(78 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"3 and FDA Water Leak Test.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D6319-00aE3) | Reported Device Performance (Powder Free Nitrile Exam Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | GI AQL=2.5% | Pass GI AQL=2.5% |
| 2. Length (mm) | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) | Depends on size: | Depends on size: |
| Size XS | - | <80 mm |
| Size S | 80 +/- 10 | 85 +/- 3 mm |
| Size M | 95 +/- 10 | 95 +/- 3 mm |
| Size L | 111 +/- 10 | 105 +/- 3 mm |
| Size XL | - | 111 +/- 3 mm |
| Size XXL | - | 120 +/- 3mm |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.05 | 0.08 minimum |
| Palm | Min 0.05 | 0.08 minimum |
| 5. Physical Properties | ||
| Before Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 21.8 |
| Ultimate Elongation (%) | Min 500 | 620 |
| After Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 25.7 |
| Ultimate Elongation (%) | Min 400 | 584 |
| 6. Powder Content | (Not explicitly specified in table as min/max) | Below 2mg / glove |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It refers to "Attachment C" for the average numbers of physical properties but this attachment is not provided.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. It summarises performance data based on ASTM D6319-00a53 and FDA 1000 ml watertight test, implying a laboratory-based testing environment.
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 tests performed are standardized material property tests (ASTM D6319-00aE3 and FDA 1000 ml watertight test), which typically involve laboratory technicians or engineers, not "experts" in the medical sense for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are standardized physical and performance tests, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable as this device is a medical glove, not an AI-assisted diagnostic or imaging system involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as this device is a medical glove, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by standardized laboratory testing protocols and specifications outlined in ASTM D6319-00aE3 and the FDA 1000 ml watertight test. This is essentially objective physical and performance measurements against predefined benchmarks.
8. The Sample Size for the Training Set
This information is not applicable as this device is a physical product (medical glove) and does not involve machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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K-050528
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
MAY 1 9 2005
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | SPI GLOVES SDN. BHD.5, Persiaran Greentown 8,Greentown Business Centre,30450 Ipoh, Perak, Malaysia |
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Ms. CHUN CHOOI FONG | |
| Date of Summary Prepared | February 24, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Powder Free Nitrile Examination Glove | |
| Common Name | Exam Glove |
4.0 Identification of the Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a43 and FDA requirements.
Nitrile Patient Examination Glove
Description of The Device 5.0
Classification Name
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"3 and FDA Water Leak Test.
The Intended Use of Glove 6.0
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
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SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
7. Summary of Performance Data:
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
| TEST | ASTM D6319-00aE3 | POWDER FREE NITRILE EXAM GLOVES |
|---|---|---|
| 1. Watertight (1000 ml) | G IAQL=2.5% | Pass GlAQL=2.5% |
| 2. Length (mm)Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm)Size XS | - | <80 mm |
| S | 80 +/- 10 | 85 +/- 3 mm |
| M | 95 +/- 10 | 95 +/- 3 mm |
| L | 111 +/- 10 | 105 +/- 3 mm |
| XL | - | 111 +/- 3 mm |
| XXL | - | 120 +/- 3mm |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.05 | 0.08 minimum |
| Palm | Min 0.05 | 0.08 minimum |
| 5. Physical Properties | ||
| Before AgingTensile Strength (Mpa) | Min 14.0 | *21.8 |
| Ultimate Elongation (%) | Min 500 | *620 |
| After AgingTensile Strength (Mpa) | Min 14.0 | *25.7 |
| Ultimate Elongation (%) | Min 400 | *584 |
| 6. Powder Content | Below 2mg / glove |
- The average number obtained from Attachment C.
Page 2 of 3 ATTACHMENT P
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2005
Ms. Chooi Fong Chun Quality Management System Manager SPI Gloves Sdn. Bhd. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, MALAYSIA
Re: K050528
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, White, Violet, Pink, Green, Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 5, 2005 Received: May 9, 2005
Dear Ms. Chun:
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 Ameridate connants, 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 approvisions 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 (1 mr.), it hay ob adjoco in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device of a may publish further announcements concerning your device in the Eederal Register.
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Page 2 - Ms. Chun
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issualled of a baseaux and other with other requirements mean that FDA nas made a determinations administered by other Federal agencies. of the Act of ally receital statutes and regurements, including, but not limited to: registration You must conting with an the Hood reg (21 CFR Part 801); good manufacturing practice and listing (21 CFK Pat 807), laboling (21 CFR Partialion (21 CFR Part 820); and if requirements as set form in the quality byotents (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) I his letter will anow you to begin mailitaling of substantial equivalence of your device to a premarket notification. - The PDF Intelling or 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), If you desire specific advice to: Joiasce 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 may obtain other general miorinational and Consumer Assistance at its toll-free Division of 01 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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INDICATIONS FOR USE STATEMENT
: SPI Gloves Sdn. Bhd. Applicant
KOZOZZ V 510(K) Number :
: Powder Free Nitrile Examination Gloves (Blue, White, Violet, Pink, Device Name Green, Black)
Indication For Use:
A patient examination glove is a disposable device intended for medical purposes that is worn A patient examiner's hands or finger to prevent contamination between patient and examiner.
on the examiner's hands or finger to prevent contamination between patient and exa
............................................................................................................................................................................ Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ........................................ Per 21 CFR 80.109
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Shiela M. Murphy KP
sion Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, DIVIsion Of Ancolnoental Devices
infection control.
510(k) Number: K950528
§ 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.