(62 days)
Latex examination powderfree gloves are worn on the hands of health care and bales examination poracite contamination between health care personnel and the patient.
LATEX EXAMINATION POWDERFREE GLOVES With Protein Labeling Claims (50mg or less)
I am sorry, but the provided text does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The document is an FDA 510(k) clearance letter for "TG Medical Powder-Free Latex Examination Glove," which primarily addresses regulatory equivalence to a predicate device. It explicitly states that "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."
Therefore, I cannot fulfill your request based on the provided input.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures intertwined around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1998
Mr. W. C. Lim Director TG Medical Sdn. Bhd. Lot 5091, Jalan Teratai, 5th Miles, Off Jalan Meru 41050 Klang, Selgangor Darul Ehsan MALAYSIA
K982872 Re : Trade Name: TG Medical Powder-Free Latex Examination Glove Protein Labeling Claim (50 micrograms or Less) Powdered Regulatory Class: I Product Code: LYY Dated: Auqust 10, 1998 Received: August 14, 1998
Dear Mr. Lim:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Lim
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timoth y A. Ulatowsk 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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3.9 Indications for Use Statement: Include the Following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agrees with the Indications for Use statement.
| INDICATIONS FOR USE |
|---|
| ---------------------------- |
| Applicant: | TG MEDICAL SDN. BHD. |
|---|---|
| 510(k) Number (if known): | K982872 |
| Device Name: | LATEX EXAMINATION POWDERFREE GLOVES With Protein Labeling Claims (50mg or less) |
| Indications For Use: |
Latex examination powderfree gloves are worn on the hands of health care and bales examination poracite contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off) Division of Dental, Inis and General Hospital Device
510(k) Number K982872
Prescription Use Por 21 CFR 801. 109 OR
8-8
Over-The-Counter X
(Optional Porcest 1-2.
· For a new submission, do NOT fill in the 510(k) number blank.
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§ 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.