(101 days)
Not Found
No
The 510(k) summary describes standard latex examination gloves and does not mention any AI or ML capabilities. The performance studies focus on physical properties and biocompatibility, not algorithmic performance.
No.
The device (patient examination gloves) is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is described as physical gloves, not software. The summary details physical properties and testing of the gloves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM-D3578-01aE2), which are relevant to their barrier function and safety for medical use.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, treatment, or prevention of disease.
- Performance Studies: The performance studies listed focus on the physical characteristics and safety of the gloves (dimension, strength, leak test, biocompatibility, protein levels), not on diagnostic accuracy or performance.
IVD devices are used to examine specimens taken from the human body to provide information for diagnostic purposes. This device is a physical barrier used during patient examination.
N/A
Intended Use / Indications for Use
This Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate, with Protein Labeling claims (50 Micrograms or less) 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.
Product codes
LYY
Device Description
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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: 125 pieces of each size of the gloves were tested using the FDA specified 1,000 ml water leak test. The results are within the ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL.
Biocompatibility: Passed the tests for examination gloves as per APPENDIX K.
Total Residual Powder Content & Presence of Cornstarch: Residual Powder Content (ASTM D 6124-00) ranged from 0.6 - 1.4 mg/glove with a mean of 1.1 mg/glove, meeting the FDA requirement of 2 mg/glove max. Presence of Cornstarch was negative, meeting the FDA requirement.
Residual Protein Level: Claimed level was
§ 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
K07/060
JUL 26 2007
APPENDIX L
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER-FREE LATEX EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
Submitted For : SGMP Courpany Limited, 181 Moo 6, Tambol Kampaenspetch, Rattaphum, Songkhla 90180, Thailand.
Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emerald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: Tuckerjan@aol.com
Equivalent Predicate Device: POWDER FREE (MULTICOLORED) LATEX EXAM GLOVES which was granted a 510(k) # K052016
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 LATEX EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
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-D3578-01aE2 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-D3578-01aE2 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.
1
: 上一篇:
Technological Characteristics of Device:
1. Dimension
| DIMENSION | ASTM D3578-01aE2 | SGMP |
|---|---|---|
| X-Small | 70 mm +/- 10 mm | 70 - 80 mm |
| Small | 80 mm +/- 10 mm | 80 - 85 mm |
| Medium | 95 mm +/- 10 mm | 90 - 97 mm |
| Large | 111 mm +/- 10 mm | 105 - 111 mm |
| Length | 230 mm minimum | |
| for all sizes | 241 mm | |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Palm | 0.08 mm min | 0.10 mm min |
2. Physical Properties (ASTM-D3578-00gE2 Standard Specification for Latex Exam Gloves) on Lot# 6171
| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-00aE2 | SGMP | ASTM-D3578-00aE2 | SGMP | |
| Before Aging | ||||
| X-Small | ||||
| Small | ||||
| Medium | ||||
| Large | Mpa | |||
| 18.0 | Mpa | |||
| 26.5 | ||||
| 23.7 | ||||
| 27.0 | ||||
| 28.5 | % | |||
| 650 | % | |||
| 875 | ||||
| 805 | ||||
| 830 | ||||
| 840 | ||||
| After Aging | ||||
| X-Small | ||||
| Small | ||||
| Medium | ||||
| Large | 14.0 | 23.0 | ||
| 24.5 | ||||
| 25.8 | ||||
| 25.5 | 500 | 750 | ||
| 800 | ||||
| 730 | ||||
| 830 |
2
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 # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|---------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| 6171 | X-Small | 125 | Yes | 1 |
| 6171 | Small | 125 | Yes | 2 |
| 6171 | Medium | 125 | No | 0 |
| 6171 | Large | 125 | Yes | 1 |
| AGED | | | | |
| 6171 | X-Small | 125 | No | 0 |
| 6171 | Small | 125 | Yes | 1 |
| 6171 | Medium | 125 | Yes | 1 |
| 6171 | Large | 125 | Yes | 2 |
The above figures are within the ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL.
Biocompatibility ব
The bio-compatibility test results are as per attached in APPENDIX K and show that the gloves passed the tests for examination gloves.
5. Total Residual Powder Content & Presence of Cornstarch
| TEST | FDA
REQUIREMENT | INTERNAL SGMP's |
|---------------------------------------------|--------------------|---------------------------------------------------|
| Residual Powder Content
(ASTM D 6124-00) | 2 mg/glove max | Ranger : 0.6 -1.4 mg/glove
Mean : 1.1 mg/glove |
| Presence of Cornstarch | Negative | Negative |
3
6. Residual Protein Level.
| TEST | FDA ALLOW ABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-99 |