(58 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 patients' body, fluids, waste or environment.
Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
The provided text describes the acceptance criteria and performance of "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Blue)" and "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Green)" as detailed in the K993133 510(k) submission.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ASTM D3578-95 & FDA) | Reported Device Performance (Cashmere Powdered Nitrile Exam Gloves) |
|---|---|---|
| Watertight (1000 ml) | GI AQL=4.0% | Pass GI AQL=4.0% |
| Length (mm) - Min. for all sizes | Min 230 | 240 mm minimum for all sizes |
| Palm width (mm) - Size XS | - | 75 - 78 |
| Palm width (mm) - Size S | 80 +/- 10 | 82 - 88 |
| Palm width (mm) - Size M | 95 +/- 10 | 92 - 98 |
| Palm width (mm) - Size L | 111 +/- 10 | 102 - 108 |
| Palm width (mm) - Size XL | - | 111 - 115 |
| Thickness (mm) - Finger (Single Layer) | Min 0.08 | 0.10 minimum |
| Thickness (mm) - Palm (Single Layer) | Min 0.08 | 0.10 minimum |
| Before Aging: | ||
| Tensile Strength (Mpa) Before Aging | Min 14 | 30.4 |
| Ultimate Elongation (%) Before Aging | Min 500 | 640 |
| After Aging: | ||
| Tensile Strength (Mpa) After Aging | Min 14 | 30.9 |
| Ultimate Elongation (%) After Aging | Min 500 | 610 |
| Powder Content | <=120 mg /glove | <= 120 mg / glove |
| Biocompatibility (Primary Dermal Irritation) | Pass | Pass |
| Biocompatibility (Guinea Pig Sensitization) | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for watertightness, length, etc.). However, it refers to compliance with ASTM D3578-95 and FDA 1000 ml watertight test, which implicitly defines the sampling plans and methodologies.
The data provenance is not explicitly mentioned as a country of origin for the data itself, but the manufacturer, SEAL POLYMER INDUSTRIES SDN. BHD., is located in Malaysia. The study is a retrospective evaluation of the product's performance against established standards, not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The "ground truth" for the performance criteria is established by the specified industry standards (ASTM D3578-95 and FDA guidelines) rather than expert consensus on individual cases. These standards define the measurable thresholds for passing or failing each test.
4. Adjudication Method for the Test Set:
This information is not applicable in the context of these device performance tests. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations where human consensus on an interpretation of a medical image or condition is required. For the physical and chemical properties of gloves, the results are objective measurements against defined criteria.
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:
No, an MRMC comparative effectiveness study was not done. This type of study is irrelevant for the evaluation of examination gloves, which are physical devices with measurable performance characteristics, not diagnostic AI systems assisting human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This question is also irrelevant as the device is a physical examination glove, not an algorithm. The "performance" described is the physical and chemical properties of the glove itself, not an algorithm's output.
7. The Type of Ground Truth Used:
The ground truth used is primarily industry standards and regulatory requirements. Specifically:
- ASTM D3578-95 Standard: This standard defines the physical requirements and test methods for rubber examination gloves.
- FDA 1000 ml watertight test: A specific regulatory requirement for glove integrity.
- FDA minimum powder content: A specific regulatory requirement for powder levels in gloves.
- Biocompatibility tests: These tests (Primary Dermal Irritation Test and Guinea Pig Sensitization) adhere to established protocols to determine a material's biological compatibility.
8. The Sample Size for the Training Set:
This information is not applicable as there is no "training set" in the context of evaluating the physical properties of a medical device like examination gloves. Training sets are used for machine learning models.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set involved.
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NOV 1 7 1999
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
Attachment H
SMDA 510 (K) SUMMARY
| 2.0 | Submitter | SEAL POLYMER INDUSTRIES SDN BHDLot 72706, Jalan LahatKawasan Perindustrian Bukit Merah31500 Lahat, Perak, Malaysia |
|---|---|---|
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Mr. CHAN CHIN HONG | |
| Date of Summary Prepared | September 4, 1999 | |
| 3.0 | Name of Device | |
| Trade Name | Cashmere Non-Sterile, Powdered NitrileExamination Gloves (Blue)Cashmere Non-Sterile, Powdered NitrileExamination Gloves (Green) | |
| Common Name | Exam Glove | |
| Classification Name | Patient Examination Glove |
4.0 Identification of The Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.
5.0 Description of The Device
1.0
Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
6.0 The Intended Use of Glove
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
Attachment H
7. Summary of Performance Data :
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-95 | CASHMERE POWDERED NITRILE EXAM GLOVES | |
|---|---|---|---|
| 1. | Watertight (1000 ml) | GI AQL=4.0% | Pass GI AQL=4.0% |
| 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 | - | 75 - 78 |
| S | 80 +/- 10 | 82 - 88 | |
| M | 95 +/- 10 | 92 - 98 | |
| L | 111 +/- 10 | 102 - 108 | |
| XL | - | 111 - 115 | |
| 4. | Thickness (mm)(Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum | |
| Palm | Min 0.08 | 0.10 minimum | |
| 5. | Physical PropertiesBefore AgingTensile Strength (Mpa) | Min 14 | 30.4 |
| Ultimate Elongation (%) | Min 500 | 640 | |
| After AgingTensile Strength (Mpa) | Min 14 | 30.9 | |
| Ultimate Elongation (%) | Min 500 | 610 | |
| 6. | Powder Content | <=120 mg /glove | <= 120 mg / glove |
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SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
Attachment H
- The performance data of the glove as shown above meet the ASTM D3578-95 8. Standard and FDA's requirement. Powder content is below 120 mg per glove which meet the FDA Requirements.
-
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Blue) and Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Green) meet :
- ASTM D3578-95 Standard -
- -FDA pinhole requirements
- -FDA minimum powder content
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1999
Mr. Chan Chin Hong General Manaqer Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia
Re: K993133 Non-sterile Powdered Nitrile Examination Trade Name: Gloves (Blue) Regulatory Class: I Product Code: LZA Dated: September 17, 1999 September 20, 1999 Received:
Dear Mr. Hong:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Hong
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general 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.fdaggov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
r A. Ulatowski Timoth 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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INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
Kag3133 510(K) Number :
Device Name : Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Blue) Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Green)
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 patients' body, fluids, waste or environment.
Concurrence of CDRH Office of Device Evaluation (ODC) Prescription Use: ... ... ... ... ... ...... OR Over-The-Counter ... . .. ... ... ... Per 21 CFR 80.109 (Division Sign-Off)
..............................................................................................................................................................................
Division of Dental, Infection Control and General Hospita 510(k) Number .
Page 4
§ 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.