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K Number
K193578
Device Name
Non-spermicidal Lubricated Male Latex Condom
Manufacturer
Global Protection Corp.
Date Cleared
2020-08-20

(241 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

Non-spermicidal Lubricated Male Latex Condoms are intended to prevent pregnancy, HIV/AIDS and other sexually transmitted infections.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a Non-spermicidal Lubricated Male Latex Condom. This type of device is subject to performance standards and does not typically involve the kind of AI-driven performance criteria, ground truth studies, or human-in-the-loop assessments described in your request. Your request is tailored for an AI/ML medical device, which this product is not.

Therefore, I cannot extract the information you requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-specific performance metrics from this document because it is not relevant to a condom.

The document primarily focuses on:

  • The device being substantially equivalent to a legally marketed predicate device.
  • Compliance with general controls provisions of the Act (e.g., registration, labeling, good manufacturing practices).
  • Indications for Use (preventing pregnancy, HIV/AIDS, and other STIs).
  • Classification as an Over-The-Counter device.

To provide the information you're looking for, I would need a document related to an AI/ML-based medical device.

§ 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.