(79 days)
The Innolatex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled or contoured with a reservoir tip; nominal length 180mm, nominal width 52mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is colored and flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
The provided text describes a 510(k) premarket notification for a Male Latex Condom and does not contain information about acceptance criteria, device performance, or a study proving it meets acceptance criteria for an AI/ML medical device. This document is related to a physical medical device (condom) and discusses its characteristics and intended use, comparing it to predicate devices.
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§ 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.