(58 days)
This glove is disposable and is intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Smart Fit ; Nitrile Examination Gloves Prepowdered.
This document is a 510(k) premarket notification approval letter for "Smart-Fit, Prepowdered Nitrile Examination Gloves." As such, it does not contain any information about acceptance criteria or a study proving that a device meets those criteria.
The letter is from the FDA to the manufacturer, acknowledging that the device is substantially equivalent to legally marketed predicate devices. This type of notification focuses on regulatory approval based on equivalence for medical devices, not on the detailed performance studies or statistical metrics typically associated with AI/ML device evaluations.
Therefore, I cannot provide the requested information based on the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Foo Khon Pu ·SJ Medical Products (M) Sdn Bhd Lot 723, Batu 5 1/2, Jalan Kapar, Klanq Selangor Darul Ehsan Malaysia
JUL - 3 1997
K971666 Re : Smart - Fit, Prepowdered Nitrile Examination Trade Name: Gloves Requlatory Class: I Product Code: LZA Dated: June 5, 1997 Received: June 9, 1997
Dear Mr. Khon Pu:
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 Requiations, Title 21, Parts 800 to 895. ಸ್ಕಾ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Khon Pu
not affect any obligation you might have under sections 531 noe arress any the Act for devices under the Electronic chiough 542 or the noorol provisions, or other Federal laws or requlations.
This letter will allow yourto begin marketing your device as a described in your 510(k) premarket notification. The FDA described in your sie wire province of your device to a legally marketed predicate device results in a classification for your marketed predicate active 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) 594-4618. 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
the regulation entitled, "Misbranding by reference to 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
Clitatriot
Timb dy A. Ülatowski 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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Image /page/2/Picture/0 description: The image shows a black and white logo. The logo is abstract and features a stylized letter 'S' or a curved shape with a triangular opening at the top right. The design is simple and bold, with clean lines and a geometric feel.
SJ MEDICAL PRODUCTS (M) SDN. BHD.
(Company No. 176287 H)
| 3.0 | Indication For Use Statement. |
|---|---|
| ----- | -------------------------------------- |
INDICATIONS FOR USE
| Applicant | SJ MEDICAL PRODUCTS (M) SDN BHD |
|---|---|
| 510K (Number) | Applied For K971666 |
| Device Name | Smart Fit ® ; Nitrile Examination Gloves Prepowdered. |
Indication for Use: This glove is disposable and is intended for medical purposes
that is worn on the examiner's hand to prevent contamination
between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation ( ODE )
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K971666 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use X |
|---|---|
| --------------------------------------- | --------------------------- |
(Option Format 1 – 2 – 96)
§ 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.