(34 days)
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No
The device description and performance studies focus on the physical properties and barrier function of a standard medical glove, with no mention of AI or ML.
No
The device is a medical glove intended for contamination prevention, not for therapy or treatment.
No
The document describes a medical glove, which is intended for preventing contamination and is not used for diagnosis.
No
The device is a physical medical glove made of latex, not a software application. The description focuses on material properties and performance tests related to a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hand to prevent contamination between healthcare personnel and the patient. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The device is described as a "Class I latex patient examination glove." This classification and description align with a physical barrier device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological specimens, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical properties (water tightness, residual powder, protein levels) and biocompatibility, which are relevant to a barrier device, not an IVD.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class I latex patient examination glove, 80LYY, powder free And meeting all the requirements of ASTM D-3578-01aE2, Standard Specification for Latex Examination Gloves for Medical Application.
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
hand
Indicated Patient Age Range
Not Found
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)
1. Dimension
The device dimensions (X-Small, Small, Medium, Large, Length, Thickness - Finger, Thickness - Palm) were measured and compared against ASTM D3578-01aE2 standards. The SGMP measurements fell within or met the specified ranges.
2. Physical Properties
Tensile Strength and Ultimate Elongation were measured before and after aging for various sizes (X-Small, Small, Medium, Large). The results for SGMP gloves met or exceeded the requirements of ASTM-D3578-01aE2.
3. Water Tight Test
125 pieces of each glove size (X-Small, Small, Medium, Large) were tested for leaks using the FDA specified 1,000 ml water leak test, both un-aged and aged.
- Un-aged: X-Small (1 leak), Small (0 leaks), Medium (1 leak), Large (0 leaks).
- Aged: X-Small (1 leak), Small (0 leaks), Medium (1 leak), Large (1 leak).
The results are within the ASTM D3578-01aE2 requirements for latex exam gloves of 2.5% AQL.
4. Biocompatibility
The biocompatibility test results, as per APPENDIX L (not provided in the excerpt), show that the gloves passed the tests for examination gloves.
5. Total Residual Powder Content & Presence of Cornstarch
- Residual Powder Content (ASTM D 6124-01): The range was 0.5-0.9mg/glove with a mean of 0.7 mg/glove, meeting the FDA internal requirement of 2 mg/glove maximum.
- Presence of Cornstarch: Negative, meeting the FDA internal requirement.
6. Residual Protein Level
The protein level was tested using ASTM D 5712-99 and found to be
§ 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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