(133 days)
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON-THE EXAMINER*S WAND TO PREVENT CONTAMINATION™ BETWEEN PATIENT AND EXAMINER.
POWDER-FREE LATEX EXAMINATION GLOVES
The provided text is a 510(k) premarket notification letter from the FDA regarding "Latex Examination Gloves, Powderfree." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail performance acceptance criteria or a study's findings.
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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 caduceus, which is a symbol of medicine, with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 1997
Mr. Clement K.K. Oon Executive Director Oon Corporation Resources (M) SDN BHD-Lot No. 59, Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus Malaysia
Re : K970770 Latex Examination Gloves, Powderfree Trade Name: Regulatory Class: I Product Code: LYY Dated: May 8, 1997 Received: June 16, 1997
Dear Mr. Oon:
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. ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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. 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
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Page 2 - Mr. Oon
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 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,
K. Olstad
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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FDA/QDE/DDIGD
K970770 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: POWDER-FREE LATEX EXAMINATION GLOVES
Indications For Usc:
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON-THE EXAMINER*S WAND 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 Genera! Hospital Devices
5:04) Number K970770
Prescription Use (Pcr 21 CFR 801.109) OR
Over-The-Counter Use V
(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.