(67 days)
A medical glove is 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 a medical device: "Teh Loong Vinyl, Powder-Free Patient Examination Glove." It is not a study report, and therefore does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device is considered safe and effective because it is similar enough to existing devices that have already been cleared by the FDA. The letter does not describe any specific studies performed by the manufacturer to prove performance against acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Mr. T.H. Chen, President Teh Loong Corporation No. 18, Chin Liu Street Shiaukang District Kaohsiunq, Taiwan, R.O.C.
K993849 Re : Trade Name: Teh Loong Vinyl, Powder-Free Patient Examination Glove Requlatory Class: I Product Code: LYZ November 10, 1999 Dated: November 12, 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, qood 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 Regulations, Title 21, Parts 800 to 895. ਖ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
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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.
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 leqally 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.fdaggov/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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INDICATION FOR USE STATEMENT
K 993840 510K Number (if known): _ Yinyl Powdered-Free Patient Examination Gloves. Device Name :
Indications For Use :
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
LONGBEST ( XIAMEN ) BALLS CO., LTD.
7.H.Chen.
T.H. Chen
( PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ ( Per 21 CFR 801.109 )
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Cor and General Hospital I 510/k) Number
§ 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.