(9 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between parpose nation and examiner.
Not Found
The requested information is not available in the provided text. The document is a 510(k) substantial equivalence letter from the FDA for "Powder-Free Vinyl Exam Gloves." It does not contain details about specific acceptance criteria or a study proving the device meets those criteria. Instead, it confirms that the device is substantially equivalent to a legally marketed predicate device based on its intended use.
The document discusses regulatory information, labeling requirements, and contact information, but not performance study data of the type requested.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services, USA. The seal is circular and features the department's logo in the center. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 - 2005
Baoding Guanzhong Glove Company Limited c/o Mary Ann Doucette Doucette Medical Supply, LLC 10 Seton Court Rancho Mirage, California 92270
Re: K052006
Trade/Device Name: Powder-Free Vinyl Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: May 25, 2005 Received: July 28, 2005
Dear Ms. Doucette:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, aDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Doucette
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to I legal|v marketed predicate device results in a classification for your device and thus, perrorts your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note (21 Cr (1 t u regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours.
Chris Van Tine
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
... ...
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between parpose nation and examiner.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule H. Murkey, MD 8/3/05
sthesiology. General I
510(k) Number: K152006
§ 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.