(204 days)
Not Found
Not Found
No
The device description and performance metrics are focused on the physical properties and regulatory compliance of examination gloves, with no mention of AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device, a patient examination glove, is intended to prevent contamination, not to treat any medical condition.
No
The device is a patient examination glove, which is intended to prevent contamination. It does not diagnose any condition or disease.
No
The device description clearly states it is a physical product (gloves) and the performance studies and key metrics relate to physical properties and testing of the gloves, not software.
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 is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on physical properties and standards related to gloves (ASTM standards, water leak tests, powder amount, protein content, biocompatibility). These are characteristics of a physical barrier device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
- Performance Studies and Metrics: The performance studies and key metrics listed are all related to the physical integrity and safety of the glove as a barrier (dimensions, physical properties, freedom from pinholes, powder amount, protein content, biocompatibility). These are not metrics typically associated with diagnostic accuracy (sensitivity, specificity, AUC, etc., although some of these are listed, they are not relevant to the function of a glove).
In summary, this device is a medical device (specifically, a Class I patient examination glove), but its function is to provide a physical barrier, not to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
A powder-Free 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.
Product codes
LYY
Device Description
The Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
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
medical purposes / Not Found
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)
The Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile are summarized with following technological characteristics compared to ASTM or equivalent standards.
CHARACTERISTICS: Dimensions; STANDARDS: D 3578-01a2; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Physical Properties; STANDARDS: D 3578-01a2; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Freedom from Pinhole; STANDARDS: D 3578-01a2 FDA CFR 800.20; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Powder Amount; STANDARDS: D 3578-01a2 D 6124 - 05; DEVICE PERFORMANCE:
§ 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
Image /page/0/Picture/0 description: The image shows the letters BPG in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black, and the background is white. The letters are slightly distressed, with some small imperfections and rough edges.
Lot 1357 & 1358, Jln Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh
48000 Rawang, Selangor Darul Ehsan, Malaysia.
Tel: +03-6092 1042, +03-6092 1142 Fax: +03-6091 2820
E-mail: bpg@streamyx.com Website: www.bpgloves.com
Image /page/0/Picture/3 description: The image contains two logos. The first logo on the left has the text "nqa. ISO 9001 Registered" and the UKAS logo with the number 015. The second logo on the right has the text "nqa. ISO 14001 Registered" and the UKAS logo with the number 015.