(46 days)
Not Found
No
The 510(k) summary describes a standard latex condom and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The intended use of the device is for contraception and prophylaxis to prevent pregnancy and sexually transmitted diseases, not for therapeutic purposes.
No
The device, a condom, is described as being used for contraception and prophylaxis (preventing pregnancy and STDs), not for diagnosing any medical condition.
No
The device description clearly states it is a "natural latex sheath," indicating a physical 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Thai Nippon condom is a physical barrier device used for contraception and disease prevention. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states its purpose is for contraception and prophylactic purposes, not for diagnostic testing.
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 Thai Nippon condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and transmission of sexually transmitted diseases).
Product codes
85 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-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. The condom is offered in natural latex color, red, blue, green, and yellow.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Suretex Latex Male Condom (K941258)
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
994095
Abbreviated 510 (k) for Male Latex Condoms
Page 5 of 13
| II. | 510(k) SUMMARY | JAN 1 8 2000 | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Submitted By: | Thai Nippon Rubber Industry, Ltd. | |||||||||||||||||||
| 49-49/1, EPZ-1 | ||||||||||||||||||||
| Laemchabang Industrial Estate | ||||||||||||||||||||
| Thungsukhla, Sriracha, Chonburi | ||||||||||||||||||||
| Thailand | ||||||||||||||||||||
| Telephone: 66-38-490258-9 | ||||||||||||||||||||
| Fax: 66-38-490414 | ||||||||||||||||||||
| Contact Persons: | Eli J. Carter | |||||||||||||||||||
| Consultant to Thai Nippon | ||||||||||||||||||||
| 1219 Little Creek Road | ||||||||||||||||||||
| Durham, NC 27713 |
Sandeep Parab
Manager QC/QA
Thai Nippon Rubber Industry Co. | | | | | | | | | | | | | | | | | | |
| | Date Prepared: | December 1, 1999 | | | | | | | | | | | | | | | | | | |
| | Proprietary Name: | No Specific Brand Name | | | | | | | | | | | | | | | | | | |
| | Common Name: | Latex Male Condom | | | | | | | | | | | | | | | | | | |
| | Classification: | Condom (21 CFR 884.5300) | | | | | | | | | | | | | | | | | | |
| | Predicate Device: | Suretex Latex Male Condom (K941258) | | | | | | | | | | | | | | | | | | |
| | 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-walled with a reservoir tip; nominal length 180-mm, nominal
width 52-mm, and nominal thickness 0.06mm. The condom is offered
in natural latex color, red, blue, green, and yellow. | | | | | | | | | | | | | | | | | | |
| | 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. | | | | | | | | | | | | | | | | | | |
| | 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. The follows provides a direct comparison to the predicate
device: | | | | | | | | | | | | | | | | | | |
| | | Feature One Touch Predicate Device Length (mm) 180 180 Width (mm) 52 52 Thickness (mm) 0.03 min. 0.03 min. Lubricant System Silicone Silicone Reservoir Tip Yes Yes | | | | | | | | | | | | | | | | | | |
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Thai Nippon Rubber Industry Co., Ltd. c/o Mr. Eli J. Carter Consultant to Thai Nippon Rubber 1219 Little Creek Road Durham, N.C. 27713
Re: K994095
One Touch™ Latex Condoms Dated: January 3, 2000 Received: January 10, 2000 Requiatory Class: II 21 CFR §884.5300/Procode: 85 HIS
Dear Mr. Carter:
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 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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT VII.
| 510(k) Number: | K994095 |
|---|---|
| Device Name: | Male Natural Rubber Latex Condom |
| Indications for Use: | The Thai Nippon condom is used for contraception and for |
| prophylactic purposes (to help prevent pregnancy and 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 (Optional Format 1 - 2 - ✓ ) |
|---|---|---|
| --------------------------------------- | ---- | --------------------------------------------------------------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K994095 |
|---|---|
| --------------- | --------- |