(70 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.
Powdered Non-Sterile Nitrile Examination Gloves
This document is a 510(k) clearance letter from the FDA for "Powdered Non-Sterile Nitrile Examination Gloves" manufactured by TA CHIA RUBBER IND. CORP. LTD.
It does not describe any acceptance criteria or a study that proves the device meets acceptance criteria. The letter simply states that the FDA has reviewed the 510(k) application and determined the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document is an administrative clearance, not a study report or a description of performance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1999 MAY
Ms. Chin-Ming Yang President TA CHIA RUBBER IND. CORP. LTD. 903, Chung Shan Road Sec. 2, TA Chia, Taichung TAIWAN, R.O.C.
K990575 Re : TA CHIA Powdered Non-Sterile Nitrile Trade Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA । ਭੇਰੇ ਰ February 13, Dated: February 23, 1999 Received:
Dear Ms. Chin-Ming Yang
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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, rood, brag, and of 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 be babyour of bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 vertif boommay 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 premation you might have under sections 531 through 542 of
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Page 2 - Ms. Chin-Ming Yang
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 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.fda//gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Direct 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
510(K) Number (if known): Applied for Device Name: Powdered Non-Sterile Nitrile Examination Gloves
Indications For Use:
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.
Ta Chia Rubber Ind. Corp., Ltd.
Chim CHIN MING YANG /President.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clim S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(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.