(63 days)
The examination gloves are to be worn by healthcare workers or similar personnel during work to prevent cross contamination between the user and the patient.
Nugard Nitril meet the requirement for examination glove described by the American Standard for Testing and Material ASTM D 3578 with the exception of ultimate elongation before aging. It is blue in color and prepowdered. Sizes available is from XS - XL
This is a 510(k) summary for a Nitrile Examination Glove, not a medical device involving AI or complex performance criteria that would necessitate a study with human readers, ground truth, or intricate statistical analysis. The acceptance criteria for this type of device are primarily based on material properties and basic performance as defined by industry standards.
Here's how to interpret the provided information in the context of the requested table and study details:
Acceptance Criteria and Device Performance for NUGARD Nitrile Examination Glove (K990841)
| Acceptance Criteria (Standard) | Reported Device Performance (NUGARD Nitril) | Study |
|---|---|---|
| ASTM D 3578 | Meets requirements (with one exception) | Non-clinical tests: Conducted per ASTM D3578 and ASTM D512. The specific exception mentioned is "ultimate elongation before aging." The submission states, "Nugard Nitril meet the requirement for examination glove described by the American Standard for Testing and Material ASTM D 3578 with the exception of ultimate elongation before aging. It is blue in color and prepowdered. Sizes available is from XS - XL." Biocompatibility tests: These were also carried out. The summary does not provide specific results but indicates the device meets the requirements. |
| ASTM D 512 | Meets requirements | (See above for Non-clinical tests) |
| Biocompatibility | Tests carried out | (See above for Non-clinical tests). The exact acceptance criteria for biocompatibility are not explicitly detailed here but are implied by the statement "Biocompatibility tests are carried out" and the overall conclusion that the product meets requirements. |
| Prevent cross-contamination | Intended use | This is the intended use, and meeting the physical and barrier properties of ASTM D3578 and D512 supports this claim. No specific "study" is described for directly proving prevention of cross-contamination beyond adherence to the material standards. This is generally assumed for examination gloves that meet relevant standards. |
Detailed Study Information (Based on provided text):
As this is a submission for an examination glove, the "study" described is primarily a series of non-clinical laboratory tests to confirm material properties and safety, rather than a clinical trial or an AI performance study.
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for the ASTM D3578, ASTM D512, or biocompatibility tests.
- Data Provenance: The tests were conducted by the manufacturer, Terang Nusa Sdn Bhd, based in Malaysia. The report does not specify the country of origin of the raw data (e.g., where the gloves were manufactured or where the tests were physically performed, beyond the submitter's location). These are non-clinical (laboratory) tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable for this type of device. "Ground truth" in the context of examination gloves refers to whether the glove physically meets the specified ASTM standards for properties like tensile strength, elongation, barrier integrity (pinholes), biocompatibility, etc. These are objective measurements performed by laboratory technicians/engineers following established protocols, not subjective expert assessment of images or clinical conditions.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in subjective assessments (e.g., by radiologists or clinicians) when establishing ground truth for AI algorithms or clinical trials. The tests for an examination glove are objective measurements against a standard.
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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 question is not applicable. This device is a physical examination glove, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study, human readers, or AI assistance is involved.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device does not involve an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is adherence to established industry standards and specifications (ASTM D3578, ASTM D512) and confirmation through objective laboratory measurements for physical properties, performance, and biocompatibility.
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The sample size for the training set:
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- This question is not applicable. There is no "training set" or corresponding ground truth for this device.
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K990841//A'
Image /page/0/Picture/1 description: The image shows the text "MAY 17" on the left side. On the right side of the image, there is a compass rose graphic. The compass rose has eight points and is black and white.
TERANG NUSA Sdn Bhd
510(k) Summary for NUGARD Nitrile Examination Glove
510(k) Summary
| Submitter Name | Terang Nusa Sdn Bhd |
|---|---|
| Submitter Address | E4(4), Jalan 8Pengkalan Chepa 2 Industrial Zone16100 Kota Bharu,Kelantan, Malaysia. |
| Submitter Telephone | +60 9 7735133 |
| Submitter Fax | +60 9 7737755 |
| Contact Person | LOW, Chin Guan |
| Date of preparation | 8 Mar 99 |
| Trade Name | Nugard Nitril |
| Common Name | Examination Glove |
| Classification | Patient Examination Glove |
| Legally marketed device to whichsubstantial equivalence is beingclaimed. | The Nugard Nitril examination glove described inthis 510(k) is substantially equivalent to the nitrileexamination glove currently being marketed. |
| Description of device | Nugard Nitril meet the requirement forexamination glove described by the AmericanStandard for Testing and Material ASTM D 3578with the exception of ultimate elongation beforeaging. It is blue in color and prepowdered. Sizesavailable is from XS - XL |
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510(k) Summary for NUGARD Nitrile Examination Glove
... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..
| Intended Use of the device | These nitrile examination gloves are to be worn by healthcare workers or similar personnel during work to prevent cross contamination between the user and the patient. |
|---|---|
| Summary of technological characteristics compared to predicate device | This notification describes the similarities to the approved device described. |
| Brief description of non-clinical tests | Test conducted per ASTM D3578, ASTM D512 indicates that the product meet the requirements.Biocompatibility tests are carried out. |
| Brief description of clinical tests | Not carried out |
| Conclusion drawn from clinical and non clinical tests | Not applicable |
| Additional information deemed necessary by the FDA | None |
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Appendix A
Dispenser Box Design
Image /page/2/Figure/2 description: The image shows two views, top and side, of a box of "NUGARD" brand blue nitrile examination gloves. The top view indicates the gloves are disposable, for single use only, prepowdered with absorbable dusting powder, USP, and ambidextrous. The side view includes a caution about residual powder and states the gloves are made from nitrile latex and do not contain natural rubber.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is black.
MAY 17 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chin-Guan Low Managing Director TERANG NUSA Sdn. Bhd. 1 Jalan 8, Pengkalan Chepa 2 Industrial Zone 16100 Kota Bharu, Kelantan, MALAYSIA
K990841 Re: Nugard Nitril® Nitrile Examination Glove Trade Name: Requlatory Class: I Product Code: LZA Dated: March 30, 1999 Received: April 6, 1999
Dear Mr. Chin-Guan Low:
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 regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. 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.
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Page 2 - Mr. Chin-Guan Low
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 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 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,
Timothy A. Ulatowski
Timoťhy) A Ulatowski Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows a compass rose with four points oriented to the cardinal directions. The compass rose is black and white, with the points being black and the background being white. There is a faint outline of a square around the compass rose. The compass rose is a symbol of navigation and direction.
TERANG NUSA Sdn Bhd
510(k) Submission for Nitrile Examination Glove
3. Indication for use Statement
Applicant 510(k) Number Device Name Trade Name
Terang Nusa Sdn Bhd Not available K990841 Patient Examination Glove NUGARD Nitril ® Prepow dered, USP, BLUE
Indication for use
The examination gloves are to be worn by healthcare workers or similar personnel during work to prevent cross contamination between the user and the patient.
Concurrence of CDHR Office of Device Evaluation (ODE)
Burell & Chin
(Division Sign Off) (Division of Dental, Infection Control, and General Hospital Devices 510(k) Number KGA D841
Prescription Use Per 21 CFR 801.109 OR Over the counter
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§ 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.