(562 days)
- The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| TEST | Acceptance Criteria (ASTM D 3578-91 & FDA 1000 ml watertight test) | Reported Device Performance (ONCOLOGY PLUS Powder Free Latex Examination Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | ||
| Size S | min 230 | 295 |
| Size M | min 230 | 293 |
| Size L | min 230 | 298 |
| 3. Palm width (mm) | ||
| Size S | 80 ± 10 | 83 |
| Size M | 95 ± 10 | 94 |
| Size L | 111 ± 10 | 106 |
| 4. Thickness (mm) | ||
| Finger | min 0.08 | 0.27 |
| Palm | min 0.08 | 0.17 |
| 5. Physical Properties | ||
| Before Ageing : | ||
| Tensile Strength (MPa) | min 21 | 25.48 |
| Ultimate Elongation (%) | min 700 | 856 |
| After Ageing : | ||
| Tensile Strength (MPa) | min 16 | 20.81 |
| Ultimate Elongation (%) | min 500 | 969 |
| 6. Powder Content | - (No specific ASTM D 3578-91 criteria listed in this table) | below 2 mg / glove |
| 7. Moisture Content | - (No specific ASTM D 3578-91 criteria listed in this table) | max 0.8% / glove |
| 8. Protein Content | - (No specific ASTM D 3578-91 criteria listed in this table) | below 50 microgram / gram |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each test. However, it references ASTM D 3578-91 and FDA 1000 ml watertight test, which are standard specifications for latex examination gloves and often include sampling plans (e.g., AQL for watertightness). For the watertight test, an "AQL of 1.5" is mentioned, implying a sampling plan was followed.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the study was conducted by WEMBLEY RUBBER PRODUCTS (M) SDN BHD in Malaysia, suggesting the data was generated in Malaysia. Given that these are performance tests of a manufactured product, they are typically prospective in nature, performed on a batch of gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is objective physical and chemical measurements (e.g., length, thickness, tensile strength, protein content) as defined by established standards like ASTM D 3578-91 and the FDA watertight test. These standards themselves are developed by expert consensus in their respective fields.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study that involves human interpretation or diagnosis requiring adjudication. The tests involve objective measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This document describes the performance testing of a medical device (examination gloves) against established physical and chemical standards, not a diagnostic or interpretative AI system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, this is not an algorithm, but a physical product. The tests conducted are standalone in the sense that they evaluate the glove's intrinsic properties without human interaction beyond the testing procedure itself.
7. The Type of Ground Truth Used:
The ground truth used is based on:
- Standardized Specifications: Specifically, the requirements outlined in ASTM D 3578-91 for latex examination gloves.
- Regulatory Requirements: The FDA 1000 ml watertight test requirement.
- Manufacturer's Claims: For powder, moisture, and protein content, the manufacturer established target levels (e.g., "below 2 mg / glove" for powder content). These claims are validated by testing.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI study that involves a "training set." The tests are evaluating the physical properties of a manufactured product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in this context.
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JAN 27 1999
Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are slightly distressed, giving them a textured appearance. The letters are enclosed within a rounded rectangular shape, also in black. The logo has a simple, clean design.
972616
WEMBLEY RUBBER PRODUCTS (M) SDN BHD (No: 147817-V)
l or 1, Jalan 3, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia rketing / QA Tel: (603) 846-1486 / 1867 Fax: (603) 846-1485 / 1557 Operations Tel: (603) 846-1495 / 1496 Fax: (603) 846-1488 / 1608
CONTACT PERSON : MR. Y. W. CHOW
510 (K) SUMMARY
- : ONCOLOGY PLUS POWDER FREE LATEX 1. Trade Name EXAMINATION GLOVES (PROTEIN CONTENT LABEI ING)
-
- Common Name : Examination Gloves
-
- Classification Name : Patient Examination Glove
4. Substantial Equivalence :
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
5. Description of device :
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
6. Intended use of device :
The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body , fluids, waste , or environment.
Page 1 of 3
Image /page/0/Picture/17 description: The image shows a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the top half of the circle, and the letters 'OH' are at the bottom. The logo appears to be a stamp or seal, possibly indicating registration or certification of a manufacturer in Ohio.
Image /page/0/Picture/18 description: The image shows a circular logo with the words "REGISTERED FIRM" around the perimeter. Inside the circle is an inverted triangle shape. Above the triangle is a horizontal line with a small square on top of it.
Image /page/0/Picture/19 description: The image shows a black diamond shape with a white stripe across the top. The word "REGISTERED" is printed in black letters on the white stripe. The diamond shape is oriented with one point facing up and one point facing down.
Image /page/0/Picture/20 description: The image shows the CE marking, which consists of the letters 'C' and 'E'. The 'C' is a simple, curved shape, while the 'E' is also curved but with a shorter middle stroke. This marking indicates that a product conforms to health, safety, and environmental protection standards for products sold within the European Economic Area.
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7. Summary of Performance data :
・・ Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
| TEST | ASTM D 3578-91 | ONCOLOGY PLUS PowderFree Latex ExaminationGloves (Protein ContentLabeling) |
|---|---|---|
| 1.Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | ||
| Size XS | - | - |
| S | min 230 | 295 |
| M | min 230 | 293 |
| L | min 230 | 298 |
| XL | - | - |
| 3. Palm width (mm) | ||
| Size XS | - | - |
| S | $80 \pm 10$ | 83 |
| M | $95 \pm 10$ | 94 |
| L | $111 \pm 10$ | 106 |
| XL | - | - |
| 4. Thickness (mm) | ||
| Finger | min 0.08 | 0.27 |
| Palm | min 0.08 | 0.17 |
| 5. Physical Properties | ||
| Before Ageing : | ||
| Tensile Strength (MPa) | min 21 | 25.48 |
| Ultimate Elongation (%) | min 700 | 856 |
| After Ageing : | ||
| Tensile Strength (MPa) | min 16 | 20.81 |
| Ultimate Elongation (%) | min 500 | 969 |
| 6.Powder Content | - | below 2 mg / glove |
| 7. Moisture Content | - | max 0.8% / glove |
| 8. Protein Content | - | below 50 microgram / gram |
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8. Substantial Equivalence based on assessment of Non-Clinical performance data
The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-91.
Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram.
9. Conclusion
This glove exceed the ASTM D 3578-91 requirements, meet pinhole FDA requirements, and below 50 microgram / gram protein content labeling claim.
Date Summary Prepared : June 16, 1997
Page 3 of 3
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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1999
Mr. Chow Yue Wah Vice President QA/RA Wembley Rubber Products (M) Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
K972616 Re : Oncology Plus Powder-Free Latex Examination Trade Name: Gloves (Protein Content Labeling, (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: November 10, 1998 Received: November 17, 1998
Dear Mr. Chow Yue Wah:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Chow Yue Wah
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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 qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
Directpr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) : __K972614
Device Name : ONCOLOGY PLUS POWDER FREE LATEX EAMINATION GLOVES (PROTF N CONTENT LABELING) 50) IQ ICECC20105 ON LESS
Indications For Use :
-
- The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Concurrence of CDRH, Office of Device Evaluation (ODE)
- The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use OR
Clim 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.