(47 days)
Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove, which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free
This document is a 510(k) clearance letter from the FDA for a medical device, specifically examination gloves. This type of document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as these are typically found in the 510(k) submission itself, not the clearance letter.
Therefore, I cannot provide the requested information from the provided text. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed subject to general controls.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 8 2002
Mr. S. N. Hari Production Manager Industrial Clothing Limited Prime Polymers Division No. 481 A. Prince of Whales Avenue, Colombo 14, SRI LANKA
Re: K022781
Trade/Device Name: Midas Touch™ Purple Nitrile Examination Gloves-Polymer Coated, Powder Free Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 6, 2002 Received: September 18, 2002
Dear Mr. Hari:
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 anproval 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. Hari
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 (OS) 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 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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Industrial Clothings Limited
(Prime Polymers Division) 510(k) submission for Purple Nitrile Examination Glove – Polymer coated. Powder free
:
3.0 Indications for use
Applicant
: Industrial Clothings Ltd. (Prime Polymers Division)
510(k) number Device name
K022781
: Midas Touch™ Purple Nitrile Examination Gloves – Polymer coated, Powder free
Indications for use:
Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove, which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Ro. Clutts
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number. L980105
§ 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.