(58 days)
Not Found
Not Found
No
The device description and performance data relate to the physical properties and barrier function of a medical glove, with no mention of AI or ML.
No
This device, a medical glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is a medical glove, which is used to prevent contamination, not to diagnose a condition.
No
The device description clearly states it is a physical medical glove made of nitrile, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between healthcare personnel and patients/their environment. This is a barrier function, not a diagnostic function.
- Device Description: The description details the material, class, and standards it meets (ASTM D3578-95 and FDA Water Leak Test). These are related to the physical properties and barrier integrity of the glove, not to analyzing samples from the body.
- Performance Studies and Key Metrics: The performance data focuses on physical properties like watertightness, length, width, thickness, tensile strength, elongation, and powder content. These are all measures of the glove's physical performance and barrier effectiveness, not diagnostic accuracy or analytical performance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This glove does not perform any of these functions.
N/A
Intended Use / Indications for Use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
Product codes
LZA
Device Description
Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
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
healthcare 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)
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
Key results include:
- Watertight (1000 ml): GI AQL=4.0%, Pass GI AQL=4.0%
- Length (mm): Min 230 for all sizes (XS, S, M, L, XL), 240 mm minimum for all sizes
- Palm width (mm): 75 - 78 for XS, 82 - 88 for S, 92 - 98 for M, 102 - 108 for L, 111 - 115 for XL
- Thickness (mm) (Single Layer): Finger Min 0.08, 0.10 minimum; Palm Min 0.08, 0.10 minimum
- Physical Properties Before Aging: Tensile Strength (Mpa) Min 14, 30.4; Ultimate Elongation (%) Min 500, 640
- Physical Properties After Aging: Tensile Strength (Mpa) Min 14, 30.9; Ultimate Elongation (%) Min 500, 610
- Powder Content:
§ 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
NOV 1 7 1999
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
Attachment H
SMDA 510 (K) SUMMARY
| 2.0 | Submitter | SEAL POLYMER INDUSTRIES SDN BHD
Lot 72706, Jalan Lahat
Kawasan Perindustrian Bukit Merah
31500 Lahat, Perak, Malaysia |
|-----|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | Tel | (60 5) 322 3200 |
| | Fax | (60 5) 322 2300 |
| | Name of Contact Person | Mr. CHAN CHIN HONG |
| | Date of Summary Prepared | September 4, 1999 |
| 3.0 | Name of Device | |
| | Trade Name | Cashmere Non-Sterile, Powdered Nitrile
Examination Gloves (Blue)
Cashmere Non-Sterile, Powdered Nitrile
Examination Gloves (Green) |
| | Common Name | Exam Glove |
| | Classification Name | Patient Examination Glove |
4.0 Identification of The Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.
5.0 Description of The Device
1.0
Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
6.0 The Intended Use of Glove
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
1
SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
Attachment H
7. Summary of Performance Data :
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-95 | CASHMERE POWDERED NITRILE EXAM GLOVES | |
|---|---|---|---|
| 1. | Watertight (1000 ml) | GI AQL=4.0% | Pass GI AQL=4.0% |
| 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 | - | 75 - 78 | |
| S | 80 +/- 10 | 82 - 88 | |
| M | 95 +/- 10 | 92 - 98 | |
| L | 111 +/- 10 | 102 - 108 | |
| XL | - | 111 - 115 | |
| 4. | Thickness (mm) | ||
| (Single Layer) | |||
| Finger | Min 0.08 | 0.10 minimum | |
| Palm | Min 0.08 | 0.10 minimum | |
| 5. | Physical Properties |
Before Aging
Tensile Strength (Mpa) | Min 14 | 30.4 |
| | Ultimate Elongation (%) | Min 500 | 640 |
| | After Aging
Tensile Strength (Mpa) | Min 14 | 30.9 |
| | Ultimate Elongation (%) | Min 500 | 610 |
| 6. | Powder Content |