(28 days)
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.
Device beser patient examination gloves 80LYY, powder free and meeting all the requirements Class Plater parts of Specification for Latex Examination Gloves for Medical Application.
This request is about a medical device, but the provided text describes a "NON-STERILE POWDER FREE CHOCOLATE SCENTED LATEX EXAM GLOVES". This type of product is a medical device, but it is not an AI/ML powered device, so acceptance criteria and study information mentioned in the request are not applicable.
However, since there are acceptance criteria and study data on device performance, I will provide the information accordingly.
Acceptance Criteria and Device Performance for Powder-Free Chocolate Scented Latex Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-00 / FDA Internal Requirement) | Reported Device Performance (SGMP) |
|---|---|---|
| Dimension - Width | ||
| X-Small | 70 mm +/- 10 mm | 70 - 75 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) | 252 mm |
| Thickness - Finger | 0.08 mm min | 0.08 mm min |
| Thickness - Palm | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Before Aging) | 14.0 Mpa | X-Small: 27.5 MpaSmall: 24.3 MpaMedium: 24.5 MpaLarge: 24.7 Mpa |
| Tensile Strength (After Aging) | 14.0 Mpa | X-Small: 29.5 MpaSmall: 19.5 MpaMedium: 23.6 MpaLarge: 26.5 Mpa |
| Ultimate Elongation (Before Aging) | 700 % | X-Small: 850 %Small: 810 %Medium: 810 %Large: 810 % |
| Ultimate Elongation (After Aging) | 500 % | X-Small: 930 %Small: 790 %Medium: 820 %Large: 900 % |
| Water Tight Test (AQL) | 2.5% AQL (draft FDA/ASTM D3578-00) | Un-aged: Overall 4 leaks out of 500 (0.8%)Aged: Overall 4 leaks out of 500 (0.8%) |
| Biocompatibility | Passed relevant tests for examination gloves | Passed tests for examination gloves |
| Residual Powder Content (ASTM D 6124-00) | 2 mg/glove max | Range: 0.8-1.6 mg/gloveMean: 1.2 mg/glove |
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level (ASTM D 5712-99) | < 50 µg/g | < 50 µg/g |
2. Sample Size Used for the Test Set and Data Provenance
- Dimension, Tensile Strength, Ultimate Elongation: The data lists performance per size (X-Small, Small, Medium, Large) in "SGMP" columns. It's implied that these are measurements taken on samples of the gloves, but the specific sample size for each dimension or mechanical property test is not explicitly stated beyond "Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1125".
- Water Tight Test: 125 pieces of each size (X-Small, Small, Medium, Large) were tested for both un-aged and aged conditions. This totals 1000 gloves tested (125 * 4 sizes * 2 conditions).
- Residual Powder Content, Presence of Cornstarch, Residual Protein Level: The data is reported as ranges or means for the product, implying sampling, but specific sample sizes are not explicitly provided.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it is retrospective or prospective. Given that it's a 510(k) submission from "SGMP Company Limited" with a contact person "Cheah Chor Hee," it is likely data collected by the manufacturer for the purpose of this submission (prospective data collection for regulatory approval).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a testing report for physical, chemical, and biological properties of a latex glove, not a performance study that requires expert judgment for ground truth establishment. The "ground truth" here is defined by objective measurement standards (e.g., ASTM standards, FDA requirements).
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this is a report of objective measurements against specified standards, not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret outputs, often with and without AI assistance. This document describes the performance of a physical product (gloves), not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to recognized national and international standards and regulatory requirements. These include:
- ASTM D3578-00 Standard Specification for Latex Examination Gloves for Medical Application: This standard defines the acceptable ranges for dimensions and mechanical properties (tensile strength, ultimate elongation).
- FDA specified 1,000 ml water leak test: Used for the water-tightness assessment.
- Draft FDA/ASTM D3578-00 requirements for latex exam gloves of 2.5% AQL: Used as the acceptance quality limit for the water leak test.
- Biocompatibility tests: Implied to be against recognized standards for medical devices, "passed the tests for examination gloves."
- ASTM D 6124-00: Standard for residual powder content.
- FDA Internal Requirement for Residual Powder Content: 2 mg/glove max.
- ASTM D 5712-99: Standard for residual protein level.
- FDA Allowable Level for Residual Protein Level: < 50 µg/g.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described in point 8, there is no training set for this type of device.
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SEP 2 1 2001
APPENDIX M
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE CHOCOLATE SCENTED LATEX EXAMINATION GLOVES
Contact person : Cheah Chor Hee
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Device Information:
Device Name -- NON-STERILE POWDER FREE CHOCOLATE SCENTED LATEX EXAM GLOVES
Common Name - Exam gloves
Classification Name - Patient examination glove (per 21 CFR 880.6250)
Classification Information - Class I latex patient examination glove 80L YY, powder free and Classineation information - States 78-00 Standard Specification for Latex Examination Gloves for Medical Application.
Device Description:
Device beser patient examination gloves 80LYY, powder free and meeting all the requirements Class Plater parts of Specification for Latex Examination Gloves for Medical Application.
Intended Use of Device:
Intended Ose of Derice. contamination between health care personnel and patient.
Technological Characteristics of Device:
1. Dimension
| DIMENSION | ASTM D3578-00 | SGMP |
|---|---|---|
| X-SmallSmallMediumLarge | 70 mm +/- 10 mm80 mm +/- 10mm95 mm +/- 10mm111 mm +/- 10 mm | 70 - 75 mm80 - 85 mm90 - 97 mm105 - 111 mm |
| Length | 230 mm minimumfor all sizes | 252mm |
| Thickness -FingerPalm | 0.08mm min0.08mm min | 0.08 mm min0.08 mm min |
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| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP | |
| Mpa | Mpa | % | % | |
| Before Aging | 14.0 | 700 | ||
| X-Small | 27.5 | 850 | ||
| Small | 24.3 | 810 | ||
| Medium | 24.5 | 810 | ||
| Large | 24.7 | 810 | ||
| After Aging | 14.0 | 500 | ||
| X-Small | 29.5 | 930 | ||
| Small | 19.5 | 790 | ||
| Medium | 23.6 | 820 | ||
| Large | 26.5 | 900 |
2. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1125
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 #1125 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBERLEAKED |
|---|---|---|---|---|
| UN-AGED | ||||
| X-Small | 125 | No | 0 | |
| Small | 125 | Yes | 1 | |
| Medium | 125 | Yes | 2 | |
| Large | 125 | Yes | 1 | |
| AGED | ||||
| X-Small | 125 | Yes | 1 | |
| Small | 125 | No | 0 | |
| Medium | 125 | Yes | 3 | |
| Large | 125 | No | 0 |
The above figures are within the draft FDA/ASTM D3578-00 requirements for latex exam gloves of 2.5% AQL.
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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.
12800
| TESTS | FDA INTERNALREQUIREMENT | SGMP's |
|---|---|---|
| Residual PowderContent(ASTM D 6124-00) | 2 mg/glove max | Range: 0.8-1.6mg/gloveMean : 1.2 mg/glove |
| Presence of Cornstarch | Negative | Negative |
5. Total Residual Powder Content & Presence of Cornstarch
6. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-99 | < 50 µg/g | < 50 µg/g |
Conclusion:-
The data presented indicate that the Non-sterile Powder Free Chocolate Scented latex examination glove
-
- meets/exceeds ASTM- D3578-00 Standard Specifications For Latex Examination Glove,
-
- meets FDA pinhole requirements,
- meets FDA claim criterion of a powder free glove. 3.
- meets the protein labeling claim level at <50 µg/g. 4.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2001
SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434
Re: K012860
Trade/Device Name: Powder-Free Latex Examination Gloves with Chocolate Scenting and Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: August 23, 2001 Received: August 23, 2001
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 vour 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not
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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 (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATION FOR USE STATEMENT
Applicant : SGMP Company Limited
510K NUMBER : KO/2840
Device Name : Non-sterile Powder Free Latex Examination Gloves with Chocolate Scent AND PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS ON UESS Indication For Use :
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.
.............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use .............. Per 21 CFR 801.109
OR
Over-The-Counter ... ... ............
Qlin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital,Devices 510(k) Number .
§ 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.