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]).

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.

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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sheer Glyde Dams™:

The provided document is a 510(k) summary for the Sheer Glyde Dams, specifically relating to an addition to the indications for use (anilingus) rather than a de novo submission. As such, the information presented focuses on demonstrating substantial equivalence to the previously cleared device, not on proving initial effectiveness. Therefore, many standard study elements for proving device performance via clinical trials or extensive non-clinical testing for a new device are absent.

I will populate the table and answer your questions based only on the information available in the provided text. Many fields will be marked as "Not applicable" or "Not provided" because the document describes a change in indication for an already cleared device, not the initial approval of a new device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from document)	Reported Device Performance (from document)
Material Quality	Good quality rubber latex conforming to ASTM 1076-88	Manufactured from good quality rubber latex conforming to ASTM 1076-88
Physical Dimensions	10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (+ 0.0006 millimeters)	10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (+ 0.0006 millimeters)
Surface Integrity	Smooth surface (absence of cracks and blisters)	Visually tested for smooth surface
Defect Absence	Absence of holes, tears, foreign materials	Visually tested for holes, tears, foreign materials
Biocompatibility	Satisfactorily conclude biocompatibility	Qualification testing (biocompatibility) previously performed to satisfactorily conclude that Sheer Glyde Dams™ operate as intended.
Tensile Strength/Elongation	Satisfactorily conclude tensile strength/elongation	Qualification testing (tensile strength/elongation) previously performed to satisfactorily conclude that Sheer Glyde Dams™ operate as intended.
Virus Barrier	Satisfactorily conclude virus barrier effectiveness	Qualification testing (virus) previously performed to satisfactorily conclude that Sheer Glyde Dams™ operate as intended.
Intended Use	May help reduce the risk of catching or spreading many Sexually Transmitted Diseases (STDs) such as syphilis, gonorrhea, chlamydia infections, genital herpes, and AIDS.	The device's 'Intended Use' section states it may help reduce the risk of STDs when properly used. The 510(k) submission confirms "Testing is supportive of the new claim (i.e.: indication for use.)"

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not provided. The document states "Qualification testing (biocompatibility, tensile strength/elongation, and virus) was previously performed," implying these tests were done for the original 510(k) clearance, not specifically for this submission which adds an indication. No sample sizes are specified for any of these tests in this document.
- Data Provenance: Not provided. The document does not specify the country of origin of any test data. The tests were "previously performed" which implies they are retrospective relative to this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The document describes non-clinical performance and material testing, not a study involving expert-established ground truth for a diagnostic or screening device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This type of adjudication method is relevant for studies involving human interpretation or challenging cases, which is not described here.
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:
- No. An MRMC study was not done. The device is a physical barrier (latex dam), not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical product, not an algorithm. The "standalone" performance refers to the device's inherent physical and biological barrier properties, which were part of the "qualification testing" for biocompatibility, tensile strength/elongation, and virus testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and barrier properties, the "ground truth" would be established by standardized laboratory testing methods (e.g., ASTM standards for material properties, lab protocols for virus barrier testing).
- For the claim of reducing STD risk, the ground truth is based on the known barrier properties of latex, similar to condoms, where the intended use (as a barrier) is understood to reduce risk, rather than demonstrating 100% prevention through direct outcomes data for every STD.
The sample size for the training set:
- Not applicable/Not provided. There is no "training set" as this is not a machine learning or AI device.
How the ground truth for the training set was established:
- Not applicable/Not provided. No training set exists for this type of device.

Summary of the Document's Focus:

The provided 510(k) summary is for a change in the indications for use of an already cleared device. The core argument for substantial equivalence is that the product itself (Sheer Glyde Dams™) is identical to its predicate, and the new indication (anilingus) is simply an extension of its established barrier function, which was supported by previous "qualification testing" (biocompatibility, tensile strength/elongation, and viral barrier). The document explicitly states: "No additional testing is required as a result of the addition of the new indication for use. Testing is supportive of the new claim..." and "This new indication for use does not raise new issues of safety and effectiveness."

Summary

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2 19/99

K990067

APPENDIX E

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR SHEER GLYDE DAMS™

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K990067

Submitter

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™)

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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.

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

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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.

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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

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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]).

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)

Over-the Counter Use

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

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.