(98 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Not Found
This document is a 510(k) clearance letter from the FDA for medical gloves, and it does not contain the type of information requested in the prompt. The request asks for details about a study and acceptance criteria for a device, which typically refers to a diagnostic or therapeutic device whose performance is measured against specific metrics.
This document, however, is solely about the regulatory clearance of "NITRI GRIP Powdered Nitrile Examination Gloves" and confirms their substantial equivalence to predicate devices, thus allowing them to be marketed. It does not include:
- A table of acceptance criteria and device performance.
- Details about a test set (sample size, data provenance, ground truth experts, adjudication).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on a training set or how ground truth for training was established.
The "Indications for Use" section (page 2) simply states the purpose of the gloves, which is to prevent contamination between healthcare personnel and patients, not a performance metric for which a study with acceptance criteria would be conducted in the context of the prompt's questions.
Therefore, I cannot fulfill the request based on the provided document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "U.S. Department of Health & Human Services - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 8 2002
Mr. Chua Choon Chuan 8, Lorong Industri 11, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Pulau Pinang, MALAYSIA
Re: K022572
Trade/Device Name: NITRI GRIP Powdered Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: April 10, 2002 Received: October 9, 2002
Dear Mr. Chuan:
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. Chaun
Please be advised that FDA's issuance of a substantíal equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 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 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,
Susan Runne
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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AR Alliance Healthcare Sdn.Bhd.
8, Lorong Industri 11, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Tel : (04)-5937616 Fax : (04)-5932262 email : arhealthcare@po.jaring.my Our Ref : CCC/300702/04 Date : 30/03/2002 Page :1/1
ATTACHMENT 2 :
KA22572
INDICATION FOR USE
Applicant : AR ALLIANCE HEALTHCARE SDN. BHD.
510(k) Number (if known) :
Device Name : POWDERED NITRILE EXAMINATION GLOVES.
Trade Name : (1) NITRI GRIP (2) Other clients private labeling
Indication For Use :
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Per 21 CFR 801.109 sion Sign-Olf)
ion of Anesthesiology, General Hospital, tion Control, Dental 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.