(77 days)
Not Found
No
The 510(k) summary describes a standard condom and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance studies typically associated with AI/ML devices.
No
The primary stated uses are contraception and preventing the transmission of sexually transmitted diseases, which are prophylactic and preventive, not therapeutic.
No
The device description and intended use clearly state that the condom is for contraception and prophylactic purposes (preventing pregnancy and STDs), not for diagnosing any condition.
No
The device description clearly states it is a physical condom made of natural rubber, 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.
- Condom Function: The intended use of this condom is for contraception and preventing the transmission of sexually transmitted diseases. It acts as a physical barrier and does not perform any diagnostic tests on bodily samples.
- Lack of Diagnostic Elements: The device description focuses on the physical characteristics of the condom (material, shape, dimensions). There are no mentions of reagents, test strips, analyzers, or any other components typically associated with IVD devices.
Therefore, based on the provided information, this condom is a medical device, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 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 sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth or textured surface, parallel-sided ,reservoir ended condoms with an integral bead at the open end. The nominal length is minimum 180 mm, the width is 52 or 53 +/- 2 mm and 0.03 mm minimum for the thickness.
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
MAY 1 5 2002
S RUBBER SDN. BHD. (247757-A)
PLO 22, Senai Industrial Estate, Phase 1, 81400 Senai, Johor, Malaysia. r LG 22, Sonal Industhana) Fax : 607-599 3797 E-mail: Isrsb@po.jaring.my
Abbreviated 510(k) for Male Condoms
Page 4 of 12
- NOTE : Provide the information required by 21 CFR 807.92, content and Format for a 510(k) summary (Option 1), below OR the 510(k) Statement (Option 2) on the next page.
- 510(k) SUMMARY (Option I) 11. [Refer to 21 CFR. 807.92]
Submitted by:
LS Rubber Sdn. Bhd Plo 22, Senai Industrial Estate, Phase 1, 81400 Senai, Johor.
607-5993923.
Mariza Marzih Contact Person :
25th October, 2001. Date Prepared :
Natural Rubber Latex Condoms. Proprietary Name:
Latex Condom Common Name :
Condom (21 CFR 884.5300) Classification :
Natural and colored latex condoms with flavors. Predicate Device :
- Description of the Device : This condom is made of a natural rubber sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth or textured surface, parallel-sided ,reservoir ended condoms with an integral bead at the open end. The nominal length is minimum 180 mm, the width is 52 or 53 +/- 2 mm and 0.03 mm minimum for the thickness.
Intended Use of The Devices : 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 : The condom has the same technological characteristic as the predicate condom 510(K) # K980964. The only modification is to delete the brand names present in the 510(K) # K980964 and to add the new flavors which are approved by the Food and Drug Authority USA and listed in the FEMA GRAS list.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is written in a simple, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms.• Mariza Marzih LS Rubber SDN.BHD. PLO 22, Senai Industrial Estate Phase 1, 81400 Senai, Johor MALAYSIA
Re: K020633
Trade Name/Device: Natural & Colored Condoms with Flavors Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: April 23, 2002 Received: April 30, 2002
Dear Ms. Marzih:
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 vour 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.
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.
2
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 §884.5300 and 8884.5310) 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. 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. 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 G. Ingram
fr
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
L S RUBBER SDN. BHD. (2477557-A)
PLO 22, Senai Industrial Estate, Phase 1, 81400 Senai, Johor, Malaysia. Tel : 607-599 3923 (5 Lines) Fax : 607-599 3797 E-mail: Isrsb@po.jaring.my
Information for a Male Latex Condom 510(k) Submission
Page 11 of
VII. INDICATIONS FOR USE STATEMENTS
(020633 510(k) Number:
Colored Latex Condom with Flavored Lubricant. Device Name:
The condom is used for contraception and for Indications For Use: Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thavid li. Seymon
OR
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109) over-the-counter Use