POWDERFREE BLUE NITRILE EXAMINATION GLOVES

• K Number: K980285
• Device Name: POWDERFREE BLUE NITRILE EXAMINATION GLOVES
• Manufacturer: BESGLOVE MEDICARE SDN. BHD.
• Date Cleared: 1998-03-13 ( 46 days)
• Product Code: LZA
• 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powderfree Blue Nitrile Examination Gloves

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powderfree Blue Nitrile Examination Gloves." This document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

Instead, it is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices. The letter primarily addresses:

• The FDA's review and determination of substantial equivalence.
• Regulatory classification (Class I).
• Applicability of general controls provisions of the Federal Food, Drug, and Cosmetic Act.
• Contact information for various FDA offices.
• The "Indications For Use" for the gloves.

Therefore, I cannot provide the information requested in the prompt based on the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
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.

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.