(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 Touch Nitrile Examination Glove, Powdered, Purple
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for "Omni Touch Nitrile Examination Glove, Powdered, Purple," which confirms the device's substantial equivalence to predicate devices and permits its marketing.
The letter and the attached "Indications For Use Statement" do not detail:
- Specific acceptance criteria for the device beyond its intended use as a medical glove.
- Any performance study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
Therefore, I cannot fulfill your request with the provided information.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles that resemble human faces or heads. The profiles are connected by flowing lines, creating a sense of unity and movement.
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 : K990698 Omni Touch Nitrile Examination Glove, Trade Name: Powdered, Purple Regulatory Class: I Product Code: LZA February 27, 1999 Dated: Received: March 3, 1999
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, 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. ਰ 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 regulation (21 CFR Part 820) and that, through periodic OS 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 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" (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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy 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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OMNIGRACE (THAILAND) LTD. 641 MOO 5 KANCHANAWANIT ROAD TAMBON BANPRU HATYAI SONGKHLA THAILAND 90250 TEL: (6674) 439 526 FAX: (6674) 210 600
February 1999 Attachment !!
OmniGrace (Thailand) Ltd. 510(k) Premarket Notification Patient Examination Glove, Nitrile, Powdered, Purple
INDICATIONS FOR USE STATEMENT
Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : Device Name : Omni Touch Nitrile Examination Glove, Powdered, Purple
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 (ODE)
| Prescription Use per 21CFR 801.109 | ||
|---|---|---|
| and and the comments of the first of the first of the first of the first of the first of the first of the first the first of the first of the first of the first the first the |
or Over-The-Counter
Shin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Dev 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.