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510(k) Data Aggregation
K Number
K990067Device Name
SHEER GLYDE DAMS
Manufacturer
LOUISE C. MYERS
Date Cleared
1999-02-19
(42 days)
Product Code
MSC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LOUISE C. MYERS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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