(41 days)
A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powder Free Nitrile Examination Gloves (Polymer Coated)
This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a notification of substantial equivalence for "Powdered Free Nitrile Examination Gloves (Polymer Coated)."
Therefore, I cannot provide the requested information based on the input document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 1998
Mr. Hendra Ramali 'President Director P.T. Latexindo Tobaperkasa Jalan Raya Binjai Km. 11 Medan 20128, Indonesia
Re : K974443 Powdered Free Nitrile Examination Gloves Trade Name: (Polymer Coated) Regulatory Class: I Product Code: LZY Dated: November 25, 1997 Received: November 25, 1997
Dear Mr. Ramali:
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, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಳ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure tocomply with the GMP regulation 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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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 $10 (k) premarket notification. The FDA findinq 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
K. Chatrath
Timoth 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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PT LATEXINDO TOBAPERKASA
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Jalan Raya Binjai Km. 11, Medan 20128, Indonesia Tel. (6261) 851410 / 861471 / 868856 Fax. (6261) 851409 E-mail : Itxindo@indo.net.id
Attachment I
| Indication For Use Statement |
|---|
| ------------------------------ |
| 510(K) Number (if known): | K974443 |
|---|---|
| Device Name: | Powder Free Nitrile Examination Gloves (Polymer Coated) |
| Indication For Use: | A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. |
PT. Latexindo Tobaperkasa
Hendra Ramali
President Director
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | George A. Walls for Chin S. Tan, PhD |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | Office of Device Evaluation (ODE) |
| 510(k) Number | K974443 |
| Prescription Use (Per 21 CFR 801.109) | or Over-The-Counter Use |
(Optimal 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.