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K Number
K040108
Device Name
OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
Manufacturer
EST INTERNATIONAL CORPORATION
Date Cleared
2004-08-17

(210 days)

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

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR GINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Description

OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN (YELLOW GOLD)

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device: "Opus-E Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal and Lanolin (Yellow Gold)".

The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions. It does not contain information about:

  1. Acceptance criteria and reported device performance: This document is a regulatory approval, not a performance study report.
  2. Sample size and data provenance: No study data is presented.
  3. Number and qualifications of experts for ground truth: No ground truth establishment is discussed for a study.
  4. Adjudication method: Not applicable as no study is detailed.
  5. MRMC comparative effectiveness study: No such study is mentioned.
  6. Standalone performance study: No such study is mentioned.
  7. Type of ground truth used: Not applicable.
  8. Sample size for training set: Not applicable.
  9. How ground truth for training set was established: Not applicable.

The document is a clearance letter, indicating regulatory approval based on substantial equivalence, not a detailed report of a performance study with acceptance criteria.

§ 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.