(101 days)
These examination gloves are to be worn by healthcare workers or similar personnel duringwork to prevent cross contamination between the user and the patient.
SENSIFLEX meet the requirement for examination gloves described by the American Standard for Testing and Material ASTM D3578, white in color and non-powdered. Sizes available is from XS -- XL
The provided text describes the 510(k) summary for the TERANG NUSA Sdn Bhd SENSIFLEX Powderfree Latex Examination Glove. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on algorithm performance.
Therefore, many of the requested sections regarding algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable.
Here's an attempt to answer the applicable sections based only on the provided text, and indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the SENSIFLEX Powderfree Latex Examination Glove are based on meeting the requirements of specific ASTM standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D3578 | Product meets requirements |
| ASTM D512 | Product meets requirements |
| Primary Skin irritation test ASTM F 719-81 | Indicates no irritation |
| Dermal sensitization Test ASTM F 720-81 (86) | Indicates no sensitization |
| Starch-free status (Iodine test) | Final product is iodine tested for starch free status. (Implies meeting requirement) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The tests are general performance tests, not clinical studies with a defined patient test set.
- Data Provenance: Not specified in the provided text. The manufacturing company is in Malaysia, but the testing location/origin is not stated. The tests are non-clinical, laboratory-based tests.
- Retrospective/Prospective: Not applicable as these are non-clinical product performance tests, not patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth and expert consensus are not relevant for these types of device performance tests (e.g., tensile strength, sensitivity to irritation). The "ground truth" is defined by the passing criteria of the ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies, particularly with human readers or AI. These are product performance tests.
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 device is an examination glove, not an AI diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an examination glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests is the quantitative and qualitative criteria defined by the specified ASTM (American Standard for Testing and Material) standards for examination gloves and biocompatibility tests. For example, for physical properties like tensile strength, the standard specifies acceptable ranges. For skin irritation/sensitization, the "ground truth" is the observation of no irritation/sensitization.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" and therefore no ground truth established for one.
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TERANG NUSA Sdn Bhd
510(k) Summary SENSIFLEX Powderfree Latex Examination Glove
510(k) Summary
| Submitter Name | Terang Nusa Sdn Bhd |
|---|---|
| Submitter Address | 1, Jalan 8,Pengkalnn 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 | 23 Apr 99 |
| Trade Name | SENSIFLEX |
| Common Name | Latex Examination Glove |
| Classification | Patient Examination Glove |
| Legally marketed device to whichsubstantial equivalence is beingclaimed. | The SENSIFLEX powderfree latex examinationglove described in this 510(k) is substantiallyequivalent to the UNISEAL Gloves, powderfreethat is currently marketed. |
| Description of device | SENSIFLEX meet the requirement for examinationgloves described by the American Standard forTesting and Material ASTM D3578, white in colorand non-powdered. Sizes available is from XS --XL |
| Intended Use of the device | These examination gloves are to be worn byhealthcare workers or similar personnel duringwork to prevent cross contamination betweenthe user and the patient. |
| Summary of technologicalcharacteristics compared tomarketed device | There is no variation in technologicalcharacteristics. |
| Brief description of non-clinicaltests | Test conducted per ASTM D3578, ASTM D512indicates that the product meet the requirements.Primary Skin irritation test ASTM F 719-81Dermal sensitization Test ASTM F 720-81 (86)indicates no sensitization or irritation.Final product is iodine tested for starch free status. |
| Brief description of clinical tests | Not carried out |
| Conclusion drawn from clinical andnon clinical tests | Non-clinical tests and biocompatibility testsindicate device meet all performance andbiocompatibility requirements. |
| Additional information deemednecessary by the FDA | None |
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Image /page/1/Picture/1 description: The image shows a company logo and product information. The company name is TERANG NUSA Sdn Bhd. The text also mentions a 510(k) Summary for SENSIFLEX Powderfree Latex Examination Glove. There is also a handwritten number at the top of the image, K990488.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1999
Mr. Chin-Guan Low Managing Director TERANG NUSA Sdn. Bhd. 1 Jalan 8, Pengkalan Chepa 2 Industrial Zone 16100 Kota Bharu, Kelantan, MALAYSIA
K990488 Re : SENSIFLEX Powder-Free Latex Examination Trade Name: Glove Regulatory Class: I Product Code: LYY Dated: April 26, 1999 Received: April 30, 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 Regulations, 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 regulation may result in regulatory 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 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 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sinal Borges
Timothy A. Ulatowski 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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TERANG NUSA Sdn Bhd
510(k) Submission SENSIFLEX Powderfree Latex Examination Glove
3. Indication for use Statement
Submitter 510(k) Number Device Name Trade Name
Terang Nusa Sdn Bhd Not available K990488 Powderfree Latex Examination Glove SENSIFILEX
Indication for use
1-3
.. .......
These examination gloves are for use by healthcare workers or similar personnel during work to prevent cross contamination or cross infection between the user and the patient.
Concurrence of CDHR Office of Device Evaluation (ODE)
Clins. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.
| Prescription Use | |
|---|---|
| Per 21 CFR 801.109 |
FDA-510(k) SENSIFLEX Exam Gloves
| OR | Over the counter |
|---|---|
| ---- | ------------------ |
Page 6 of 22
§ 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.