(34 days)
Not Found
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 description indicates it is a medical glove intended for preventing contamination, which is a protective rather than a therapeutic function.
No
Explanation: The device is described as a medical glove, intended to prevent contamination. Its performance studies focus on physical properties and biocompatibility, not on detecting, monitoring, or predicting diseases or health conditions.
No
The device is a physical medical glove, not a software-only device. The description focuses on material properties and physical performance tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a medical glove, which is a physical barrier.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical properties and integrity of the glove (tensile strength, water tightness, powder content, protein level), not on analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This medical glove does not perform such a function.
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
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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Dimension: Conforms to ASTM D3578-01aE2 standards for X-Small, Small, Medium, and Large sizes, and overall length and thickness.
- Physical Properties: Tested on Lot# 0320, showing tensile strength and ultimate elongation before and after aging, meeting or exceeding ASTM-D3578-01aE2 requirements.
- Water Tight Test: Using the FDA specified 1,000 ml water leak test, 125 pieces of each size were tested. Results showed a few leaks (1 or 0) for both un-aged and aged gloves, with figures within the ASTM D3578-01aE2 requirements for latex exam gloves of 2.5% AQL.
- Biocompatibility: Test results as per APPENDIX L show that the gloves passed the tests for examination gloves.
- Total Residual Powder Content & Presence of Cornstarch: Residual powder content ranged from 0.5-0.8mg/glove (mean 0.63 mg/glove), meeting the FDA internal requirement of 2 mg/glove max. Presence of Cornstarch was negative, meeting the FDA requirement.
- Residual Protein Level: Claimed level was
§ 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