(78 days)
Not Found
Not Found
No
The device is a simple patient examination glove, and the description and performance data relate to physical properties and watertightness, with no mention of AI or ML.
No
The device is a patient examination glove used to prevent contamination, not to treat or alleviate a medical condition.
No
The device, a patient examination glove, is intended for preventing contamination and does not perform any diagnostic function. Its performance metrics relate to physical properties and barrier integrity, not the detection or diagnosis of medical conditions.
No
The device is a physical patient examination glove, not a software application. The description and performance studies focus on the physical properties of the glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hands 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 the material (nitrile), class (Class 1), and physical properties (powder-free, meeting ASTM and FDA standards for gloves).
- Performance Studies and Key Metrics: The performance data and key metrics are all related to the physical integrity and properties of the glove (watertightness, dimensions, thickness, tensile strength, elongation, powder content). These are not diagnostic performance metrics like sensitivity, specificity, or AUC.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken 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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"3 and FDA Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
Key results summarised in a table including: Watertight (1000 ml), Length (mm), Palm width (mm), Thickness (mm) (Single Layer), Physical Properties (Before Aging: Tensile Strength (Mpa), Ultimate Elongation (%), After Aging: Tensile Strength (Mpa), Ultimate Elongation (%)), Powder Content.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Watertight (1000 ml): Pass Gl AQL=2.5%
Length (mm): 240 mm minimum for all sizes
Palm width (mm): XS:
§ 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
K-050528
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
MAY 1 9 2005
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | SPI GLOVES SDN. BHD. |
| 5, Persiaran Greentown 8, | ||
| Greentown Business Centre, | ||
| 30450 Ipoh, Perak, Malaysia | ||
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Ms. CHUN CHOOI FONG | |
| Date of Summary Prepared | February 24, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Powder Free Nitrile Examination Glove | |
| Common Name | Exam Glove |
4.0 Identification of the Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a43 and FDA requirements.
Nitrile Patient Examination Glove
Description of The Device 5.0
Classification Name
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"3 and FDA Water Leak Test.
The Intended Use of Glove 6.0
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
1
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
7. Summary of Performance Data:
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
| TEST | ASTM D6319-00aE3 | POWDER FREE NITRILE EXAM GLOVES |
|---|---|---|
| 1. Watertight (1000 ml) | G I | |
| AQL=2.5% | Pass Gl | |
| AQL=2.5% | ||
| 2. Length (mm) | ||
| Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm) | ||
| Size XS | - |