(28 days)
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No
The document describes standard medical examination gloves and their performance testing against established standards. There is no mention of AI or ML capabilities.
No.
The device, a medical glove, is intended to prevent contamination between healthcare personnel and the patient, not to treat or mitigate a disease or condition in a patient.
No
Explanation: The document describes a medical glove, which is a barrier device used for contamination prevention. Its intended use and performance studies focus on physical properties, leak testing, and biocompatibility, none of which involve diagnosing a disease or condition.
No
The device description and performance studies clearly indicate a physical medical glove, not a software-only device. The studies focus on physical properties, water tightness, and biocompatibility of the glove material.
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 the patient. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details a medical glove meeting specifications for latex examination gloves. This aligns with a barrier device, not a diagnostic one.
- Performance Studies: The performance studies focus on physical properties, water tightness, biocompatibility, and residual content – all relevant to the safety and integrity of a barrier glove, not to the accuracy of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
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 patient.
Product codes
LYY
Device Description
Device is powder free patient examination gloves and meeting all the requirements Class II/Class I of ASTM D 3578-00 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
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Anatomical Site
hand
Indicated Patient Age Range
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
SEP 2 1 2001
APPENDIX M
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE CHOCOLATE SCENTED LATEX EXAMINATION GLOVES
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:
Device Name -- NON-STERILE POWDER FREE CHOCOLATE SCENTED LATEX EXAM GLOVES
Common Name - Exam gloves
Classification Name - Patient examination glove (per 21 CFR 880.6250)
Classification Information - Class I latex patient examination glove 80L YY, powder free and Classineation information - States 78-00 Standard Specification for Latex Examination Gloves for Medical Application.
Device Description:
Device beser patient examination gloves 80LYY, powder free and meeting all the requirements Class Plater parts of Specification for Latex Examination Gloves for Medical Application.
Intended Use of Device:
Intended Ose of Derice. contamination between health care personnel and patient.
Technological Characteristics of Device:
1. Dimension
| DIMENSION | ASTM D3578-00 | SGMP |
|---|---|---|
| X-Small | ||
| Small | ||
| Medium | ||
| Large | 70 mm +/- 10 mm | |
| 80 mm +/- 10mm | ||
| 95 mm +/- 10mm | ||
| 111 mm +/- 10 mm | 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
| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP | |
| Mpa | Mpa | % | % | |
| Before Aging | 14.0 | 700 | ||
| X-Small | 27.5 | 850 | ||
| Small | 24.3 | 810 | ||
| Medium | 24.5 | 810 | ||
| Large | 24.7 | 810 | ||
| After Aging | 14.0 | 500 | ||
| X-Small | 29.5 | 930 | ||
| Small | 19.5 | 790 | ||
| Medium | 23.6 | 820 | ||
| Large | 26.5 | 900 |
2. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1125
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 #
1125 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| | X-Small | 125 | No | 0 |
| | Small | 125 | Yes | 1 |
| | Medium | 125 | Yes | 2 |
| | Large | 125 | Yes | 1 |
| AGED | | | | |
| | X-Small | 125 | Yes | 1 |
| | Small | 125 | No | 0 |
| | Medium | 125 | Yes | 3 |
| | Large | 125 | No | 0 |
The above figures are within the draft FDA/ASTM D3578-00 requirements for latex exam gloves of 2.5% AQL.
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.
12800
| TESTS | FDA INTERNAL
REQUIREMENT | SGMP's |
|------------------------------------------------|-----------------------------|-----------------------------------------------|
| Residual Powder
Content
(ASTM D 6124-00) | 2 mg/glove max | Range: 0.8-1.6mg/glove
Mean : 1.2 mg/glove |
| Presence of Cornstarch | Negative | Negative |
5. Total Residual Powder Content & Presence of Cornstarch
6. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-99 |