(328 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical barrier made of latex, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is intended to reduce the risk of STD transmission, which is a prophylactic use, not a therapeutic (treatment) use.
No
The device is a barrier for preventing the transmission of sexually transmitted diseases. It does not diagnose any condition.
No
The device description clearly states it is a physical product made from natural rubber latex, not software.
Based on the provided text, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Glyde Dam Lollyes are described as a physical barrier made of latex intended for use during sexual activity to reduce the risk of transmitting STDs. They do not involve testing or analyzing bodily fluids or tissues in vitro.
- Intended Use: The intended use clearly states its purpose as a barrier during cunnilingus.
- Device Description: The description focuses on the physical properties and manufacturing of the latex sheet.
- Performance Studies: The performance studies mentioned (biocompatibility, tensile strength/elongation, virus) are related to the physical integrity and safety of the barrier, not diagnostic testing.
Therefore, the Glyde Dam Lollyes are a medical device, but they fall under a different category than In Vitro Diagnostics. They are a barrier method for preventing the transmission of STDs.
N/A
Intended Use / Indications for Use
Glyde Dam Lollyes Mare a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) ONLY, and are not intended for use during oral/anal sex.
Glyde Dam Lollyes™, when properly used, may help reduce the risk of catching or spreading many sexually transmitted diseases ("STDs") such as syphilis, gonorrhea, chlamydia infections, genital herpes and AIDS. However, they cannot eliminate the risk.
During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Glyde Dam Lollyes™ should be applied each and every time before any such contact occurs.
WARNING: DO NOT USE DURING PENETRATING PENILE/VAGINAL OR PENILE/ANAL INTERCOURSE.
WARNING: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS IN SOME INDIVIDUALS. IF YOU EXPERIENCE A REACTION. STOP USING THIS PRODUCT AND CONTACT YOUR PHYSICIAN.
Product codes
85 MSC
Device Description
Glyde Dam Lollyes are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Glyde Dam Lollyes is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (± 0.0006 millimeters.) Glyde Dam Lollyes are designed to be used while performing cunnilingus.
Qualification testing (biocompatibility, tensile strength/elongation, and virus) has been performed to satisfactorily conclude that Glyde Dam Lollyes operate as intended, when used properly. Finally, Glyde Dam Lollyes are tested for a smooth surface (i.e.: the presence of cracks and blisters,) and are visually tested for holes, tears, foreign materials and the like, during the manufacturing process of each lot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vulva, vaginal opening, clitoris
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
Non clinical testing: Biocompatibility, tensile strength/elongation and virus testing was performed on the Glyde Dam Lollyes. All testing was supportive of the claims (i.e.: indications for use.)
Key Metrics
Not Found
Predicate Device(s)
Trojan Brand Latex Condoms
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
510k Notification
lQH
CONFIDENTIAL
Image /page/0/Picture/3 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '970577'. The numbers are written in a bold, slightly irregular style, giving them a distinct, hand-drawn appearance.
JAN - 8 1998
APPENDIX E
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR GLYDE DAM LOLLYES
13 February 1997
Glyde USA, Inc. - Glyde Dam Lollyes™
E
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Confidential
11/2 -
Submitter
Glyde USA, Inc. 1758 Dexter Avenue North, Suite 3 Seattle, WA 98109 U.S.A.
Telephone Number: 206.283.7664
Facsimile: 206.284.7554
Contact Person: Barbara Lippert, President
Date summary was prepared
02.13.97
Name(s) of the device
Proprietary (Trade) Name: Glyde Dam Lollyes
Common or Usual Name: Latex dam
Identification of predicate device(s)
Trojan Brand Latex Condoms Carter Products, Division of Carter Wallace, Inc. New York, N. Y.
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510k Notification
Description of the device
Glyde Dam Lollyes are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Glyde Dam Lollyes is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (± 0.0006 millimeters.) Glyde Dam Lollyes are designed to be used while performing cunnilingus.
Qualification testing (biocompatibility, tensile strength/elongation, and virus) has been performed to satisfactorily conclude that Glyde Dam Lollyes operate as intended, when used properly. Finally, Glyde Dam Lollyes are tested for a smooth surface (i.e.: the presence of cracks and blisters,) and are visually tested for holes, tears, foreign materials and the like, during the manufacturing process of each lot.
Intended Use
Glyde Dam Lollyes, when properly used, may help reduce the risk of catching or spreading many Sexually Transmitted Diseases ("STDs") such as syphilis, gonorrhea, chlamydia infections, genital herpes, and AIDS; however, they cannot eliminate the risk. For maximum benefits, it is important to follow the instructions for use printed on the packaging. Failure to do so may result in the loss of the benefits of the Glyde Dam Lollyes. During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Glyde Dam Lollyes should be applied each and every time before any such contact occurs.
The Glyde Dam Lollyes is removed from the wrapper and laid flat. The Glyde Dam Lollyes is placed over the entire vulva, covering both the vaginal opening and the clitoris, while holding the ends of the Glyde Dam Lollyes. Optional: one side may be moistened with a commercially available water-based lubricant. The lubricated side of Dam Lollyes is then placed over the entire vulva, covering both the vaginal opening and the clitoris, while
3
holding the ends of the Glyde Dam Lollyes. The Glyde Dam Lollyes is intended for single use only. Users are instructed not to re-use Glyde Dam Lollyes because of possible crosscontamination. Users are further instructed not to stretch the Glyde Dam Lollyes, and instructed to store them in a cool dry place at room temperature (59 degrees to 86 degrees Fahrenheit) and away from direct exposure to sunlight.
Comparison of device characteristics to predicate
A comparison was made between the physical and performance characteristics of the Glyde Dam Lollyes and the physical and performance characteristics of a legally marketed predicate product. This analysis revealed that Glyde Dam Lollyes are substantially equivalent to that predicate product.
Non clinical testing
Biocompatibility, tensile strength/elongation and virus testing was performed on the Glyde Dam Lollyes. All testing was supportive of the claims (i.e.: indications for use.)
Conclusion
In conclusion, the basis for substantial equivalence between the Glyde Dam Lollyes and the legally marketed predicate product is that the products are predominantly similar and that the differences between the two products do not raise new issues of safety and effectiveness. Based upon the information provided herein, it is our conclusion that the Glyde Dam Lollyes are substantially equivalent to the Trojan Brand Condoms.
13 February 1997 Glyde USA, Inc. - Glyde Dam Lollyes™
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 1998
Glyde USA, Inc. c/o Ms. Louise C. Myers Technical Adviser Medical Technology Consultants 14808 N.E. 66th Street Redmond, Washington 98052-4712 Re: K970577
Glyde Dam Lollyes™ Dated: October 21, 1997 Received: October 23, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 MSC
Dear Ms. Myers:
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 stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 requirement, 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 question 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-momber (800) 636-2041 or " (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
510(k) Number
Device Name
Glyde Dam Lollyes
Indications for Use
Glyde Dam Lollyes Mare a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) ONLY, and are not intended for use during oral/anal sex.
Glyde Dam Lollyes™, when properly used, may help reduce the risk of catching or spreading many sexually transmitted diseases ("STDs") such as syphilis, gonorrhea, chlamydia infections, genital herpes and AIDS. However, they cannot eliminate the risk.
During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Glyde Dam Lollyes™ should be applied each and every time before any such contact occurs.
WARNING: DO NOT USE DURING PENETRATING PENILE/VAGINAL OR PENILE/ANAL INTERCOURSE.
WARNING: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS IN SOME INDIVIDUALS. IF YOU EXPERIENCE A REACTION. STOP USING THIS PRODUCT AND CONTACT YOUR PHYSICIAN.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over-the Counter Use
Robert D. Sather/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970151