LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES

• K Number: K982114
• Device Name: LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES
• Manufacturer: M/S MIDLAND LATEX PRODUCTS LTD.
• Date Cleared: 1999-01-21 ( 219 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 medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

LOPRP, AVT, EXAM-PERFECT, GUARDIAN, MILLENIUM FUS S2 & HEALTH TEC - Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less)

AI/ML Overview

The provided text is a set of FDA letters concerning a 510(k) premarket notification for latex examination gloves. It does not describe any acceptance criteria, device performance, or study details (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size or ground truth establishment) as requested in the prompt.

Therefore, I cannot provide the requested information from the given text.

The text primarily focuses on:

• Confirmation of the device being substantially equivalent to legally marketed predicate devices.
• Instructions regarding general controls provisions, potential additional controls, and compliance with regulations.
• The indications for use of the gloves ("A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.").
• Product names (LOPRO, AVT Exam-Perfect, Guardian, Millenium Fusion S2 & Health Tec Powder-Free Latex Examination Glove) and classification as over-the-counter.

No performance data or study methodology is present in these documents.

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.