Non-spermicidal Lubricated Male Latex Condom
Device Facts
| Record ID | K193578 |
|---|---|
| Device Name | Non-spermicidal Lubricated Male Latex Condom |
| Applicant | Global Protection Corp. |
| Product Code | HIS · Obstetrics/Gynecology |
| Decision Date | Aug 20, 2020 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Intended Use
Non-spermicidal Lubricated Male Latex Condoms are intended to prevent pregnancy, HIV/AIDS and other sexually transmitted infections.
Device Story
Non-spermicidal lubricated male latex condom; physical barrier device; intended for over-the-counter use to prevent pregnancy and sexually transmitted infections (STIs), including HIV/AIDS. Device functions as a mechanical barrier during sexual intercourse. No electronic, software, or algorithmic components.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Material: Latex rubber. Form factor: Male condom. Lubricant: Non-spermicidal. Sterilization: Not specified. No electronic components, software, or energy sources.
Indications for Use
Indicated for use by individuals to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
Regulatory Classification
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.
Special Controls
*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.
Related Devices
- K023128 — NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM · Secure Scientific Sdn Bhd · Jan 22, 2003
- K024324 — LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 · Global Protection Corp. · Mar 25, 2003
- K971028 — WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED · Worlds-Best Gummivarefabrik A/S · Mar 2, 1998
- K980319 — DUREX ULTRA COMFORT · London Intl., LLC · May 20, 1998
- K012665 — ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT · Innolatex Sdn. Bhd · Nov 9, 2001
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 20, 2020
Global Protection Corp. Christina Cataldo RA/OA Manager 12 Channel Street Boston, MA 02210
Re: K193578
> Trade/Device Name: Non-spermicidal Lubricated Male Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: July 21, 2020 Received: July 23, 2020
Dear Christina Cataldo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K193578
Device Name
Non-spermicidal Lubricated Male Latex Condom
Indications for Use (Describe)
Non-spermicidal Lubricated Male Latex Condoms are intended to prevent pregnancy, HIV/AIDS and other sexually transmitted infections.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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