(77 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
OmniGrace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim
The provided document is an FDA 510(k) premarket notification letter for a medical device: "Omni Grace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim." This document confirms the substantial equivalence of the device to legally marketed predicate devices and allows it to be marketed.
However, the document does not contain any information regarding the acceptance criteria, device performance, or any studies that prove the device meets specific performance criteria. The FDA letter itself states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements and statutes and regulations administered by other Federal agencies." It primarily focuses on the regulatory clearance process based on substantial equivalence to existing devices, not on a detailed analysis of performance studies.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Results of standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval letter, not a technical report detailing performance studies.
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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 stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2 2001
Mr. William E. Patton Vice President, Regulatory Affairs OmniGrace (Thailand) Limited 641 Moo 5 Kanchanawanit Road Tambon Banpru Hatyai, Songkhla, THAILAND
Re: K012402
Trade/Device Name: Omni Grace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 27, 2001 Received: July 27, 2001
Dear Mr. Patton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Patton
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements modi that I Dri mas mass statutes and regulations administered by other Federal agencies. or the Act of ally I oderal tunates requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 CF result in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as set form in als quadis ion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 310(k) promation noticate 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 21 CFR Part 809.10 for in vitro diagnostic 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Richard
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Office of Device Evaluation Center for Devices and Radiological Health
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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
July 2001 Attachment II
OmniGrace (Thailand) Ltd. 510(k) Premarket Notification Patient Examination Glove, Latex, Powder Free, Polymer Coated with Protein Claim
INDICATIONS FOR USE STATEMENT
Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : KO12402 Device Name : OmniGrace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim
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 | OR | Over-The-Counter |
|---|---|---|
| Per 21 CFR 801.109 |
(5)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 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.