(71 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powdered Synthetic Vinyl Patient Examination Gloves, Yellow
The provided text is a 510(k) premarket notification letter from the FDA to Long First (Xiamen) Plastics Company Limited regarding their "Brothers Powered Synthetic Vinyl Patient Examination Gloves Yellow." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a regulatory approval document stating that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other administrative aspects, but not performance testing details.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 7 2003
Long First (Xiamen) Plastics Company Limited C/O Ms Stone Chen President Kaohsiung Brother Products Company 23 Kooshan 3rd Road Kaosiung Taiwan, R.O.C.
Re: K032323
Trade/Device Name: Brothers Powered Synthetic Vinyl Patient Examination Gloves Yellow Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 24, 2003 Received: July 29, 2003
Dear Mr. Chen:
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. Chen
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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Clus L
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows a logo with a stylized letter 'B' inside a square. The 'B' is formed by two horizontally stacked shapes, each resembling a modified letter 'D' or a half-oval with a slanted, angular edge on the left side. The logo is filled with a solid black color, contrasting with the white background of the square.
KAOHSIUNG BROTHERS PRODUCTS CORPORATION
Office : 23, Kooshan 3rd Road, Kaohsiung, Taiwan, R.O.C. :886-7-56122015 Tel : 886-7-56122067 Fax E-Mai I : sales@tehloong.com.tw
Chris S. Ulm
ATTACHMENT B
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number
INDICATION FOR USE STATEMENT
K032323 510K Number (if known): ______________________________________________________________________________________________________________________________________________________ Device Name: Powdered Synthetic Vinyl Patient Examination Gloves, Yellow
Indications For Use:
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
LONG FIRST ( XIAMEN ) PLASTICS CO., LTD.
stone coen
STONE CHEN
( PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED )
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
Over-The-Counter Use
( Per 21 CFR 801.109 )
(Optional Format 1-2-96)
§ 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.