(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.
Class I latex patient examination glove 80LZA, powder free Modical Archicetion, executively of ASTM Class I latex patient examination grove 80224, power 1100 million Application, except for the elongation at break parameter.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: POWDER FREE GREEN COLOR SYNTHETIC EXAM GLOVES (also referred to as Non-Sterile Powder Free Purple Latex Examination Glove with Blueberry Scented and Protein Content Labeling Claim)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | Width (X-Small, Small, Medium, Large) | ASTM D3578-99: +/- 10mm (e.g., 70 +/- 10mm for X-Small) | SGMP: Within specified ranges (e.g., 70-75mm for X-Small) |
| Length | 230mm minimum for all sizes | SGMP: 242mm | |
| Thickness - Finger | 0.08mm min | SGMP: 0.08mm min | |
| Thickness - Palm | 0.08mm min | SGMP: 0.08mm min | |
| Physical Properties | Tensile Strength (Before Aging) | ASTM-D3578-00: 14.0 Mpa | SGMP: 25.3, 26.0, 28.9, 22.0 Mpa (for X-Small, Small, Medium, Large respectively) |
| Ultimate Elongation (Before Aging) | ASTM-D3578-00: 700% | SGMP: 840, 850, 860, 840 % (for X-Small, Small, Medium, Large respectively) | |
| Tensile Strength (After Aging) | ASTM-D3578-00: 14.0 Mpa | SGMP: 21.3, 23.4, 23.6, 21.7 Mpa (for X-Small, Small, Medium, Large respectively) | |
| Ultimate Elongation (After Aging) | ASTM-D3578-00: 500% | SGMP: 890, 930, 940, 900 % (for X-Small, Small, Medium, Large respectively) | |
| Water Tight Test | Leakage (AQL) | 2.5% AQL (FDA/ASTM D3578-00 requirements) | SGMP: Leaked Status with counts of 0-2 (e.g., 2 for un-aged X-Small, 0 for un-aged Small) – "The above figures are within the gloves of 2.5% AQL." |
| Biocompatibility | General Biocompatibility | Pass relevant tests for examination gloves | SGMP: Passed the tests (as per Appendix L, not provided here) |
| Powder Content | Residual Powder Content (ASTM D 6124-00) | 2 mg/glove max (FDA Internal Requirement) | SGMP: Range: 0.6-1.2 mg/glove; Mean: 0.9 mg/glove |
| Presence of Cornstarch | Negative (FDA Internal Requirement) | SGMP: Negative | |
| Protein Level | Residual Protein Level (ASTM D 5712-95) | < 50 µg/g (FDA Allowable Level) | SGMP: < 50 µg/g (Claimed Level) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Water Tight Test: 125 pieces per size for both un-aged and aged conditions (Total = 125 * 4 sizes * 2 conditions = 1000 gloves).
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It is a submission for a 510(k) premarket notification to the FDA, suggesting the data was generated specifically for this application, making it likely prospective testing conducted by the manufacturer (SGMP).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the described device (examination gloves) does not involve medical interpretation or diagnostic tasks that would require expert ground truth establishment in the traditional sense of image analysis or clinical diagnosis. The "ground truth" for this device is based on objective, standardized physical and chemical tests (e.g., measuring dimensions, tensile strength, water leaks, powder content, protein levels) against established ASTM and FDA standards.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data to resolve discrepancies. For physical device performance testing, the results are typically quantitative measurements against objective standards, not subjective interpretations requiring adjudication.
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. This type of study is relevant for diagnostic or AI-assisted interpretation systems where human performance is measured with and without AI. This document pertains to the performance of a physical medical device (examination gloves) against established physical and chemical standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. The device is a physical product (examination gloves), not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on objective, quantitative measurements against established industry and regulatory standards. Specifically:
- ASTM Standards: ASTM D3578-99, ASTM D3578-00, ASTM D6124-00, ASTM D5712-95.
- FDA Requirements: FDA specified 1,000 ml water leak test, FDA internal requirement for powder, FDA allowable level for protein.
These standards define the acceptable range or threshold for various physical and chemical properties of examination gloves.
8. The Sample Size for the Training Set:
This information is not applicable. The device is an examination glove, not a machine learning model or an AI algorithm that requires a "training set." The tests described are for product validation against specifications, not for training a predictive model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as #8. There is no training set for this type of device.
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APPENDIX K
K0128
9/21/01
510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR SUMMARY OF THE SALES I THE SALET I THE TIC EXAMINATION GLOVES
Contact person : Ong Lay Mau
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Device Information:
Device Information:
Trade Name - POWDER FREE GREEN COLOR SYNTHETIC EXAM GLOVES
Common Name - Exam gloves
Common Name - Patient examination glove (per 21 CFR 880.6250)
Classification Name - Patient examilation gover (per of or other 80LY ) remination Gloves for Medical Classification Information - Class I latex paned Cancification for Latex Examination Gloves for Medical the requirements of the elongation at break parameter.
Device Description:
Device Description:
Class I latex patient examination glove 80LZA, powder free Modical Archicetion, executively of ASTM Class I latex patient examination grove 80224, power 1100 million Application, except for the elongation at break parameter.
Intended Use of Device:
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.
Technological Characteristics of Device:
1. Dimension
| DIMENSION | ASTM D3578-99 | Shield Gloves |
|---|---|---|
| X-SmallSmallMediumLarge | 70 mm +/- 10 mm80 mm +/- 10mm95 mm +/- 10mm111mm +/- 10mm | 70 - 75 mm80 - 85 mm90 - 97 mm105 - 111 mm |
| Length | 230 mm minimumfor all sizes | 242mm |
| 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 | |
| Before AgingX-SmallSmallMediumLarge . | Mpa14.0 | Mpa25.326.028.922.0 | %700 | %840850860840 |
| After AgingX-SmallSmallMediumLarge | 14.0 | 21.323.423.621.7 | 500 | 890930940900 |
Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) 2. on Lot# 1128
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 #1128 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBERLEAKED |
|---|---|---|---|---|
| UN-AGED | X-Small | 125 | Yes | 2 |
| Small | 125 | No | 0 | |
| Medium | 125 | Yes | 1 | |
| Large | 125 | No | 0 | |
| AGED | X-Small | 125 | Yes | 1 |
| Small | 125 | Yes | 2 | |
| Medium | 125 | Yes | 1 | |
| Large | 125 | No | 0 |
The above figures are within the gloves of 2.5% AQL.
FDA/ASTM D3578-00 requirements for latex exam
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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.
5. Total Residual Powder Content & Presence of Cornstarch
| TESTS | FDA INTERNALREQUIREMENT | SGMP's |
|---|---|---|
| Residual PowderContent(ASTM D 6124-00) | 2 mg/glove max | Range: 0.6-1.2g/gloveMean : 0.9mg/glove |
| Presence of Cornstarch | Negative | Negative |
Residual Protein Level 6.
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-95 | < 50 $ \mu $ g/g | < 50 $ \mu $ g/g |
Conclusion :-
The data presented indicate that the Non-sterile Powder Free Purple latex examination glove with blueberry scent
I. meets/exceeds ASTM- D3578-99 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
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: K012857
Trade/Device Name: Non-Sterile Powder Free Purple Latex Examination Glove with Blueberry Scented 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 22, 2001 Received: August 24, 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 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 I least 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. or the rice of ally 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) rine reter 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.
Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
Applicant : SGMP Company Limited
10/2857 510K NUMBER :
Device Name : Non-sterile Powder Free Purple Latex Examination Gloves with Blueberry DEVEL HALLE PROFENT CONTENT LABELING CLAIM ( 50 MICROGRAMS OR LESS )
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
2
Over-The-Counter ... .
Cl. Cl
(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.