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

LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color) is a disposable patient examination glove which is worn on the hand of a healthcare and similar personnel to prevent contamination between patient and examiner.

Device Description

LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for medical gloves. It does not contain any information about a study that proves a device meets acceptance criteria in the way you've described for AI/medical imaging devices.

The document is a regulatory approval for "LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free-Blue Color)", establishing its substantial equivalence to legally marketed predicate devices. This type of regulatory submission for Class I medical devices like examination gloves primarily focuses on:

Manufacturing standards: Ensuring the gloves are produced under good manufacturing practices.
Material safety: Demonstrating the materials used are safe for patient contact.
Performance specifications: Meeting established physical properties for gloves (e.g., tensile strength, puncture resistance, freedom from holes).

The details you've requested (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are typical for the evaluation of diagnostic devices, especially those utilizing AI or complex algorithms for image analysis or disease detection.

Therefore, I cannot provide the requested information based on the provided text because it is not relevant to the type of device and regulatory submission discussed.

To reiterate, this document is a letter from the FDA granting clearance for a physical medical device (examination gloves), not a report on a clinical or performance study involving complex data analysis or AI.

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K Number

K014134

Device Name

POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)

Manufacturer

SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD.

Date Cleared

2002-01-22

(36 days)

Product Code