(34 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Synthetic Vinyl Patient Examination Gloves, Beige color(Sensi-Pro)
I am sorry, but the provided text does not contain the information requested to answer the question about the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for disposable powder-free synthetic vinyl patient examination gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices but does not detail acceptance criteria, study methodologies, or performance data beyond the device's intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 2000
Mr. Huan-Chunq Li Vice President Shinemound Enterprise, Incorporated 17A Sterling Road 01862 North Billerica, Massachusetts
K994258 Re : Disposable Powder Free Synthetic Vinyl Trade Name: Patient Examination Gloves with Beige pigment additives (Brand Name: Sensi-Pro) Requlatory Class: I Product Code: in fəsiləsinə cinsinə aid bitki növü.
İstinadlar Respublikasının fəsiləsinə cinsinə aid bitki növü.
İstinadlar Respublikasının fəsiləsinə cinsinə aid bitki növü.
İ December 14, 1999 Dated: December 17, 1999 Received:
Dear Mr. Li:
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 aqainst 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. ਬ 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
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Page 2 - Mr. Li
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 requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a leqally 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
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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timot y 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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Attachment I
INDICATION FOR USE
Applicant: Huan-Chung Li, Shinemound Enterprise, Inc. ઉવ 510K Number(if known): * Device Name: Powder Free Synthetic Vinyl Patient Examination Gloves, Beige color(Sensi-Pro) Indication For Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger 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)
Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96) OR
Over-The-Counter Use
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- For a new submission, do NOT fill in the 510(K) number blank
Roy Auilardh
- For a new submission, do NOT fill in the 510(K) number blank
(Director, Air Traffic Control,
1994218
§ 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.