(65 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 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water leak test.
Here's a breakdown of the acceptance criteria and study information for the Green Prospect Sdn Bhd Non-Sterile Powder Free, Latex Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-01 & FDA) | Reported Device Performance | Comments |
|---|---|---|---|
| Pinhole (Watertightness) | AQL = 2.5 (1000ml) | Pass GI, AQL = 2.5 | Meets standard |
| Length (mm) | Min 220 (XS, S), Min 230 (M, L) | 240 mm minimum for all sizes | Exceeds standard |
| Palm Width (mm) | 70 ± 10 (XS), 80 ± 10 (S), 95 ± 10 (M), 111 ± 10 (L) | 73 - 78 (XS), 83 - 88 (S), 93 - 98 (M), 103 - 107 (L) | Within specified ranges |
| Thickness (mm)(Single Layer) | Finger: Min 0.08Palm: Min 0.08 | Finger: Min 0.10Palm: Min 0.10 | Exceeds standard |
| Physical Properties (Before Aging) | Tensile Strength (MPa): Min 18Ultimate Elongation (%): Min 650Stress at 500% Elongation: Max 5.5 | Tensile Strength (MPa): 22 - 24Ultimate Elongation (%): 820 - 900Stress at 500% Elongation: 2.2 - 2.9 | Exceeds/meets standard |
| Physical Properties (After Aging) | Tensile Strength (MPa): Min 14Ultimate Elongation (%): Min 500 | Tensile Strength (MPa): 22 - 24Ultimate Elongation (%): 800 - 860 | Exceeds standard |
| Powder Content | Max 2.0 mg/glove | Below 2 mg/glove | Meets standard |
| Protein Content | Max 50 micrograms/gram | Below 50 micrograms/gram | Meets standard |
| Biocompatibility | Pass Primary Dermal Irritation Test, Pass Guinea Pig Sensitization (Buehler) test | Pass Biocompatibility Test | Meets standard |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, it references ASTM D3578-01, which is a standard specification for rubber examination gloves. This standard outlines procedures for sampling and testing. For example, for watertightness, it specifies an Acceptance Quality Limit (AQL) of 2.5, which implies a sampling plan where a certain number of gloves are tested from a lot, and the number of failures must not exceed a specified threshold for the lot to be accepted.
The data provenance is from Green Prospect Sdn Bhd, Malaysia. The studies appear to be retrospective in the sense that the data presented are the results of tests already conducted to demonstrate compliance with existing standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable in this context. The "ground truth" for medical gloves is established by predefined ANSI/ASTM and FDA standards and requirements, not through expert consensus on qualitative assessments. The tests are objective measurements against these established quantitative limits.
4. Adjudication Method for the Test Set
This is not applicable. The tests performed on medical gloves are objective and quantitative measurements (e.g., length, thickness, tensile strength, protein content). The results are compared directly to the numerical acceptance criteria defined in the relevant standards (ASTM D3578-01 and FDA requirements). There is no subjective interpretation requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance, comparing human reader performance. This device is a medical glove, and its performance is assessed through physical and chemical property testing, not through human interpretation of cases.
6. Standalone (Algorithm Only) Performance
This is not applicable. This device is a physical product (medical glove), not an algorithm or software. Its performance is inherent in its physical and chemical properties, measured directly through laboratory testing.
7. Type of Ground Truth Used
The ground truth used for evaluating the device is based on pre-established industry standards and regulatory requirements:
- ASTM D3578-01 Standard Specification for Rubber Examination Gloves
- FDA Pinhole Requirements
- FDA Minimum Powder Residual Content
- Label Claim of maximum 50 micrograms per gram of glove or less for water extractable protein.
- Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test).
8. Sample Size for the Training Set
This is not applicable. This device is a manufactured product (medical glove), not an AI/ML model or a diagnostic algorithm that requires a "training set" in the context of machine learning. The testing described is for product quality control and regulatory compliance.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons mentioned in point 8.
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K03158/
| GREEN PROSPECT SDN. BHD. (567515-D) |
|---|
| ------------------------------------- |
| JUL 24 2003 |
|---|
| ------------- |
APPENDIX-K
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | Green Prospect Sdn BhdLot 14803, Kawasan PerindustrianKg. Acheh, Sitiawan, LumutPerak Darul RidzuanMALAYSIA |
| Tel | 605-6911288 | |
| Fax | 605-6922388 | |
| Name of Contact Person | 1. MS. WONG YOKE CHENG | |
| Date of Summary Prepared | March 20, 2003 | |
| 3.0 | Name of Device | |
| Trade Name | Non-Sterile Powder Free, Latex Examination Gloves, Polymer CoatedWhite Color, with Protein Labeling, Contains 50 Micrograms or Less ofTotal Water Extractable Protein Per Gram(Multiple Private Labels): | |
| Common Name | Exam Glove | |
| Classification Name | Patient Examination Glove | |
| 4.0 | Identification of The Legally Marketed Devices | |
| Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all therequirements of ASTM Standard D3578-01 and FDA requirements. | ||
| 5.0 | Description of The Device | |
| Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all therequirements of ASTM Standard D3578-01 and FDA Water leak test. | ||
| 6.0 | The Intended Use of Glove | |
| A medical glove is worn on the hand of healthcare and similar personnel to preventcontamination between healthcare personnel and the patient's body, fluids, waste orenvironment. | ||
| Page 1 of 3 |
Lot 14803, Kawasan Perindustrian, Kampung Acheh, 32000 Sitiawan, Perak Darul Ridzuan, Malaysia.
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Summary of Performance Data: 7.0
ﺮ
r
Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.
| TEST | ASTM D3578-01 | POWDER FREE LATEX EXAM. GLOVES | |
|---|---|---|---|
| 1. Watertight (1000ml) | Multiple NormalGIAQL = 2.5 | Pass GI | AQL = 2.5 |
| 2. Length (mm)Size XSSMLXL | Min 220Min 220Min 230Min 230- | 240 mm minimum for all sizes | |
| 3. Palm width (mm)Size XSSMLXL | $70 \pm 10$$80 \pm 10$$95 \pm 10$$111 \pm 10$- | 73 - 7883 - 8893 - 98103 - 107. | |
| 4. Thickness (mm)(Single Layer)FingerPalm | Min 0.08Min 0.08 | Min 0.10Min 0.10 | |
| 5. Physical PropertiesBefore AgingTensile Strength (MPa)Ultimate Elongation (%)Stress at 500% ElongationAfter Aging | Min 18Min 650Max 5.5 | 22 - 24820 - 9002.2-2.9 | |
| Tensile Strength (MPa)Ultimate Elongation (%) | Min 14Min 500 | 22 - 24800 - 860 | |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove | |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
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The performance data of the glove as shown above meet the ASTM D3578-01 8.0 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. The protein content tested on accelerated aging gloves is ≤ 50 mg/gram.
- The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig 9.0 Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- Conclusion 10.0
We concluded that the Multiple Private Labeled Non-Sterile Powder Free, Latex Examination Gloves, Polymer Coated Natural and/or Colored with Protein Labeling, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram meets:
- ASTM D3578-01 Standard -
- FDA pinhole requirements -
- FDA minimum Powder Residual Content. -
- Label Claim of maximum 50 micrograms per gram of glove or less for water ﺖ Extractable Protein.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an eagle or a bird in flight, composed of three curved lines. The emblem is positioned in the upper right portion of the circle.
Public Health Service
JUL 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Green Prospect Sdn Bhd C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550
Re: K031581
Trade/Device Name: Non-Sterile Powder Free, Latex Examination Gloves, Polymer Coated White Color with Protein Labeling, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 3, 2003 Received: July 7, 2003
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.
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Page 2 - Mr. 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 (OS) 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,
fAWit-h
for
san Runner, DDS, MA Interim 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
Green Prospect Sdn Bhd Applicant:
KO31581 510K Number:
Device Name: Non-Sterile Powder Free, Latex Examination Gloves, Polymer Coated White Color, with Protein Labeling, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
Indications 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)
costh
ion of Anesthesiology. G Infection Control. Den
510(k) Number: K031581
Prescription Use .................................... Per 21 CFR 801.109
OR
Over-The-Counter .................
§ 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.