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K Number
K102160
Device Name
STRETCH VINYL EXAMINATION GLOVE POWDER FREE
Manufacturer
SHANDONG BLUE SAIL INNOVATION CO., LTD.
Date Cleared
2010-10-04

(63 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 Stretch Vinyl Examination Glove Colored(Yellow/White) 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, Stretch Vinyl Examination Gloves, (Yellow/White)

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for Powder-Free, Stretch Vinyl Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance document rather than a study report. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information from the provided text. 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 performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This type of information is typically found in a separate study report or regulatory submission, not in the FDA's clearance letter itself.

§ 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.