(537 days)
"Erozone" personal lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
"Erozone" is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. "Erozone" Personal Lubricants may be used with condoms.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Erozone" Glide Fluid, which is classified as a condom (21 CFR 884.5300). The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-based medical device. Therefore, I cannot provide the requested information. The content is an FDA approval letter for a physical product, a lubricant, not a software device that would typically have acceptance criteria, test sets, ground truth, or MRMC studies as described in your prompt.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
R & C International Cosmetics % Mr. Gary L. Lotridge Baise & Miller, P.C. P.O. Box 14368 Ben Franklin Station WASHINGTON DC 20044-4368 Re: K040428
AUG 9 - 2005
Trade/Device Name: "Erozone" Glide Fluid Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 21, 2005 Received: July 26, 2005
Dear Mr. Lotridge:
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 (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 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. 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
11) in the first for the support of a location at which aggivelence of your devi This letter will allow you to begin marketing your antine of your device of your device to a legally
premarket notification. The FDA inding of substantial equivalence of you premarket notification. The FDA Inding of Substantial of 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 Patt 801), pleased
en the same If you desire specific advice for your device on our labering regarities. (1).
contact the Office of Compliance at one of the following numbers, based on the regulation numbe 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" (21 CFR Also, please note the regulation entitled, "Misonaliante of tesponsibilities under the Act from the 807.97). You may obtain other geticial information of Not. Four respections
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (8 DIVISIOn of Small Man-6597 or at its Internet address 038-2041 of (2017) 115-05-2047 of 15-05-2041 11:11:11
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040428
"Erozone" Glide Fluid Device Name:
Indications For Use:
:
"Erozone" personal lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
"Erozone" is recommended as a personal lubricant to enhance intimate It is designed to help enhance the sexual experience by providing activities. supplemental vaginal lubrication during sexual intercourse. "Erozone" Personal Lubricants may be used with condoms.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hogdon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number .
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§ 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.