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K Number
K070937
Device Name
MULTIPLE BRAND MALE LATEX CONDOM
Manufacturer
NULATEX SDN. BHD.
Date Cleared
2007-09-21

(170 days)

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

This [MULTIPLE BRAND] latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for male natural rubber latex condoms. It indicates that the device has been found substantially equivalent to a legally marketed predicate device for contraception and prophylactic purposes.

The document discusses:

  • The trade name of the device and its classification.
  • The regulatory framework for medical devices.
  • The intended use of the condom.

It does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any study.
  3. Details about experts or ground truth establishment.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. The type of ground truth used.
  8. Training set sample sizes or ground truth establishment for a training set.

Therefore, I cannot answer your request based on the provided input.

§ 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.