(63 days)
Not Found
Not Found
No
The device description and intended use clearly define the product as examination gloves, with no mention of AI or ML capabilities. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No.
The device, examination gloves, is intended to prevent cross-contamination between users and patients, which is a protective function rather than a therapeutic one.
No
The document describes "examination gloves" intended for use by healthcare workers to prevent cross contamination. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states it is an examination glove, which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent cross-contamination between healthcare workers and patients. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM D 3578). There is no mention of any components or functions related to testing samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly described as an examination glove, which is a medical device used for protection and hygiene, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
LZA
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare workers or similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 8 |
| Pengkalan Chepa 2 Industrial Zone | |
| 16100 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 which | |
| substantial equivalence is being | |
| claimed. | The Nugard Nitril examination glove described in |
| this 510(k) is substantially equivalent to the nitrile | |
| examination glove currently being marketed. | |
| Description of device | 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 |
1
Image /page/1/Picture/0 description: The image shows a compass rose with eight points. The compass rose is black and white, and it is oriented with north pointing upwards. There are some dotted lines around the compass rose, which may be part of a design or logo. The image is simple and clear, and it would be easily recognizable as a compass rose.
的一个人的一个人的一个人
TERANG NUSA Sdn Bhd
e produktion programment of the provinsion of the second of the second of the second of the second of the second of the seconding the seconding the section of the section of
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 |
2
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.
3
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.
4
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
5
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
CANV Mitcil C. C., -- 1-- 4: - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -