PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate

• K Number: K190466
• Device Name: PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate
• Manufacturer: Shen Wei USA Inc.
• Date Cleared: 2019-09-26 ( 212 days)
• Product Code: LZA , LZC , QDO
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs and Fentanyl Citrate.

Device Description

Powder-Free Nittle Examination Glove with pH conting, Black-Gray and White-Black Colors, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

AI/ML Overview

This looks like a 510(k) clearance letter for medical gloves, and a table showing breakthrough times for chemotherapy drugs and fentanyl citrate. This document does not describe:

• Acceptance Criteria for a Device: This document lists breakthrough times for certain chemicals with different glove types, which are performance data points, not acceptance criteria for an AI/ML medical device. Acceptance criteria for an AI/ML device would typically involve metrics like sensitivity, specificity, AUC, F1-score, or accuracy targets.
• A Study Proving the Device Meets Acceptance Criteria for an AI Device: This document reports results of chemical permeation tests for gloves, not a study evaluating an AI algorithm's performance. There is no mention of AI, machine learning, algorithms, or any type of "model" in this text.

Therefore, because the provided text is about medical gloves and their chemical resistance, and not an AI/ML medical device, I cannot fulfill your request for information related to:

1. A table of acceptance criteria and reported device performance (for an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts for ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Please provide a document related to an AI/ML medical device's performance study and its acceptance criteria if you would like me to answer those specific questions.

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.