DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS

• K Number: K992128
• Device Name: DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
• Manufacturer: DASH MEDICAL GLOVES SDN BHD
• Date Cleared: 1999-09-14 ( 83 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less); VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less)" and "VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves."

This document does not contain any information about acceptance criteria or a study proving device performance. It is an FDA clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device. The letter discusses regulatory classifications, general controls, and compliance requirements, but not specific performance metrics or study results.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

Regulation Number and Section

§ 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.