RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE

• K Number: K103661
• Device Name: RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
• Manufacturer: RUBBERCARE PROTECTION PRODUCTS SDN BHD
• Date Cleared: 2011-03-23 ( 97 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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder Free Nitrile Examination Glove, White (non-colored) or Blue (Colored)

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a "Powder Free Nitrile Examination Glove." This type of document does not contain the information requested in the prompt regarding acceptance criteria and a study proving a device meets them.

The 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily providing detailed performance studies with acceptance criteria in the manner described for more complex diagnostic or AI-based devices.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Confirming the device's substantial equivalence.
• Stating its regulation number, name, and product code.
• Listing general controls and other FDA regulations applicable to the device.
• Specifying the "Indications for Use" for the glove.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set details.
9. Ground truth establishment for training sets.

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.