(93 days)
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
POWDER FREE BLUE NITRILE GLOVE
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Blue Nitrile Examination Glove". It primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for an AI/ML medical device.
The information requested in the prompt (acceptance criteria, study details, expert involvement, etc.) is typically found in the technical documentation of a medical device submission, particularly for AI/ML devices, and is not part of this FDA clearance letter.
Therefore, I cannot extract the requested information from the provided text.
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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 the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 JUN
Mr. Lim Wee Chai Assistant QA Manager TG MEDICAL SDN. BHD. (Medical Latex Glove Manufacturer and Exporter) Lot. 5091, Jalan Teratai, 5th Miles, Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan MALAYSIA
Re : K990668 Powder Free Blue Nitrile Examination Glove Trade Name: Regulatory Class: I LZA Product Code: Dated: April 21, 1999 Received: April 26, 1999
Dear Mr. Chai:
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, Druq, 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 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 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 verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Chai
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.
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 ene regaracion Shoroson" (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) 638-204) or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The Information, data and labeling claims in the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | TG MEDICAL SDN. BHD. |
|---|---|
| 510(k) Number (if known): | K 990668 EXAMINATION |
| Device Name: | POWDER FREE BLUE NITRILE GLOVE |
Indications For Use:
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IN NEEDDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Qhin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number
ﭼﯿ
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Over-The-Counter
(Optional Formal 1-2-96)
8-8
For a new submission, do NOT fill in the 510(k) number blank.
§ 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.