(15 days)
Not Found
No
The device description and intended use clearly define a physical examination glove, with no mention of software, data processing, or AI/ML terms.
No
The device is a patient examination glove primarily used for preventing contamination, not for treating a disease or condition.
No
The device is a glove intended to prevent contamination, not to diagnose a medical condition.
No
The device described is a physical medical device (gloves) and does not involve any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of this device is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device used for protection, not for analyzing biological specimens.
- Lack of IVD Characteristics: The description and performance studies focus on the physical properties of the glove (meeting ASTM standards, biocompatibility) and its function as a barrier. There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
Therefore, based on the provided information, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Powder free vinyl patient examination glove, Clear (non-colored) 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.
Product codes
LYZ
Device Description
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 testing per ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO10993-10 to evaluate: Dimension, Physical Properties, Freedom from pinholes, Powder Residual, and Biocompatibility (Primary Skin Irritation in rabbits, Dermal sensitization in guinea pig). Results indicate the device meets requirements for these standards. Clinical data was not needed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: /