Patient Examination Gloves

• K Number: K143419
• Device Name: Patient Examination Gloves
• Manufacturer: HARTALEGA NGC SDN. BHD.
• Date Cleared: 2015-03-06 ( 98 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant with Protein Labeling Claim of 50 Microgram or Less per Gram of Clove and Latex Powder Free Examination Gloves with Colloidal Oatheriz United Protectant with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove - Lemon Green is a non -- sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Not Found

AI/ML Overview

This document is a FDA 510(k) premarket notification letter for a medical device: "Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove."

The document does not contain the information requested in your prompt regarding acceptance criteria and study details for an AI-powered medical device. It pertains to a physical medical device (examination gloves) and its regulatory clearance process, not a software or AI device.

Therefore, I cannot extract the information to fill your table or answer your questions. The provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts, their qualifications, or ground truth establishment methods for test sets.
4. Adjudication methods.
5. Details of MRMC comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for training sets.
9. Methods for establishing ground truth for training data.

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.