(16 days)
Not Found
Not Found
No
The device description and performance data relate to the physical properties and barrier function of a patient examination glove, with no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination. It does not treat or alleviate a disease or condition.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly states it is a physical glove made of nitrile, and the performance studies focus on physical properties like watertightness, dimensions, thickness, and tensile strength, 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 a "disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of Diagnostic Function: The description of the glove and its performance metrics (watertightness, dimensions, thickness, tensile strength, powder content, biocompatibility) relate to its physical properties and safety as a barrier. There is no mention of analyzing biological specimens or providing diagnostic information.
Therefore, based on the provided information, this patient examination glove is not an IVD.
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, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 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
examiner
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 include:
- Watertight (1000 ml): Pass GI at AQL=2.5%
- Length: Min 230mm for all sizes (XS, S, M, L, XL), with Powdered Nitrile Exam Gloves showing 240mm minimum for all sizes.
- Palm width: Varied by size, e.g.,
§ 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
MAR 1 8 2005
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymcr.com.my
| 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 25, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Powdered Nitrile Examination Glove | |
| Common Name | Exam Glove | |
| Classification Name | Nitrile Patient Examination Glove |
4.0 Identification of the Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.
Description of The Device 5.0
Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.
6.0 The Intended Use of Glove
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
Summary of Performance Data: 7.
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-01aE2
AQL=2.5% | POWDERED NITRILE EXAM
GLOVES
AQL=2.5% |
|--------------------------------------------|------------------------------|---------------------------------------------|
| 1. Watertight (1000 ml) | G I | Pass GI |
| 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 | - |