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K Number
K024324
Device Name
LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
Manufacturer
GLOBAL PROTECTION CORP.
Date Cleared
2003-03-25

(89 days)

Product Code
HIS
Regulation Number
884.5300
Type
Abbreviated
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The (no particular brand name) condom, is intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, it can reduce the risk of pregnancy.

Device Description

Non-spermicidal Lubricated male Latex Condom

AI/ML Overview

The provided text is a scanned letter from the FDA regarding the 510(k) clearance for a "Non-spermicidal Lubricated male Latex Condom". It outlines the regulatory status and requirements for such devices.

However, the provided document does not contain any information about acceptance criteria for a device, nor does it describe any study (clinical or otherwise) that proves the device meets specific acceptance criteria.

The document primarily focuses on:

  • The FDA's decision of "substantial equivalence" for the device based on a 510(k) submission.
  • Regulatory requirements for marketing the device, including general controls, specific regulations like 21 CFR 801.435 for condom labeling and expiration dating, and Good Manufacturing Practice (GMP).
  • The "Indications for Use" statement for the condom.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study from this document. The prompt asks for details about a study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, none of which are present in these pages.

§ 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.