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K Number
K013795
Device Name
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR
Manufacturer
SHEN WEI (USA), INC.
Date Cleared
2002-01-22

(69 days)

Product Code
LYY
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 disposable device intended for medical purpose that is worn on the examiner's a disposable do not internation belween patient and examiner. Tested for Use with Chemotherapy Drugs.

Device Description

Powder-Free Latex Examination Gloves with Aloe-and Protein Claim, Tested for Powderfriee Latex Cammation Color Color Color Color Color Color on or less on water Extractable Profess per gram

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) substantial equivalence determination letter from the FDA for "Powder-Free Latex Examination Gloves Green, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Tested For Use with Chemotherapy Drugs."

This type of letter primarily indicates that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It refers to general controls and regulations but does not detail specific performance acceptance criteria or study results in the way that would typically be found in a study report or clinical trial summary.

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.