POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

• K Number: K984125
• Device Name: POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
• Manufacturer: KILANG BARANGAN GETAH DIOH
• Date Cleared: 1999-02-09 ( 83 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• 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

Powdered Latex Examination Gloves

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

The document is a US FDA 510(k) clearance letter for "Powdered Latex Examination Gloves," dated February 9, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

Here's what the document does include:

• Device Name: Powdered Latex Examination Gloves
• Regulatory Class: I
• Product Code: LYY
• Indications For 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."
• Applicant: Kilang Barangan Getah Dioh

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study, as it is not an AI-based device.
6. Information on a standalone algorithm performance.
7. Type of ground truth used (as it's not an AI device, this is not applicable in the way you're asking).
8. Sample size for the training set (not applicable for this type of device).
9. How the ground truth for the training set was established (not applicable for this type of device).

The 510(k) clearance process for this type of device (Class I examination gloves) primarily relies on demonstrating substantial equivalence to a predicate device, which often involves showing that the device meets recognized international or national standards for performance (e.g., ASTM standards for barrier integrity, dimensions, etc.) rather than clinical studies with expert ground truth or AI performance metrics.

To get the kind of information you are asking for, you would typically need a more detailed study report or a 510(k) summary for a more complex device, particularly one involving AI or diagnostic imaging.

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.