(36 days)
A medical gloves i ; worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Not Found
This document is a 510(k) clearance letter from the FDA for "Brothers Vinyl, Powder-Free, Patient Examination Gloves." It does not contain any information about acceptance criteria or a study proving device performance, as is typical for most 510(k) clearances, especially for Class I devices like examination gloves.
The letter explicitly states: "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..." This means the device was cleared because it was shown to be as safe and effective as a legally marketed predicate device, not because a new study was conducted to establish specific performance criteria or benchmarks.
Therefore, I cannot extract the requested information from this document. It is a regulatory clearance, not a technical report detailing performance studies.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three abstract human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 5 1999
Long First (Xiamen) Company, Limited C/O Mr. Stone Chen President Kaohsiung Brothers Products Co. Ltd #23, Kooshan 3rd Road Kaohsiung, Taiwan R.O.C.
K991085 Re : Brothers Vinyl, Powder-Free, Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LYZ Dated: March 26, 1999 March 30, 1999 Received:
Dear Mr. Chen
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 Existing major be subject to such additional controls. requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will Failure to comply with the GMP verify such assumptions. requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 regulations.
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Page 2 - Mr. Chen
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 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.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
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 B
INDICATION FOR USE STATEMENT
510K Number (if kr own): _____________________________________________________________________________________________________________________________________________________ 9 For Name :
Indications For Use :
A medical gloves i ; worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
LONGB FIRST ( Xiamen ) PLASTICS CO., LTD.
Steve Chen
Stone Chen
( PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED )
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Us ર ( Per 21 CFR 8 )1.109 )
Over-The-Counter Use OR
X
Chin S. Lim
Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number
(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.