HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC

• K Number: K993621
• Device Name: HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
• Manufacturer: PAMITEX INDUSTRIES SDN BHD
• Date Cleared: 1999-12-29 ( 64 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

Pre-Powdered with USP Absorbable Dusting Powder Latex Examination Glove-Blue Color with Protein Labeling Claims 100mic grams or less)

AI/ML Overview

The provided text is related to a 510(k) premarket notification for "Powdered Latex Examination Gloves, With Protein Content Labeling Claim (100 Micrograms or Less)." This document is an FDA clearance letter and an "Indications for Use" statement. It does NOT contain information about acceptance criteria, efficacy studies, or performance data of an AI/ML powered device.

Therefore, I cannot provide the requested information from the given text.

The request asks for specific details about an AI/ML powered device's performance, such as:

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

None of this information is present in the provided FDA 510(k) clearance letter for latex examination gloves, which is a traditional medical device, not an AI/ML powered one.

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.