(32 days)
A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
NITRILE LATEX EXAMINATION GLOVES, POWDERFREE
The provided text is a 510(k) premarket notification letter from the FDA to Innovative Gloves Company, Ltd. regarding their Nitrile Examination Gloves, Powderfree. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Instead, it's a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It references an "Indications for Use" enclosure (which is provided in the third image) but does not detail the technical performance or testing methodology.
Therefore, I cannot extract the requested information from the provided text because it is not present.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Mr. Rajeev Kumar Sood President & CEO Innovative Gloves Company, Ltd. 11, Chotevittayakul 3 Road Khohong, Hatyai Songkhla 90110 Thailand
Re : K993325 Trade Name: Nitrile Examination Gloves Powderfree Regulatory Class: I Product Code: LZA Dated: September 29, 1999 Received: October 4, 1999
Dear Mr. Sood:
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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 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
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Page 2 - Mr. Sood
obligation you might have under sections 531 through 542 of obligation you may 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 markets production of mits 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 requlation 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
A. 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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Image /page/2/Picture/4 description: The image shows a stylized letter 'G' in black. A small hand icon is positioned above the letter, slightly to the left. The letter 'G' has a horizontal line cutting through its center, creating a gap in the shape.
บริษัท อินโนเวทีฟ โกรฟส์ จำกัด INNOVATIVE GLOVES Co., Ltd.
11, CHOTEVITTAYAKUL 3 ROAD, KHOHONG, HATYAI SONGKHI A 90110 TEL. (074) 428408 FAX : (074) 428409 MOBILE : 66-1-897982 I
Subject: K993325 Amendment Number : 1
Page 1 of 1
INDICATIONS FOR USE
Applicant's Name: INNOVATIVE GLOVES CO: LTD
510 (k) Number (if known): K993325
Davice Name: NITRILE LATEX EXAMINATION GLOVES, POWDERFREE
INDICATIONS FOR USE:
"A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient."
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109) ાર
Over-The -Counter-Use (Optional Format 1-2-98)
Ajer her dnd.
In Clin SPB (Division Sign-Off) Consion of Dental, Infection Control, · General Hospital "!!! › Number _
§ 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.