(72 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
SMARTFEEL Pre Powdered Nitrile Examination Gloves (Blue, Green and Natural Colors)
The provided document is a 510(k) premarket notification letter from the FDA regarding "SMARTFEEL Pre Powdered Nitrile Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance in the context of medical devices that require such studies (e.g., AI/ML algorithms, diagnostic tools, or therapeutic devices with performance metrics like sensitivity, specificity, accuracy, etc.).
This document is an approval letter for a Class I medical device, which are typically subject to general controls and substantial equivalence to a predicate device. For examination gloves, the "performance" is generally established through physical properties (e.g., tensile strength, resistance to tearing, barrier integrity) and biocompatibility, often demonstrated through adherence to recognized standards rather than clinical performance studies with specific statistical acceptance criteria as would be described for an AI/ML or diagnostic device.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Image /page/0/Picture/2 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Foo K. Pu Smart Glove Corporation Sdn. Bhd. Lot No. 6487 Mukin Kapar Batu 5¾, Jalan Kapar Klang Selangor Darul Eshan, Malaysia
MAR 1 3 1998
Re: K974907 SMARTFEEL Pre Powdered Nitrile Examination Trade Name: Gloves (Blue, Green and Natural Colors) Requlatory Class: I Product Code: LZA February 25, 1998 Dated: February 27, 1998 Received:
Dear Mr. Foo K. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Foo K. Pu
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 requlations.
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) 594-4618. 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
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,
Timothy A. Ulatowski
Timot 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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Image /page/2/Picture/0 description: The image shows the text "SMART GLOVE CORPORATION SDN. BHD." in a bold, sans-serif font. The words are arranged in two lines, with "SMART GLOVE" on the first line and "CORPORATION SDN. BHD." on the second line. The text is black against a white background, and the overall impression is one of a company name or logo.
Company No. 403570 - D
Page 3 of 52
Indications for Use Statement.
INDICATIONS FOR USE
Applicant : SMART GLOVE CORPORATION SDN BHD.
510(k) Number
Device Name: SMARTFEEL Pre Powdered Nitrile Examination Gloves
Indication For Use :
This glove is disposable and intended for medical purpose 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)
Olin S. Lin
Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K974907
Prescription Use Per 21 CFR 801.109 OR Over-The-Counter : (Optional 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.