(98 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.
SMARTTEX PrePowdered Latex Examination Gloves with Protein claim. (100 MICROGRAM OR LESS) WHITE, BLUE + GREEN
I'm sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for medical gloves and does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily discusses the substantial equivalence of the gloves to previously marketed devices and regulatory compliance.
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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 features a stylized depiction of an eagle or bird-like figure, with flowing lines suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Foo K. Pu Smart Glove Corporation Sdn. Bhd. Lot No. 6487 Mukin Kapar Batu 5¾, Jalan Kapar Klang Selangor Darul Eshan, Malaysia
K974557 Re : SMARTTEX PrePowdered Latex Examination Trade Name: Gloves, White, Blue and Green with Protein Content Labeling Claim (100 Micrograms or Less) Regulatory Class: I LYY Product Code: Dated: January 25, 1998 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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requlations 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 Requlation (QS) for Medical General requlation (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 regulation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Mr. Foo K. Pu
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.
This letter will allow you to beqin marketinq 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) 594-4618. 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
Timotl v 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 words "SMART GLOVE CORPORATION SDN. BHD." in bold, black font. The words are arranged in a single line, with "SMART GLOVE" appearing larger than the rest of the text. The text appears to be a company name or logo.
Company No. 403570 - D
Page 3 of 54
Indications for Use Statement. 3.0
INDICATIONS FOR USE
SMART GLOVE CORPORATION SDN BHD. Applicant :
1974557 510(k) Number
SMARTTEX PrePowdered Latex Examination Gloves with Protein claim. Device Name: (100 MICROGRAM OR LESS) WHITE, BLUE + GREEN
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)
Chin S. Lin
Division Sign-Off Division of Dental, Infection Control, and General Hospital De 510(k) Number
Prescription Use OR Per 21 CFR 801.109
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.