(150 days)
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powder Free Latex Patient Examination Gloves
This document, a 510(k) premarket notification from the FDA, deals with the regulatory clearance of "Powder Free Latex Patient Examination Gloves". It focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a study demonstrating the device's performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the provided text. The document confirms the device's clearance for marketing, but does not detail performance studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Prachai Konqwaree President Comp Mech, Incorporated 8186 East Del Cuarzo Drive Scottsdale, Arizona 85258
AUG 2 9 1997
Re : K971200 Powder Free Latex Patient Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: July 29, 1997 Received: August 4, 1997
Dear Mr. Kongwaree:
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. A 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 requlation (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 regulation may result in regulatory 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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Page 2 - Mr. Konqwaree
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 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 Radiological Health
Enclosure
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Attachmet I
Indication For Use Statement
510k Number (if known):_______________________________________________________________________________________________________________________________________________________ Device Name: Powder Free Latex Patient Examination Gloves Indications For Use:
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
W.A.RUBBERMATE CO.,LTD
PRACHAI KONGWAREE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of Device Evaluation (ODE)
Sign incurrence of CDRH.Office of Device Evaluat
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices,
510(k) Number. K971200
Prescription Use __ OR Over-The-Counter Use X
(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.