(135 days)
Not Found
No
The 510(k) summary describes a standard latex condom and does not mention any AI or ML components or functionalities.
No
The device is described as a condom used for contraception and the prevention of sexually transmitted diseases, which are prophylactic rather than therapeutic purposes (treatment or healing).
No
Explanation: The device, a latex condom, is described as being used for contraception and prophylactic purposes to prevent pregnancy and the transmission of sexually transmitted diseases. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states it is a latex condom, which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The description clearly states that this device is a latex condom used for contraception and prophylactic purposes to prevent pregnancy and the transmission of sexually transmitted diseases. It is a physical barrier device applied externally to the penis.
- Lack of Diagnostic Testing: There is no mention of this device performing any kind of test on a biological sample to provide diagnostic information. Its function is purely mechanical and preventative.
Therefore, based on the provided information, this device falls under the category of a medical device, but specifically a barrier contraceptive/prophylactic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
"This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc."
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
"This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip. Its nominal length is 185 - 190 mm, nominal width 50.5 -51.5 mm, and nominal thickness 0.06 - 0.08 mm. It is offered in natural latex color and lubricated with polydimethylsiloxane (silicone) with cornstarch as the dressing material. This condom is designed to conform to established American and international voluntary standards including ASTM D3492 and ISO 4074."
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
KD80833
Abbreviated 510(k) for "Love Guard" Male Latex Condom
510(K) Summary for "Love Guard" Male Latex Condoms
AUG - 7 2008
| Submitted by: | Tianjin Human-care Latex Corporation
No 223, West 14 Road
Tianjin Airport Industrial Park
300308 Tianjin
People's Republic of China
Tel: 86-22-6045-7598
Fax: 86-22-6045-7578 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Pine Stone
Director, International Trade Department
Tianjin Human-care Latex Corporation
No 223, West 14 Road
Tianjin Airport Industrial Park
300308 Tianjin
People's Republic of China
Office phone: 86-22-6045-7598 |
| Date Revised: | July 31st 2008 |
| Proprietary Name: | "Love Guard" Male Latex Condom |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom (21 CFR §884.5300) |
| Predicate Device: | "Lifestyles" Male Latex Condom
Ansell Healthcare Products, LLC
510(k) Document Control Number: K010371 |
Description of the Device: This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip. Its nominal length is 185 - 190 mm, nominal width 50.5 -51.5 mm, and nominal thickness 0.06 - 0.08 mm. It is offered in natural latex color and lubricated with polydimethylsiloxane (silicone) with cornstarch as the
1
dressing material. This condom is designed to conform to established American and international voluntary standards including ASTM D3492 and ISO 4074.
- Intended Use of the Device: This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.
- Technological Characteristics: This condom has the same technological characteristics as the predicate condom identified above. This condom is made of natural latex. Its design is in conformance with ASTM Latex Condom Standard D3492. The "Love Guard" Male Latex Condom to be introduced to the US market is similar to the predicate device in terms of the intended use, method of operation, materials, design, etc. Therefore, there is no significant difference between the "Love Guard" Male Latex Condom and the predicate device in the areas of safety and effectiveness.
| Features | "Love Guard" Condom | "Lifestyles" Condom |
|---|---|---|
| Length (mm) | 185 - 190 | 182 -190 |
| Width (mm) | 50.5 - 51.5 | 51 - 52 |
| Thickness (mm) | 0.06 - 0.08 | 0.05 |
| Air burst pressure (kPa) | 1.35 - 2.55 | 0 - 2.85 |
| Air burst volume (dm³) | 20.0 - 58.5 | 0 - 47 |
| Package materials | Aluminum foil | Aluminum foil |
| Lubricant system | Polydimethylsiloxane (silicone) | |
| Viscosity: 300 mPa.S | Glycerin-based | |
| Dusting agent | Cornstarch | Cornstarch |
| Reservoir tip | Yes | Yes |
The similarities of the features and technological characteristics of "Love Guard" Male Latex Condom in comparison to the predicate condom are summarized as follows:
2
510(K) Summary for "Love Guard" Male Latex Condoms
| Submitted by: | Tianjin Human-care Latex Corporation
No 223, West 14 Road
Tianjin Airport Industrial Park
300308 Tianjin
People's Republic of China
Tel: 86-22-6045-7598
Fax: 86-22-6045-7578 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Pine Stone
Director, International Trade Department
Tianjin Human-care Latex Corporation
No 223, West 14 Road
Tianjin Airport Industrial Park
300308 Tianjin
People's Republic of China
Office phone: 86-22-6045-7598 |
| Date Revised: | July 31st 2008 |
| Proprietary Name: | "Love Guard" Male Latex Condom |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom (21 CFR §884.5300) |
| Predicate Device: | "Lifestyles" Male Latex Condom
Ansell Healthcare Products, LLC
510(k) Document Control Number: K010371 |
Description of the Device: This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip. Its nominal length is 185 - 190 mm, nominal width 50.5 -51.5 mm, and nominal thickness 0.06 - 0.08 mm. It is offered in natural latex color and lubricated with polydimethylsiloxane (silicone) with cornstarch as the
3
dressing material. This condom is designed to conform to established American and international voluntary standards including ASTM D3492 and ISO 4074.
- Intended Use of the Device: This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.
- Technological Characteristics: This condom has the same technological characteristics as the predicate condom identified above. This condom is made of natural latex. Its design is in conformance with ASTM Latex Condom Standard D3492. The "Love Guard" Male Latex Condom to be introduced to the US market is similar to the predicate device in terms of the intended use, method of operation, materials, design, etc. Therefore, there is no significant difference between the "Love Guard" Male Latex Condom and the predicate device in the areas of safety and effectiveness.
| Features | "Love Guard" Condom | "Lifestyles" Condom |
|---|---|---|
| Length (mm) | 185 - 190 | 182 -190 |
| Width (mm) | 50.5 - 51.5 | 51 - 52 |
| Thickness (mm) | 0.06 - 0.08 | 0.05 |
| Air burst pressure (kPa) | 1.35 - 2.55 | 0 - 2.85 |
| Air burst volume (dm³) | 20.0 - 58.5 | 0 - 47 |
| Package materials | Aluminum foil | Aluminum foil |
| Lubricant system | Polydimethylsiloxane (silicone) | |
| Viscosity: 300 mPa.S | Glycerin-based | |
| Dusting agent | Cornstarch | Cornstarch |
| Reservoir tip | Yes | Yes |
The similarities of the features and technological characteristics of "Love Guard" Male Latex Condom in comparison to the predicate condom are summarized as follows:
4
K080833
INDICATIONS FOR USE STATEMENT VII.
510(k) Number:
"Love Guard" Male Latex Condom Device Name:
Indication For Use: This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2008
Tianjin Human-Care Latex Corporation c/o Simon Li, MD, PhD Lift International, Inc. 56 Danville Drive WEST WINDSOR NI 08550
Re: K080833
Trade Name: "Love Guard" Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Male Latex Condom Regulatory Class: II Product Code: HIS Dated: June 10, 2008 Received: June 12, 2008
Dear Dr. Li:
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.
6
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 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), please contact the Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 Manufacturers, 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/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K 080833
INDICATIONS FOR USE STATEMENT VII.
510(k) Number:
"Love Guard" Male Latex Condom Device Name:
Indication For Use: This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ X
Hula Lemen
ivision Sign-Off Division of Reproductive. Abdomin and Radiological D 510(k) Number