(71 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Omni Flex Nitrile Examination Glove, Powder Free
I am sorry, but I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The documents are FDA 510(k) clearance letters and an "Indications For Use Statement" for an "Omni Flex Nitrile Examination Glove, Powder-Free".
These documents do not contain any information about performance studies, acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC).
The provided text primarily focuses on:
- Regulatory Clearance: The FDA's determination that the device is "substantially equivalent" to legally marketed predicate devices.
- Product Information: Device name, applicant, and intended use (as stated in the "Indications For Use Statement").
- Regulatory Requirements: Mention of general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.
To answer your request, I would need a different type of document, such as a clinical study report, a regulatory submission summary that includes performance data, or a publication detailing the device's validation.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human figures, stacked on top of each other. The figures are abstract and appear to be facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1999
Mr. William E. Patton Vice President Regulatory Affairs OmniGrace (Thailand) Ltd. 641 Moo 5 Kanchanawanit Road Tambon Banpru, HatYai, Songkhla THAILAND 90250
Re : K990696 Omni Flex Nitrile Examination Glove, Trade Name: Powder-Free, White Requlatory Class: I Product Code: LZA Dated: February 27, 1999 March 3, 1999 Received:
Dear Mr. Patton:
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, qood 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. ਸੋ 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 requlation (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 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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Page 2 - Mr. Patton
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 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 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
Director
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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OMNIGRACE (THAILAND) LTD. 841 MOO 5 KANCHANAWANIT ROAD TAMBON BANPRU HATYAI SONGKHLA THAILAND 90250 THI: (6674) 439 526 FAX: (6674) 210 600
February 1999 Atlachment li
OmniGrace (Thailand) Ltd. 510(k) Premarket Notification Patient Examination Glove, Nitrile, Powder-Free,
INDICATIONS FOR USE STATEMENT
Applicant : OmniGrace (Thalland) Ltd. 510(k) Number : Device Name : Omni Flox Nitrile Examination Glove, Powder Free, & H : T &
Indications For Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (QDE)
Prescription Use per 21CFR 801.109___________________ or Over-The-Counter
Qlin S. Lin
(5)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) 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.