(39 days)
A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
LATEX EXAMINATION GLOVES, POWDERFREE
This document is an FDA 510(k) clearance letter for "Latex Examination Gloves Powderfree" from Innovative Gloves Company, Ltd. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states: "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..."
This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its efficacy or performance against specific, new acceptance criteria. The clearance is based on the assumption that if it's substantially equivalent to a device already on the market, it meets the inherent safety and performance standards for that product type.
Therefore, I cannot provide the requested information from this document because it is not present. The document only confirms the FDA's decision regarding market clearance of the device.
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human figures or forms, possibly representing health, well-being, and human services. The text is arranged around the circle's perimeter, with "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible.
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 Khohonq, Hatyai Songkhla 90110 Thailand
Re : K993222 Trade Name: Latex Examination Gloves Powderfree Regulatory Class: J.J. Product Code: LYY Dated: September 23, 1999 September 27, 1999 Received:
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. ಡಿ 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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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 regulation (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 one regaration oneBood, "REFFR 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
Tim Hy 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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บริษัท อินโนเวทิฟ โกรฟส์ จำกัต INNOVATIVE GLOVES Co., Ltd.
11, CHOTEVITTAYAKUL 3 ROAD, KHOHONG, HATYAI SONG KHLA 90110 TEL. (074) 428408 FAX : (074) 428409 MOBILE : 66-1-897 7821
Subject: K993222 Amendment Number : 1
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INDICATIONS FOR USE
Applicant's Name: INNOVATIVE GLOVES CO: LTD
510 (k) Number (if known): K993222
Device Name: 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) OR
Over-The -Counter-Use (Optional Format 1-2-96)
BB by Culon
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K993222
Majew L-ew twit
§ 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.