(28 days)
Not Found
Not Found
No
The device is a medical glove and the summary describes standard physical and biocompatibility testing, with no mention of AI or ML.
No
The device is a medical glove intended to prevent contamination between healthcare personnel and the patient, which is a barrier function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
No
Explanation: The device is described as a medical glove intended to prevent contamination, and its performance studies focus on physical properties, water tightness, and biocompatibility, not on diagnosing any condition.
No
The device is a physical medical glove made of latex, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description is for a "Class I latex patient examination glove." This is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on physical properties, water tightness, biocompatibility, and powder content, which are relevant to the function of a glove as a barrier.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but not an In Vitro Diagnostic device.
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
LYY
Device Description
Class I latex patient examination glove 80LZA, powder free Modical Archicetion, executively of ASTM Class I latex patient examination grove 80224, power 1100 million Application, except for the elongation at break parameter.
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
health care 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)
- Water Tight Test: Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested.
- UN-AGED:
- X-Small: Sample Size 125, Leaked 2 (Yes)
- Small: Sample Size 125, Leaked 0 (No)
- Medium: Sample Size 125, Leaked 1 (Yes)
- Large: Sample Size 125, Leaked 0 (No)
- AGED:
- X-Small: Sample Size 125, Leaked 1 (Yes)
- Small: Sample Size 125, Leaked 2 (Yes)
- Medium: Sample Size 125, Leaked 1 (Yes)
- Large: Sample Size 125, Leaked 0 (No)
- Result: The figures are within the gloves of 2.5% AQL.
- UN-AGED:
- Biocompatibility: Test results are as per attached in APPENDIX L and show that the gloves passed the tests for examination gloves.
- Total Residual Powder Content & Presence of Cornstarch:
- Residual Powder Content (ASTM D 6124-00): Range: 0.6-1.2g/glove, Mean: 0.9mg/glove (FDA requirement: 2 mg/glove max)
- Presence of Cornstarch: Negative (FDA requirement: Negative)
- Residual Protein Level: ASTM D 5712-95:
§ 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 K
K0128
9/21/01
510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR SUMMARY OF THE SALES I THE SALET I THE TIC EXAMINATION GLOVES
Contact person : Ong Lay Mau
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Device Information:
Device Information:
Trade Name - POWDER FREE GREEN COLOR SYNTHETIC EXAM GLOVES
Common Name - Exam gloves
Common Name - Patient examination glove (per 21 CFR 880.6250)
Classification Name - Patient examilation gover (per of or other 80LY ) remination Gloves for Medical Classification Information - Class I latex paned Cancification for Latex Examination Gloves for Medical the requirements of the elongation at break parameter.
Device Description:
Device Description:
Class I latex patient examination glove 80LZA, powder free Modical Archicetion, executively of ASTM Class I latex patient examination grove 80224, power 1100 million Application, except for the elongation at break parameter.
Intended Use of Device:
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:
1. Dimension
| DIMENSION | ASTM D3578-99 | Shield Gloves |
|---|---|---|
| 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 | 242mm | |
| 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 | |
| Before Aging | ||||
| X-Small | ||||
| Small | ||||
| Medium | ||||
| Large . | Mpa | |||
| 14.0 | Mpa | |||
| 25.3 | ||||
| 26.0 | ||||
| 28.9 | ||||
| 22.0 | % | |||
| 700 | % | |||
| 840 | ||||
| 850 | ||||
| 860 | ||||
| 840 | ||||
| After Aging | ||||
| X-Small | ||||
| Small | ||||
| Medium | ||||
| Large | 14.0 | 21.3 | ||
| 23.4 | ||||
| 23.6 | ||||
| 21.7 | 500 | 890 | ||
| 930 | ||||
| 940 | ||||
| 900 |
Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) 2. on Lot# 1128
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 #
1128 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | X-Small | 125 | Yes | 2 |
| | Small | 125 | No | 0 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | No | 0 |
| AGED | X-Small | 125 | Yes | 1 |
| | Small | 125 | Yes | 2 |
| | Medium | 125 | Yes | 1 |
| | 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: 0.6-1.2g/glove
Mean : 0.9mg/glove |
| Presence of Cornstarch | Negative | Negative |
Residual Protein Level 6.
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-95 |