CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))

• K Number: K201067
• Device Name: CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))
• Manufacturer: CUPID Limited
• Date Cleared: 2020-08-07 ( 107 days)
• Product Code: HIS
• Regulation Number: 884.5300
• Type: Abbreviated
• Panel: OB
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

CUPID Brand Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for CUPID Brand Male Natural Rubber Latex Condoms. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as one would typically find for a novel diagnostic device or AI algorithm.

The 510(k) pathway for condoms relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the product performs similarly to existing, cleared products. For condoms, this typically involves demonstrating compliance with recognized standards for physical properties, rather than a clinical study with acceptance criteria in the way a diagnostic AI would have.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on regulatory clearance based on substantial equivalence.

If this were a document for a software as a medical device (SaMD) or an AI-powered diagnostic device, the requested information would be crucial for its clearance. However, for a condom, the regulatory requirements and supporting data are different.

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.