(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, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
This document describes the acceptance criteria and performance of the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue and Green).
1. Table of Acceptance Criteria and Reported Device Performance:
| TEST | Acceptance Criteria (ASTM D3578-95) | Reported Device Performance (Cashmere Powder Free Nitrile Exam Gloves) |
|---|---|---|
| Watertight (1000 ml) | GI AQL=4.0% | Pass GI AQL=4.0% |
| Length (mm) | ||
| Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 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 |
| Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| Physical Properties - Before Aging | ||
| Tensile Strength (Mpa) | Min 14 | 16.5 |
| Ultimate Elongation (%) | Min 500 | 550 |
| Physical Properties - After Aging | ||
| Tensile Strength (Mpa) | Min 14 | 23.1 |
| Ultimate Elongation (%) | Min 500 | 520 |
| Powder Content | - (FDA Requirement) | Below 2 mg / glove |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each test. However, the performance data is based on the ASTM D3578-95 standard and the FDA 1000 ml watertight test, which would typically specify sampling plans. The data provenance is from SEAL POLYMER INDUSTRIES SDN. BHD. in Lahat, Perak, Malaysia. The study appears to be a retrospective analysis of product performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For product performance testing against standard specifications like ASTM D3578-95, the "ground truth" is typically defined by the objective measurement procedures within the standard, not by expert consensus on individual cases.
4. Adjudication method for the test set:
Not applicable. The performance data is based on objective measurements and compliance with a standard (ASTM D3578-95) and FDA requirements, not on subjective interpretations 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:
Not applicable. This is a submission for a medical glove, a physical device, and not an AI-powered diagnostic or decision support tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth used for performance evaluation is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578-95 Standard for Rubber Examination Gloves.
- FDA 1000 ml watertight test for pinhole requirements.
- FDA requirements for minimum powder residual content.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device.
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NOV 17 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
| K993134 Attachment M | |
|---|---|
| SMDA 510 (K) SUMMARY | |
| 1.0 | |
| 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, Powder Free NitrileExamination Gloves (Blue)Cashmere Non-Sterile, Powder Free NitrileExamination Gloves (Green) |
| Common Name | Exam Glove |
| Classification Name | Nitrile Patient Examination Glove |
4.0 Identification of The Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.
5.0 Description of The Device
Class 1 Nitrile Patient Examination Glove 80 LZA, powder free 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 M
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 POWDER FREE NITRILE EXAM GLOVES |
|---|---|---|
| 1. Watertight (1000 ml) | GIAQL=4.0% | Pass GIAQL=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 Aging | ||
| Tensile Strength (Mpa) | Min 14 | 16.5 |
| Ultimate Elongation (%) | Min 500 | 550 |
| After Aging | ||
| Tensile Strength (Mpa) | Min 14 | 23.1 |
| Ultimate Elongation (%) | Min 500 | 520 |
| 6. Powder Content | - | Below 2 mg / glove |
Page 2 of 3
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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 M
-
- The performance data of the glove as shown above meet the ASTM D3578-95 Standard and FDA's requirement. Powder content is below 2 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, Powder Free Nitrile Examination Gloves (Blue) and Gashmere Non-Sterile, Powder Free Nitrite Examination Gloves (Green) meet :
- = ASTM D3578-95 Standard
- FDA pinhole requirements
- ・ FDA minimum powder residual content
Page 3 of 3
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 1999
Mr. Chan Chin Hong General Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia
Re : K993134 Cashmere Non-Sterile Blue Powdered Nitrile Trade Name: Examination Gloves Requlatory Class: I Product Code: LZA Dated: October 23, 1999 Received: October 28, 1999
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, Drug, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Hong
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 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 ene regaracton cheroids, "NEWS andalig of "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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Hy A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
K993134 510(K) Number :
: Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue) Device Name Cashmere Non-Sterile, Powder Free 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: ... ... ... ... ... ... .. .. . Per 21 CFR 80.109
OR
Over-The-Counter........\X........
Olim S. hin
(Division Sign-Off) Division of Dental, Infection Con and General Hospita F 1 (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.