(46 days)
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.
Powdered patient latex examination gloves
The provided text is a 510(k) premarket notification letter from the FDA regarding "Qualatex Powered Latex Examination Gloves." This document is a regulatory approval for a medical device and does not contain information about the acceptance criteria and study results for an AI/ML powered medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The questions you've asked are specific to the evaluation of AI/ML medical devices, which is not what this document addresses.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 14 1999
Mr. Tan Tiow Gin Director Tan Sin Lian Industries Sdn. Bhd. No. 8, Taman Marin Jalan Haji Abdullah 84000 Muar, Johor, Malaysia
K992557 Re : Qualatex Powered Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: July 24, 1999 Received: July 30, 1999
Dear Mr. Gin:
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 aqainst misbranding and adulteration.
If your device is classified (see aboye) 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 Regulations, Title 21, Parts 800 to 895. ರ್ಗ 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 Failure to comply with the GMP verify such assumptions. 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 through 542 of
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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) 594-4690. 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
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 3.0)
| Applicant | : TAN SIN LIAN INDUSTRIES SDN BHD |
|---|---|
| 510K Number (if known) | : K992557 |
| Device Name | : Powdered patient latexexamination gloves |
| Indications for use | : |
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental Infe control.
Division of Dental, Infer
Control,
and General Hospital D
510(k) Number. K992557
Prescription use Per 21 CFR 801.109 OR Over-The-Counter
§ 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.