(14 days)
Not Found
Not Found
No
The device is a standard patient examination glove and the summary focuses on material properties and performance against established standards, with no mention of AI or ML.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat or alleviate a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic, as it does not gather or analyze information to identify a medical condition.
No
The device description clearly states it is a physical glove made of nitrile, and the performance studies focus on physical properties and biocompatibility, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hands or finger. 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 standards, water leak test). These are characteristics of a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis.
- Performance Studies: The performance studies focus on physical properties like watertightness, dimensions, thickness, tensile strength, and biocompatibility. These are relevant to the function of a protective glove, not a diagnostic test.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device 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 D6319-00a53 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 / 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.
TEST: Watertight (1000 ml), ASTM D6319-00aE3, AQL=2.5%, Pass GI.
Length (mm): Min 230 for all sizes (XS, S, M, L, XL), Result: 240 mm minimum for all sizes.
Palm width (mm): Size 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
MAR 1 6 2305 SPI GLOVES SDN. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.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 23, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Polymer Coated Powder Free Nitrile Examination | |
| Gloves (Blue, White, Violet, Pink, Green) | ||
| Common Name | Exam Glove | |
| Classification Name | Nitrile Patient Examination Glove |
Identification of the Legally Marketed Devices 4.0
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.
5.0 Description of The Device
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that 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.
Page 1 of 3 ATTACHMENT Q
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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.
| | | POLYMER COATED POWDER
FREE NITRILE EXAM GLOVES | |
|-------------------------------------|------------------|---------------------------------------------------|----------|
| TEST | ASTM D6319-00aE3 | Pass GI | AQL=2.5% |
| 1. Watertight (1000 ml) | GI
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 | - |