(207 days)
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.
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.
This document describes the acceptance criteria and performance data for "Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (50 Micrograms or Less)" submitted by SGMP Company Limited.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3578-05 Standard / FDA Requirement) | Reported Device Performance (SGMP) |
|---|---|---|
| Dimension (Width) | 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 | |
| Dimension (Length) | 230 mm minimum (for all sizes) | 240 mm |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Thickness - Palm | 0.08 mm min | 0.10 mm min |
| Tensile Strength (Before Aging) | 18.0 Mpa | X-Small: 25.1 MpaSmall: 22.8 MpaMedium: 28.0 MpaLarge: 26.3 Mpa |
| Tensile Strength (After Aging) | 14.0 Mpa | X-Small: 24.5 MpaSmall: 23.5 MpaMedium: 26.0 MpaLarge: 25.2 Mpa |
| Ultimate Elongation (Before Aging) | 650 % | X-Small: 830 %Small: 870 %Medium: 850 %Large: 855 % |
| Ultimate Elongation (After Aging) | 500 % | X-Small: 790 %Small: 805 %Medium: 780 %Large: 770 % |
| Water Tight Test (AQL) | 2.5% AQL (ASTM D3578-05 requirements) | Un-aged (Batch #7023):X-Small: 0 leaked (0%)Small: 2 leaked (1.6%)Medium: 1 leaked (0.8%)Large: 1 leaked (0.8%)Aged (Batch #7023):X-Small: 2 leaked (1.6%)Small: 0 leaked (0%)Medium: 1 leaked (0.8%)Large: 0 leaked (0%)All reported values are ≤ 2.5% |
| Biocompatibility | Passed tests for examination gloves (as per APPENDIX K) | Passed |
| Residual Powder Content | 10 mg/glove max (ASTM D 6124-06) | Ranger: 0.8-1.7 mg/gloveMean: 1.4 mg/glove |
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level | < 50 µg/dm2 (ASTM D 5712-99) | < 50 µg/dm2 |
2. Sample Size for Test Set and Data Provenance
- Dimension, Physical Properties, Residual Powder Content, Presence of Cornstarch, Residual Protein Level: The sample sizes for these tests are not explicitly stated for individual characteristics beyond the Water Tight Test. Data is reported for Lot #7023.
- Water Tight Test: 125 pieces of each size (X-Small, Small, Medium, Large) were tested, both un-aged and aged. This totals 1000 gloves (125 gloves x 4 sizes x 2 aging conditions).
- Data Provenance: The document states "Internal SGMP'S" for the residual powder content, indicating the data was generated internally by the manufacturer. The country of origin of the manufacturer is Thailand (SGMP Company Limited, 181 Moo 6, Tambol Kampaengpetch, Rattaphum, Songkhla 90180, Thailand). The data appears to be prospective testing for regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical product (latex examination gloves), and its performance is evaluated against established physical, mechanical, and chemical standards (e.g., ASTM standards, FDA requirements) rather than subjective expert interpretation of data like medical images.
4. Adjudication Method for the Test Set
Not applicable. Performance is measured against objective standards, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or a device involving human interpretation of outputs. Therefore, an MRMC study is irrelevant.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies of the device (the examination gloves) against defined standards and criteria, without human-in-the-loop performance being a factor for its primary function.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance is based on established industry standards and regulatory requirements. Specifically:
- ASTM D3578-05 Standard Specification for Latex Examination Gloves for Medical Application for dimensions, physical properties (tensile strength, ultimate elongation), and water tight test AQL.
- FDA specified 1,000 ml water leak test procedure.
- ASTM D 6124-06 for Residual Powder Content.
- ASTM D 5712-99 for Residual Protein Level.
- General biocompatibility tests for examination gloves (details in Appendix K, not provided).
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI algorithms that require a "training set." The product is a manufactured good tested against specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is relevant for this device.
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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.
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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 minimumfor 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 | Mpa18.0 | 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 |
:
·
.
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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 | 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/gloveMean : 1.4 mg / glove |
| Presence of Cornstarch | Negative | Negative |
6. Residual Protein Level.
| Test | FDA Allow Able level | Claimed Level |
|---|---|---|
| ASTM D 5712-99 | < $50 μgdm2$ | < $50 μgdm2$ |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2008
SGMP Company, Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue de la D'emerald Sparks, Nevada 89434-9550
Re: K072406
Trade/Device Name: Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: March 11, 2008 Received: March 13, 2008
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 vour 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Suette Y. Mchain 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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INDICATION FOR USE STATEMENT
Applicant : SGMP Company Limited
510K NUMBER : K O7 2406
Device Name : Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flayour and with protein labeling claims (50 Micrograms or less)
Indication For Use :
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.
Prescription Use ................. (Part 21 CFR 801.Subpart D) AND / OR
Over-The-Counter .. 21 CFR 801 Subpart C
Concurrence of CDRH , Office of Device Evaluation (ODE)
Shila A. Murphy K
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072406
2
§ 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.