(42 days)
No
The device description and intended use clearly describe a physical barrier made of latex. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No.
The primary purpose of this device is to act as a physical barrier to reduce the risk of STD transmission during oral sexual contact, rather than to treat or cure a disease or condition.
No
Explanation: The device is described as a barrier to reduce the transmission of STDs during oral sex, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical product made of natural rubber latex and describes its dimensions and manufacturing process. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Sheer Glyde Dams™ Function: Sheer Glyde Dams™ are a physical barrier designed to prevent the transmission of STDs during oral sex. They do not analyze any bodily fluids or provide diagnostic information. Their function is purely mechanical and preventative.
The description clearly states their intended use is as a barrier during sexual activity, not for testing or analyzing biological samples.
N/A
Intended Use / Indications for Use
Sheer Glyde Dams™ are a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) or anilingus (oral/anal sex [rimming]).
Sheer Glyde Dams™, 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 Sheer Glyde Dams™ 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
Sheer Glyde Dams™ are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Sheer Glyde Dams™ is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (+ 0.0006 millimeters.) Sheer Glyde Dams™ are designed to be used while performing either cunnilingus or anilingus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vulva, vaginal opening, clitoris, anal area, anus
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)
Qualification testing (biocompatibility, tensile strength/elongation, and virus) was previously performed to satisfactorily conclude that Sheer Glyde Dams™ operate as intended, when used properly. Finally, Sheer Glyde Dams™ 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.
Non clinical testing: Biocompatibility, tensile strength/elongation and virus testing was performed on the Sheer Glyde Dams™as part of the original 510(k) Notification process. No additional testing is required as a result of the addition of the new indication for use. Testing is supportive of the new claim (i.e.: indication for use.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
2 19/99
APPENDIX E
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR SHEER GLYDE DAMS™
1
K990067
Submitter
1
Glyde USA, Inc. 1758 Dexter Avenue North, Suite 3 Seattle, WA 98109 U.S.A.
Telephone Number: 206.283.7664
Facsimile Number: 206.284.7554
Contact Person: Barbara Lippert
Contact Title: President
Date summary was prepared
01.07.99
Name(s) of the device
Proprietary (Trade) Name: Sheer Glyde Dams™
Common or Usual Name: Latex dam
ldentification of predicate device(s)
Sheer Glyde Dams™ (previously named "Glyde Dam Lollyes™)
2
Description of the device
K990067
Note: There has been no change to the materials that comprise the product, or to the manufacturing or quality assurance processes: Sheer Glyde Dams™ are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Sheer Glyde Dams™ is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (+ 0.0006 millimeters.) Sheer Glyde Dams™ are designed to be used while performing either cunnilingus or anilingus.
Qualification testing (biocompatibility, tensile strength/elongation, and virus) was previously performed to satisfactorily conclude that Sheer Glyde Dams™ operate as intended, when used properly. Finally, Sheer Glyde Dams™ 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
Sheer Glyde Dams™, 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 Sheer Glyde Dams™. During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Sheer Glyde Dams™ should be applied each and every time before any such contact occurs.
The Sheer Glyde Dams™ is removed from the wrapper and laid flat. The Sheer Glyde Dams™ is placed over the entire vulva, covering both the vaginal opening and the clitoris, or alternatively, over the entire anal area, including anus, while holding the ends of the Sheer Glyde Dams™. Optional: one side may be moistened with a commercially available water-based lubricant. The lubricated side of Sheer Glyde Dams™ is then placed over the entire vulva, covering both the vaginal opening and the clitoris, or alternatively, over the
3
entire anal area, including anus, while holding the ends of the Sheer Glyde Dams™. The Sheer Glyde Dams™ is intended for single use only. Users are instructed not to re-use Sheer Glyde Dams™ because of possible cross-contamination, and they are instructed to use a separate and new Sheer Glyde Dams™ for the vaginal area and the anal area. Users are further instructed not to stretch the Sheer Glyde Dams™, 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 Sheer Glyde Dams™ and the legally marketed predicate product (Sheer Glyde Dams™). There has been no change in any of the material or performance characteristics. The only change is an addition to the indications for use of the product: during anilingus. Sheer Glyde Dams™ are substantially equivalent to the predicate product.
Non clinical testing
Biocompatibility, tensile strength/elongation and virus testing was performed on the Sheer Glyde Dams™as part of the original 510(k) Notification process. No additional testing is required as a result of the addition of the new indication for use. Testing is supportive of the new claim (i.e.: indication for use.)
Conclusion
In conclusion, the basis for substantial equivalence between the Sheer Glyde Dams™ and the legally marketed predicate product (Sheer Glyde Dams™) is that the products are identical, with the only difference being an added indication for use: namely, anilingus. This new indication for use does not raise new issues of safety and effectiveness. Based upon the information provided herein, it is our conclusion that the Sheer Glyde Dams™ are substantially equivalent to the currently marketed predicate product.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1999
Glyde USA, Inc. c/o Ms. Louise C. Myers Regulatory and Clinical Consultant 14808 N.E. 66th Street Redmond. WA 98052-4712
Re: K990067
Sheer Glyde Dams™ Dated: January 7, 1999 Received: January 8, 1999 Regulatory Class: II 21 CFR 884.5300/Procode: 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 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 maior requlations affecting your device can be found in the Code of Federal Requirations. 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 (QS) 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.
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 requlation (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 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 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,
.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number
None assigned to date.
Device Name
Sheer Glyde Dams™
Indications for Use
Sheer Glyde Dams™ are a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) or anilingus (oral/anal sex [rimming]).
Sheer Glyde Dams™, 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 Sheer Glyde Dams™ 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)
1
Over-the Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number