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K Number
K051913
Device Name
POWDERED LATEX PATIENT EXAMINATION GLOVES
Manufacturer
SHINEMOUND ENTERPRISE, INC.
Date Cleared
2005-09-30

(77 days)

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

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Device Description

Powdered Latex Patient Examination Gloves

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for "POWDERED LATEX PATIENT EXAMINATION GLOVES." It outlines the regulatory status and general controls for the device but does not contain the type of AI/ML device performance study details requested.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the document does not relate to an AI/ML device and does not describe such a study.

The document states:

  • Device Name: POWDERED LATEX PATIENT EXAMINATION GLOVES
  • Regulation Name: Patient Examination Glove
  • Regulatory Class: I
  • Product Code: LYY
  • Indications for Use: "A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)"

This is a traditional medical device (gloves), not an AI/ML diagnostic or prognostic tool, and therefore the concepts of "acceptance criteria" based on AI performance metrics, test/training sets, ground truth establishment, or MRMC studies do not apply to this specific FDA submission.

§ 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.