Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim

• K Number: K220672
• Device Name: Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
• Manufacturer: Riverstone Resources Sdn Bhd
• Date Cleared: 2022-06-03 ( 88 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K192461 , K191986 , K172109

Intended Use

The intended use of the device is to aid in the detection of pulmonary nodules (2-30 mm in diameter) in adults (22 years of age and older) on chest radiographs. The device is intended to be used as a concurrent reader. The device is not intended to be used for diagnosis. The device is intended to be used in the radiology department.

Device Description

The device is a software device that uses artificial intelligence to analyze chest radiographs. The device is intended to be used as a concurrent reader to aid in the detection of pulmonary nodules. The device is not intended to be used for diagnosis. The device is intended to be used in the radiology department.

AI/ML Overview

Please provide the input text you are referring to as "{0}", "{1}", and "{2}". I need this information to describe the acceptance criteria and the study that proves the device meets them.

Once you provide the input, I will be able to construct a comprehensive response including:

1. A table comparing acceptance criteria with reported device performance.
2. Details on sample size, data provenance, and study design (retrospective/prospective).
3. Information on the number and qualifications of experts used for ground truth establishment.
4. Description of the adjudication method employed for the test set.
5. Whether an MRMC study was conducted and its findings regarding AI assistance.
6. Confirmation of standalone algorithm performance evaluation.
7. The type of ground truth utilized (e.g., expert consensus, pathology, outcomes).
8. The sample size of the training set.
9. The methodology for establishing ground truth within the training set.

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.