(62 days)
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No
The summary describes a standard medical glove and its performance testing against established standards, with no mention of AI or ML technology.
No
Explanation: This device is a medical glove intended to prevent contamination between healthcare personnel and patients, not to treat or cure a disease or condition. It acts as a barrier, not a therapeutic agent.
No
Explanation: The device is a medical glove, which is used to prevent contamination, not to diagnose a condition.
No
The device is a physical medical glove, not a software-only device. The description clearly outlines its material (latex), physical properties, and performance testing related to its physical function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a medical glove, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties and barrier integrity of the glove (water tightness, tensile strength, etc.), not on diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.
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 patient.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Water Tight Test: Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested. Results for UN-AGED: X-Small (1 leaker), Small (0 leakers), Medium (1 leaker), Large (2 leakers). Results for AGED: X-Small (0 leakers), Small (1 leaker), Medium (2 leakers), Large (0 leakers). The figures are within the gloves of 2.5% AQL.
Biocompatibility: The bio-compatibility test results show that the gloves passed the tests for examination gloves.
Total Residual Powder Content & Presence of Cornstarch: Residual Powder Content (ASTM D 6124-00) for SGMP's Range: 0.5-0.8mg/glove, Mean : 0.63 mg/glove (FDA internal requirement 2 mg/glove max). Presence of Cornstarch: Negative (FDA internal requirement Negative).
Residual Protein Level: ASTM D 5712-95 Claimed Level:
§ 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
APPENDIX M
DEC 3 - 2001
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA & VITAMIN E
Contact person : Cheah Chor Hee
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Device Information:
Trade Name - NON-STERILE POWDER FREE GREEN LATEX EXAM GLOVES WITH ALOE VERA & VITAMINE WITH PRODUCTION LABELING CLAIM (450 Micros
Common Name - Exam gloves
Classification Name - Patient examination glove (per 21 CFR 880.6250) Classification Information - Class I latex patient examination glove 80LYY, powder free and
meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.
Device Description:
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.
Intended Use of Device:
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.
Technological Characteristics of Device:
| DIMENSION | ASTM D3578-00 | SGMP |
|---|---|---|
| X-Small | ||
| Small | ||
| Medium | ||
| Large | 70 mm +/- 10 mm | |
| 80 mm +/- 10mm | ||
| 95 mm +/- 10mm | ||
| 111mm +/- 10mm | 70 - 75 mm | |
| 80 - 85 mm | ||
| 90 - 97 mm | ||
| 105 - 111 mm | ||
| Length | 230 mm minimum | |
| for all sizes | 252mm | |
| Thickness - | ||
| Finger | ||
| Palm | 0.08mm min | |
| 0.08mm min | 0.08 mm min | |
| 0.08 mm min |
1. Dimension
1
| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP | |
| Before Aging | ||||
| X-Small | ||||
| Small | ||||
| Medium | ||||
| Large | Mpa | |||
| 14.0 | Mpa | |||
| 25.8 | ||||
| 27.8 | ||||
| 27.9 | ||||
| 27.1 | % | |||
| 700 | % | |||
| 830 | ||||
| 920 | ||||
| 900 | ||||
| 950 | ||||
| After Aging | ||||
| X-Small | ||||
| Small | ||||
| Medium | ||||
| Large | 14.0 | 24.1 | ||
| 27.0 | ||||
| 28.7 | ||||
| 25.6 | 500 | 950 | ||
| 910 | ||||
| 910 | ||||
| 910 |
2. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1186
3. Water Tight Test
Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested and our results are as given below:
| BATCH #
1186 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | X-Small | 125 | Yes | 1 |
| | Small | 125 | No | 0 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | Yes | 2 |
| AGED | X-Small | 125 | No | 0 |
| | Small | 125 | Yes | 1 |
| | Medium | 125 | Yes | 2 |
| | Large | 125 | No | 0 |
The above figures are within the gloves of 2.5% AQL.
FDA/ASTM D3578-00 requirements for latex exam
2
Biocompatibility 4.
The bio-compatibility test results are as per attached in APPENDIX L and show that the gloves passed the tests for examination gloves.
5. Total Residual Powder Content & Presence of Cornstarch
| TESTS | FDA INTERNAL
REQUIREMENT | SGMP's |
|------------------------------------------------|-----------------------------|------------------------------------------------|
| Residual Powder
Content
(ASTM D 6124-00) | 2 mg/glove max | Range: 0.5-0.8mg/glove
Mean : 0.63 mg/glove |
| Presence of Cornstarch | Negative | Negative |
6. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-95 |