(101 days)
According to 21 CFR, a 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.
POWDER FREE LATEX PATIENT EXAMINATION GLOVES
I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for "POWDER FREE LATEX PATIENT EXAMINATION GLOVES" and does not detail acceptance criteria or a study that proves the device meets such criteria. It primarily addresses the regulatory approval of the gloves based on substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Safe Glove Ltd. C/O Ed Sing 4309 West Poinsettia Drive 85304 Glendale, Arizona
JAN 1 6 1998
Re : K973830 Powder Free Latex Patient Examination Glove Trade Name: Requlatory Class: I Product Code: LYY Dated: January 3, 1998 January 7, 1998 Received:
Dear Mr. Sing:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 requlation may result in requlatory action. In addition, FDA may publish further announcements 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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through 542 of the Act for devices under the Electronic enrough Siz of on 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 deborizon in four more of your device of your device to a legally marketed predicate device results in a classification for your marketed predicator mits 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 requlation 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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with a triangle outline. Inside the triangle are the letters 'SG' stacked on top of each other. Below the letters are the words 'บริษัท เซฟโกลฟ จำกัด' and 'SAFE GLOVE CO., LTD.'.
Image /page/2/Picture/1 description: The image shows the words "SAFE GLOVE LTD." in bold, black letters. Above these words are Thai characters, also in bold, black letters. The Thai characters appear to be a translation of "SAFE GLOVE LTD.". The text is clear and easy to read.
Image /page/2/Picture/2 description: The image contains two identical black shapes on a white background. The shapes are abstract and somewhat resemble a stylized bird or a leaf with a curved stem. The shapes are positioned side by side, with a small space between them.
CT BANGKOK 10330. THAILAND.
510(K) Number (if known): K 973830
Device Name: POWDER FREE LATEX PATIENT EXAMINATION GLOVES
Indications For Use: According to 21 CFR, a 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Chine S. Lim
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use$\times$
(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.