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K Number
K024338
Device Name
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE
Manufacturer
GENERAL GLOVES CORP.
Date Cleared
2003-03-03

(66 days)

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

A vinyl 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.

Device Description

POWDER-FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE

AI/ML Overview

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for "Powder-Free Vinyl Examination Gloves with Aloe Coating Inside."

The letter primarily focuses on:

  • Substantial Equivalence Determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
  • Regulatory Classification: Identifying the device as Class I and subject to general controls.
  • Compliance with Regulations: Reminding the manufacturer of their responsibility to comply with various FDA regulations (e.g., registration, listing, labeling, good manufacturing practices).
  • Indications for Use Statement: Defining the intended use of the glove.

There is no mention of:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
  • Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • Types of ground truth used.
  • Sample size for training sets or how ground truth for training was established.

This type of FDA clearance (510(k)) typically relies on demonstrating substantial equivalence to a predicate device, often through performance testing detailed in the submission, but the letter itself does not contain the specifics of those tests or their results.

§ 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.