(35 days)
A Patient Examination Glove 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.
Powderfree Green Latex Examination Gloves ( Polymer Coated )
This is an FDA Premarket Notification (510(k)) for "Powderfree Latex Examination Gloves (Polymer Coated)". This document is an approval letter and does not contain details about acceptance criteria or a study proving device performance.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/2 description: The image is a black and white circular seal. The seal contains the symbol of the United States Department of Health and Human Services, which is an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.
FEB - 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lim Lee Aik Managing Director SRI Johani Sdn. Bhd. Lot PT 7178, Balakong N/V, 43300 Seri Kembangan, Selangor Darul Ehsan, Malaysia
K980037 Re : Powder Free Latex Examination Gloves Trade Name: (Polymer Coated) Regulatory Class: I Product Code: LYY December 30, 1997 Dated: Received: January 5, 1997
Dear Mr. Aik:
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 of the Act. The general controls provisions 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 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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note:
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Page 2 - Mr. Aik
not affect any obligation you might have under sections 531 not arrect any obligation devices under the Electronic chrough 342 or the norol 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 debtired in your alone of your device to a legally marketed predicate device results in a classification for your markets promiss 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 regulation (ii 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 che regaracion Cheroids, (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. 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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510(k) number(if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Powderfree Green Latex Examination Gloves ( Polymer Coated )
Indications For Use:
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clive Si Lim
(Division Sign Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(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.