(54 days)
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Not Found
No
The device description and intended use clearly describe a standard medical glove, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device, a nitrile examination glove, is intended to prevent contamination between healthcare personnel and patients, not to treat a disease or condition.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose medical conditions.
No
The device description clearly states it is a physical glove, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient." This describes a barrier device used for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties and standards met by the glove, consistent with a medical device used for protection.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is a physical barrier.
N/A
Intended Use / Indications for Use
Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Gloves, Blue Color are intended for single use for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.
Powder Free Nitrile Examination Glove, Blue Color is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Product codes
LZA
Device Description
Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Gloves, Blue Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are blue in colour and are powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand
Indicated Patient Age Range
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Intended User / Care Setting
health care and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory and animal based test data indicate that the powder-free product meets all performance and biocompatability requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Testing performed per ASTM D 6319-00a Nitrile Examination Gloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application.
Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation of sensitization.
Final product is negative for the presence of starch using the USP iodine test.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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