formula was evaluated and confirmed to be in conformance with ISO 10993 biocompatibility requirements for cytotoxicity, and sensitization. The color pigments and flavorings have also been evaluated as part of the Predicate Device formulations and have been confirmed to be compliant with ISO 10993; and compliant with acceptable limits for oral toxicity.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble human figures or flowing lines. The emblem is black, and the text is also in black.
FEB - 6 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Goh QA Manager Karex Industries SDN. BHD. PTD. 7906 & 7907 Taman Pontian Jaya Bt. 34 Jalan Johor, 82000 Pontian, Johor MALAYSIA
Re: K081886
Trade/Device Name: Male Natural Rubber Latex Condom
(Straight sided or Contoured in shape, either Textured or Non-Textured, Lubricated or Non-Lubricated, Non-colored or Colored and Flavored or Non-Flavored)
Regulation Number: 21 CFR §884.5300
Regulation Narne: Condom Regulatory Class: II Product Code: HIS Dated: January 22, 2009 Received: January 26, 2009
Dear Ms. Goh:
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 (PMA), 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.
4
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Abbreviated 510(k) Notification for a Male latex Condom
INDICATIONS FOR USE STATEMENT VII
510(k) Number K081886
Device Name
Male Natural Rubber Latex Condom . (Straight sided or Contoured in shape, either Textured or Non-Textured, Lubricated or Non-Lubricated, Non-colored or Colored and Flavored or Non-Flavored).
Indications for Use:
Indications for Use: The Karex condom is used for contraceptive 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 NEED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
X
Arzu K. Wum
(Division Sign-Off) Division of Reproductive. Abdominal. and Radiological Devi
510(k) Number.