FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Patient Examination Glove is a disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves are STRICTLY NOT intended for surgical use or as a substitute for surgery puposes.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA document (K993793) is a 510(k) clearance letter for a "Pre-powdered latex patient examination glove". This document focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices, and outlines the general controls and regulations applicable to such devices.

The document does not contain information about:

Specific acceptance criteria for the device's performance.
Results of any study proving device performance against acceptance criteria.
Details about sample sizes, data provenance, expert qualifications, adjudication methods, or ground truth establishment.
Any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies, as this is a physical medical device (gloves), not an AI/software device.

Therefore, I cannot provide a response with the requested information based on the input document.

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K Number

K990228

Device Name

GUTHRIE PRIME POWDER-FREE

Manufacturer

GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD

Date Cleared

1999-02-19

(25 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Powder-free Patient Examination glove is a disposable device which is primarily Intended for modition between patient and patient and examiner's hand or finger to prevent Intended for modition between patient and examiner.

Device Description

Powder-Free Latex Examination Trade Name: Gloves with 50 Micrograms or Less of Total Water Extractable Protein Per Gram

AI/ML Overview

The provided text is a letter from the FDA regarding a Guthrie Prime Powder-Free Latex Examination Glove. This document is a 510(k) premarket notification and primarily focuses on the regulatory approval for this medical device, asserting its substantial equivalence to previously marketed devices.

Based on the content, this document does not contain the information needed to describe acceptance criteria and a study proving a device meets them in the context of the requested details (e.g., AI performance, expert ground truth, sample sizes for test/training sets, MRMC studies). The device mentioned is a physical product (latex gloves), not a software or AI-driven diagnostic device that would typically have such performance criteria.

Therefore, I cannot fulfill your request using the provided text. The document is about a regulatory approval for a physical medical device, not a performance study as described in your prompt.

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