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K Number
K014087
Device Name
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2002-03-04

(83 days)

Product Code
LYY
Regulation Number
880.6250
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of the healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Device Description

Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove. This document does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.

The letter primarily:

  • Confirms the FDA's review of the 510(k) submission (K014087).
  • States that the device is substantially equivalent to legally marketed predicate devices.
  • Informs the manufacturer that they can market the device subject to general controls.
  • Outlines general regulatory compliance requirements.
  • Provides contact information for further guidance.
  • Includes a separate "Indications for Use" statement, which defines the intended purpose of the device.

Therefore, I cannot provide the requested information. The document does not describe:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. MRMC comparative effectiveness study results.
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used in a study.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This document is a regulatory clearance letter, not a performance study report.

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.