(207 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No.
The device is a medical glove intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is described as examination gloves, intended to prevent contamination between patient and examiner. There is no indication that it is used to diagnose any disease or condition.
No
The device is a physical medical device (examination gloves) and the summary describes physical properties and performance tests, not software functionality.
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 a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description aligns with a medical glove, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical properties of the glove (water tightness, powder content, protein level) and biocompatibility, which are relevant to a barrier device.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health. This device does not perform such tests.
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.
The Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and 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 (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-D3578-05 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. Results within ASTM D3578-05 requirements for latex exam gloves of 2.5% AQL.
Biocompatibility: The bio-compatibility test results show that the gloves passed the tests for examination gloves.
Residual Powder Content: Ranger : 0.8-1.7 mg/glove, Mean : 1.4 mg / glove, which is below the FDA requirement of 10 mg/glove max.
Presence of Cornstarch: Negative, meeting the FDA requirement.
Residual Protein 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
K 072406
APPENDIX L
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND WITH PROTEIN LABELING CLAIMS (50 MICROGRAMS OR LESS)
Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kampaengpetch, 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 LATEX EXAM GLOVES which was granted a 510(k) # K011371
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 Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (50 Micrograms or less)
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-D3578-05 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-D3578-05 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
Technological Characteristics of Device:
1. Dimension
.
| DIMENSION | ASTM D3578-05 | 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 | 240 mm | |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Palm | 0.08 mm min | 0.10 mm min |
2. Physical Properties (ASTM-D3578-05 Standard Specification for Latex Exam Gloves) on Lot# 7023
| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-05 | SGMP | ASTM-D3578-05 | SGMP | |
| Before Aging | Mpa | |||
| 18.0 | Mpa | |||
| % | ||||
| 650 | % | |||
| X-Small | 25.1 | 830 | ||
| Small | 22.8 | 870 | ||
| Medium | 28.0 | 850 | ||
| Large | 26.3 | 855 | ||
| After Aging | 14.0 | 500 | ||
| X-Small | 24.5 | 790 | ||
| Small | 23.5 | 805 | ||
| Medium | 26.0 | 780 | ||
| Large | 25.2 | 770 |
:
·
.
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 | ||||
| 7023 | X-Small | 125 | No | 0 |
| 7023 | Small | 125 | Yes | 2 |
| 7023 | Medium | 125 | Yes | 1 |
| 7023 | Large | 125 | Yes | 1 |
| AGED | ||||
| 7023 | X-Small | 125 | Yes | 2 |
| 7023 | Small | 125 | No | 0 |
| 7023 | Medium | 125 | Yes | 1 |
| 7023 | Large | 125 | No | 0 |
The above figures are within the ASTM D3578-05 requirements for latex exam gloves of 2.5% AQL.
4. Biocompatibility
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 6124-06) | 10 mg/glove max | Ranger : 0.8-1.7 mg/glove |
| Mean : 1.4 mg / glove | ||
| Presence of Cornstarch | Negative | Negative |
6. Residual Protein Level.
| Test | FDA Allow Able level | Claimed Level |
|---|---|---|
| ASTM D 5712-99 |