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.

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.

AI/ML Overview

This document describes a 510(k) submission for "Glyde Dam Lollyes," a latex dental dam. The submission focuses on demonstrating substantial equivalence to a predicate device (Trojan Brand Latex Condoms) rather than a direct clinical performance study with acceptance criteria for a novel medical device. Therefore, a direct table of acceptance criteria and reported device performance, and information typically associated with a clinical study (sample size, expert ground truth, MRMC study, standalone performance) for an AI/device, are not present in this document.

However, based on the provided text, I can extract information relevant to the device's "acceptance criteria" in the context of a 510(k) submission for substantial equivalence, and the tests performed to support that claim.

Acceptance Criteria and Reported Device Performance (in the context of 510(k) Substantial Equivalence)

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance (Glyde Dam Lollyes)	Outcome
Material Conformance	ASTM 1076-88	Manufactured from good quality rubber latex conforming to ASTM 1076-88	Met
Physical Dimensions	Size: 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch)	10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch)	Met
Thickness	Thickness: 0.08 mm (± 0.0006 mm)	0.08 millimeters thick (± 0.0006 millimeters)	Met
Biocompatibility	Acceptable safety profile for human contact	Qualification testing performed	Supportive of claims
Tensile Strength/Elongation	Mechanical integrity for intended use	Qualification testing performed	Supportive of claims
Virus Barrier	Efficacy as a barrier against viruses	Qualification testing performed	Supportive of claims
Surface Smoothness	Absence of cracks and blisters	Tested for smooth surface (i.e.: the presence of cracks and blisters) during manufacturing	Met
Visual Inspection	Absence of holes, tears, foreign materials	Visually tested for holes, tears, foreign materials and the like during manufacturing	Met

Note: The "acceptance criteria" here are aligned with demonstrating substantial equivalence to a legally marketed predicate device (Trojan Brand Latex Condoms) and ensuring the device operates as intended and defined in its description. The "reported device performance" refers to the results of the non-clinical tests conducted.

Study Information (Based on 510(k) Submission)

Given that this is a 510(k) premarket notification for a Class II medical device, the "study" described is a set of non-clinical tests aimed at demonstrating substantial equivalence rather than a traditional clinical trial following AI/diagnostic device protocols.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document** does not specify a discrete "test set" sample size** for biocompatibility, tensile strength/elongation, or virus testing. These tests are generally performed on a representative sample of manufactured devices (e.g., specific lots).
- Data provenance is not explicitly stated beyond the fact that Glyde USA, Inc. performed the testing. It is implied these are prospective tests conducted on their manufactured product.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests (like material properties or virus barrier) is established by standardized laboratory methods and scientific principles, not by expert human consensus in the way clinical diagnostic ground truth is established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are relevant for clinical studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies in findings. The tests described are laboratory-based.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This question is not applicable. An MRMC comparative effectiveness study is used for diagnostic devices, particularly AI-driven ones, to assess the impact of the device on human reader performance. Glyde Dam Lollyes is a barrier device, not a diagnostic tool, and has no AI component or human "reading" aspect.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. Glyde Dam Lollyes is not an algorithm or AI-driven device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests relied upon were:
  - Standardized material specifications (e.g., ASTM 1076-88 for latex).
  - Laboratory test methods for physical properties (tensile strength, elongation, dimensions, thickness).
  - Virological testing protocols to assess barrier efficacy against viruses.
  - Visual inspection criteria for manufacturing defects.
The sample size for the training set
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established
- This question is not applicable as there is no training set.

Summary

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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™

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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

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

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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

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510(k) Number

K970977

Device Name

Glyde Dam Lollyes

Indications for Use

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

Regulation Number and Section

§ 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.