(66 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 Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a and FDA Water leak test.
The provided document describes the acceptance criteria and a study for "Non-Sterile Powder Free, Blue Color Nitrile Examination Gloves" manufactured by GREEN PROSPECT SDN. BHD.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D6319-00a & FDA) | Reported Device Performance (Powder Free Nitrile Exam Gloves) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI, AQL = 2.5 | Pass GI, AQL = 2.5 |
| 2. Length (mm) | XS: Min 220, S: Min 220, M: Min 230, L: Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) | XS: 70 ± 10, S: 80 ± 10, M: 95 ± 10, L: 111 ± 10 | XS: 73-78, S: 83-88, M: 93-98, L: 103-107 |
| 4. Thickness (mm) (Single Layer) | Finger: Min 0.05, Palm: Min 0.05 | Finger: Min 0.08, Palm: Min 0.08 |
| 5. Physical Properties Before Aging | Tensile Strength (MPa): Min 14, Ultimate Elongation (%): Min 500 | Tensile Strength (MPa): 23-26, Ultimate Elongation (%): 700-840 |
| 5. Physical Properties After Aging | Tensile Strength (MPa): Min 14, Ultimate Elongation (%): Min 400 | Tensile Strength (MPa): 18-24, Ultimate Elongation (%): 660-760 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for each individual test (e.g., how many gloves were tested for watertightness or physical properties). However, the performance data is based on "ASTM D6319-00a2 and FDA 1000ML watertight test." ASTM standards typically specify sampling plans. For instance, for watertightness, it specifies an "AQL = 2.5" (Acceptable Quality Limit), which is part of a sampling plan, but not the exact number of units tested.
The data provenance is from Malaysia (Green Prospect Sdn Bhd is located in Perak Darul Ridzuan, Malaysia) and appears to be retrospective in nature, as it's a summary of performance data already collected.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for these tests are the objective measurement standards established by ASTM D6319-00a and FDA regulations, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective measurements against established standards (ASTM and FDA specifications), not subjective assessment requiring adjudication.
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 devices involving human interpretation of data, which is not the case for examination gloves.
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 device is a physical product (examination gloves), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is objective measurement against established industry standards and regulatory requirements. Specifically:
- ASTM D6319-00a: Standard Specification for Nitrile Examination Gloves for Medical Application.
- FDA 1000ML watertight test: A specific regulatory requirement for watertightness.
- FDA Requirements for powder content.
8. The Sample Size for the Training Set
This information is not applicable as this is a physical product evaluated against standards, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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KO31580
GREEN PROSPECT SDN. BHD. (667515-0)
| JUL 2 5 2003 | APPENDIX-J | |
|---|---|---|
| 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 | April 23, 2003 | |
| 3.0 | Name of Device | |
| Trade Name: | Non-Sterile Powder Free, Blue Color Nitrile Examination Gloves | |
| Common Name: | Exam Glove | |
| Classification Name: | Patient Examination Glove | |
| 4.0 | Identification of The Legally Marketed Devices | |
| Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements ofASTM Standard D6319-00a 3 and FDA requirements. | ||
| 5.0 | Description of The Device | |
| Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements ofASTM Standard D6319-00a 3 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. |
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:
... . . . . . . . .
7.0 Summary of Performance Data:
Performance data of gloves based on ASTM D6319-00a2 and FDA 1000ML watertight test.
| TEST | ASTM D6319-00a3 | POWDER FREE NITRILE EXAM.GLOVES | |
|---|---|---|---|
| 1. Watertight (1000ml) | Multiple NormalGIAQL = 2.5 | Pass GI | AQL = 2.5 |
| 2. Length (mm)SizeXSSMLXL | Min 220Min 220Min 230Min 230- | 240 mm minimum for all sizes | |
| 3. Palm width (mm)SizeXSSMLXL | 70 ± 1080 ± 1095 ± 10111 ± 10- | 73-7883 - 8893 - 98103 - 107 | |
| 4. Thickness (mm)(Single Layer)FingerPalm | Min 0.05Min 0.05 | Min 0.08Min 0.08 | |
| 5. Physical PropertiesBefore AgingTensile Strength (MPa)Ultimate Elongation (%)After AgingTensile Strength (MPa)Ultimate Elongation (%) | Min 14Min 500Min 14Min 400 | 23-26700 - 84018-24660 - 760 | |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
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- The performance data of the glove as shown above meet the ASTM D6319-00a" 8.0 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- 9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion
We concluded that the Multiple Private Labeled Non-Sterile Powder Free, Blue Color Nitrile Examination Gloves, meets:
- ASTM D6319-00a63Standard ・
- FDA pinhole requirements -
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00a63
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Image /page/3/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an emblem of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2003
Green Prospect Sdn Bhd C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550
Re: K031580
Trade/Device Name: Non-Sterile, Powder-Free, Blue Color Nitrile Examination Glove Regulation Number: 21 CFR 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 24, 2003 Received: June 27, 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 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,
SeAWitelson
fer
Susan Runner, DDDS, 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:
031580 510K Number:
Device Name: Non-Sterile, Powder-Free, Blue Color Nitrile Examination Glove
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.
Cffluthar
on of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K031580
Concurrence of CDRH Office of Device Evaluation (ODE)
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.