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K Number
K994312
Device Name
MALE LATEX CONDOM 56MM
Manufacturer
PLEASURE LATEX PRODUCTS SDN. BHD.
Date Cleared
2000-03-21

(90 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 varticular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Description

Male Natural Rubber Latex Condom [No particular brand name]

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a Male Latex Condom and does not contain the detailed information required to answer your request regarding acceptance criteria and study particulars for a medical device's performance.

Specifically, the document:

  • Approves the device as substantially equivalent to a predicate device.
  • Mentions regulatory class, applicable CFR sections, and general controls.
  • Discusses labeling requirements for latex condoms, including expiration dating and real-time test data.
  • States the Indications For Use.

However, it does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any specific test set.
  3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
  4. The type of ground truth used, training set sample size, or how ground truth was established for a training set.

This type of information is typically found in the 510(k) submission itself (which often includes summary data and test reports), not in the FDA's clearance letter. The clearance letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent.

§ 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.