(30 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
The provided text is a 510(k) premarket notification for "Ultra Touch Powdered Latex Examination Gloves, with Protein Labeling Claim (120 Micrograms or Less)". This document is a regulatory approval letter from the FDA, and it does not contain information about acceptance criteria or a study proving device performance.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would typically be detailed for a novel device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC comparative effectiveness studies from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 6 2002
Ms. Chua Choon Chuan Managing Director AR Alliance Healthcare Sdn. Bhd. 8, Lorong Industri 11, Kawasan Perindustrian Bukit Panchor, Nibong Tebal, Pulau Pinang, MALAYSIA
Re: K020359
K020339
Trade/Device Name: Ultra Touch Powdered Latex Examination Gloves, with Protein Labeling Claim ( 120 Micrograms or Less ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class:I Product Code: LYY Dated: February 1, 2002 Received: February 4, 2002
Dear Ms. Chuan:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becates as a read 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to do roves and novel Act (Act) that do not require approval of a premarket the Federal I ood, Drug, and Commons, therefore, market the device, subject to the general approval application (1 Million . The general controls provisions of the Act include controls provisions of the ristration, 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 IT your device is classified (See as additional controls. Existing major regulations affecting (I MA), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can or found in firsher announcements concerning your device in the Federal Register.
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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 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,
Timothy Ulatowski Director Division of Dental, Infection Control and General Hospital 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. email : arhealthcare@po.jaring.my Tel : (04)-5937616 Fax : (04)-5932262 Our Ref : CCC/100102/04
Page : 1/1 Date : 10/01/2002
ATTACHMENT 2 :
INDICATION FOR USE
Applicant : AR ALLIANCE HEALTHCARE SDN. BHD.
510(k) Number (if known) :
Device Name : POWDERED LATEX EXAMINATION GLOVES WiTH
Trade Name : (1) ULTRA TOUCH (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 UsePer 21 CFR 801.109 | OR | Over-The-Counter | ||
|---|---|---|---|---|
| Division Sign-Off | ||||
| Division of Dental, Infection Control, | ||||
ੀ General Hospital Dr. Frid Number . " Je 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.