(312 days)
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No
The device is a patient examination glove, and the description and testing focus on material properties and biocompatibility, with no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
A patient examination glove is intended to prevent contamination between patient and examiner. It does not diagnose any condition or disease.
No
The device description clearly states it is a "Powder Free Nitrile Patient Examination Glove," which is a physical hardware device. The testing and performance studies also focus on the physical properties and biocompatibility of the glove.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside of the body).
- Device Description: The description is of a physical glove, not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies focus on the physical properties of the glove (per ASTM standards) and biocompatibility (skin sensitization and irritation), which are relevant for a medical device worn on the body, not for an IVD.
In summary, the device is a medical device used for barrier protection during patient examination, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
80 LZA
Device Description
Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim, meets all of the requirements of ASTM D 6319-10.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
The study was conducted in two stages. In the first stage, a population of 50 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum of 200 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability.
The study completed on 200 non-sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical and clinical performance data.
Sample Size: 50 human subjects (first stage), total minimum 200 human subjects (second stage).
Key Results:
- Non-clinical testing: The gloves meet standard requirements referenced in Section 8.0 including dimensions, physical properties, freedom from pin-holes, powder free residue, and biocompatibility. Biocompatibility test indicates the gloves are not a contact skin sensitizer and not a primary skin irritant.
- Clinical performance (Modified Draize-95 Test): The study on 200 non-sensitized adult human subjects gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce Type IV allergy in the un-sensitized general user population in the tested article.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not a contact skin sensitizer
Not a primary skin irritant
No clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subjects.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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