(101 days)
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.
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.
Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves
This report summarizes the acceptance criteria and device performance for the "POWDER-FREE LATEX EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)" developed by SGMP Company Limited. The information is extracted from the provided 510(k) summary (K07/060).
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the ASTM D3578-01aE2 and ASTM D3578-00aE2 standards for latex examination gloves, as well as FDA requirements for powder-free gloves and protein labeling.
| Acceptance Criteria Category | Specific Test / Requirement | Acceptance Criteria (Standard / FDA) | Reported Device Performance (SGMP) |
|---|---|---|---|
| Dimension | X-Small Width | 70 mm +/- 10 mm | 70 - 80 mm |
| Small Width | 80 mm +/- 10 mm | 80 - 85 mm | |
| Medium Width | 95 mm +/- 10 mm | 90 - 97 mm | |
| Large Width | 111 mm +/- 10 mm | 105 - 111 mm | |
| Length (all sizes) | 230 mm minimum | 241 mm | |
| Thickness - Finger | 0.08 mm min | 0.13 mm min | |
| Thickness - Palm | 0.08 mm min | 0.10 mm min | |
| Physical Properties (Before Aging) | Tensile Strength (Mpa) | 18.0 Mpa | X-Small: 26.5, Small: 23.7, Medium: 27.0, Large: 28.5 |
| Ultimate Elongation (%) | 650 % | X-Small: 875, Small: 805, Medium: 830, Large: 840 | |
| Physical Properties (After Aging) | Tensile Strength (Mpa) | 14.0 Mpa | X-Small: 23.0, Small: 24.5, Medium: 25.8, Large: 25.5 |
| Ultimate Elongation (%) | 500 % | X-Small: 750, Small: 800, Medium: 730, Large: 830 | |
| Water Tight Test (Pinhole) | AQL (Acceptable Quality Level) | 2.5% AQL (ASTM D3578-00aE2) | Less than 2.5% AQL (as shown by individual leak numbers per batch) |
| Biocompatibility | - | Passed tests for examination gloves (as per APPENDIX K) | Passed tests for examination gloves (as per APPENDIX K) |
| 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 |
| Residual Protein Level | ASTM D 5712-99 | < 50 µg/dm² | < 50 µg/dm² |
2. Sample Size Used for the Test Set and Data Provenance
- Dimension: Specific sample sizes are not explicitly stated, but the "SGMP" column provides data ranges or single values, implying testing was done.
- Physical Properties: For "Lot# 6171," the test results are reported for X-Small, Small, Medium, and Large sizes, both before and after aging. No specific number of gloves per size within Lot# 6171 is provided for these physical properties.
- Water Tight Test: 125 pieces of each glove size (X-Small, Small, Medium, Large) from "Batch # 6171" were tested, both un-aged and aged, for a total of 8 batches of 125 gloves (1000 individual gloves).
- Residual Powder Content & Presence of Cornstarch: The results are reported as a range and mean for residual powder, and a single "Negative" for cornstarch, indicating testing was performed, but specific sample size is not mentioned.
- Residual Protein Level: No specific sample size is given for this test.
Data Provenance: The data appears to be retrospective and gathered from internal testing conducted by SGMP Company Limited (Thailand), the manufacturer of the device. The data is presented as direct test results from their products, measured against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. For medical devices like examination gloves, the "ground truth" is typically defined by adherence to established industry standards (like ASTM) and regulatory requirements (like FDA's AQL for pinholes). These standards are developed through a consensus process involving experts in the field, but individual expert adjudication of specific test results for this 510(k) submission is not described. The manufacturer reports their own test results against these predefined standards.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies involving human interpretation or expert evaluation, often in medical imaging or diagnostic contexts, where there might be disagreement among initial assessors.
For this device (examination gloves), the "adjudication" is essentially the direct measurement and comparison of physical and chemical properties against objective, predefined industry and regulatory standards. There is no indication of human expert adjudication of individual test outcomes beyond the standard quality control and laboratory procedures to ensure accurate measurements. The reported values are direct measurements (e.g., tensile strength, length, number of leaks) that are then compared to the numerical thresholds set by the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices where human readers interpret medical data (e.g., radiologists interpreting images) and the AI's effect on their performance is evaluated. This submission is for medical examination gloves, which do not involve human interpretation of data in the same way, nor the use of AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone (algorithm-only) study was not done, as this product is not an AI/algorithm-driven device. The performance described is purely for the physical product itself, based on direct physical and chemical testing.
7. The Type of Ground Truth Used
The ground truth used for this study is primarily established industry standards and regulatory requirements. Specifically:
- ASTM D3578-01aE2 and ASTM D3578-00aE2 Standard Specifications for Latex Examination Gloves for Medical Application: These standards define the acceptable ranges and minimums for dimensions, tensile strength, ultimate elongation, and AQL for pinholes.
- FDA requirements: Such as the 1,000 ml water leak test for pinholes and the maximum limit for residual powder content (2 mg/glove).
- Other ASTM standards: ASTM D 6124-00 for residual powder content and ASTM D 5712-99 for residual protein level.
These standards serve as the objective benchmarks against which the device's performance is measured.
8. The Sample Size for the Training Set
This concept is not applicable. The device is a physical product (examination gloves), not an AI/machine learning model that requires a "training set." The information provided describes the testing of the manufactured product directly against established performance criteria.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable. As there is no AI/machine learning model, there is no "training set" or ground truth for such a set to be established. The ground truth for evaluating the physical product is defined by the existing ASTM and FDA standards.
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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.
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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 minimumfor 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 AgingX-SmallSmallMediumLarge | Mpa18.0 | Mpa26.523.727.028.5 | %650 | %875805830840 |
| After AgingX-SmallSmallMediumLarge | 14.0 | 23.024.525.825.5 | 500 | 750800730830 |
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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 | NUMBERLEAKED |
|---|---|---|---|---|
| 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 | FDAREQUIREMENT | INTERNAL SGMP's |
|---|---|---|
| Residual Powder Content(ASTM D 6124-00) | 2 mg/glove max | Ranger : 0.6 -1.4 mg/gloveMean : 1.1 mg/glove |
| Presence of Cornstarch | Negative | Negative |
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6. Residual Protein Level.
| TEST | FDA ALLOW ABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-99 | < 50 $\mu$ g/dm² | < 50 $\mu$ g/dm² |
Conclusion:-
The data presented indicate that the Non-sterile Powder Free Latex Examination Gloves, (Multicolored with Xylitol and Calcium Carbonate)
-
- meets/exceeds ASTM- D3578-00aE2 Standard Specifications For Latex Examination Glove,
-
- meets FDA pinhole requirements,
-
- meets FDA claim criterion of a powder free glove.
-
- meets the protein labeling claims level at <50 µg/ dm2
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2007
SGMP Company Limited C/O Janna P. Tucker President-Chief Executive Officer Tucker and Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K071060
Trade/Device Name: Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate), with Protein Labeling Claims (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 26, 2007 Received: June 29, 2007
Dear Ms. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Ms. Tucker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Snite Y. Michie Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
SGMP COMPANY LTD. APPLICANT:
510(k) NUMBER (if known):
510(k) NUMBER (if known): K071060
DEVICE NAME:
Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate), with Protein Labeling claims (50 Micrograms or less)
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.
Prescription Use ..... Per 21 CFR 801.109 AND/OR
Over-The-Counter Use ... A........ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J10(k) Number:
Shule R. Murphy ho
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Division Sign-Off)
Division of Anesthesiology, General Hospital
fection Control, Dental Devices
§ 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.