(65 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device is described 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," which serves a barrier function rather than a therapeutic one.
No
The device is a glove, intended to prevent contamination between a patient and an examiner, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical properties and biocompatibility, not software functionality.
No, 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 examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for physical protection during examination.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D 5250-06e1).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies focus on physical properties, freedom from pinholes, powder residual, and biocompatibility – all relevant to a barrier device, not an IVD.
The information provided consistently describes a medical device used for physical protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 5250-06e1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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
Not Found
Summary of Performance Studies
Nonclinical testing was performed as summarized by the technological characteristics compared to ASTM or equivalent standard.
- Dimension: Meets ASTM standard D 5250-06 el.
- Physical Properties: Meets ASTM standard D 5250-06 el.
- Freedom from pinholes: Meets 21 CFR 800.20
- Powder Residual:
§ 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
Section C 510(k) Summary (21 CFR 807.92)
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510(K) 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: