(35 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Disposable Powder Free Vinyl Patient Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for "Disposable Powder Free Vinyl Patient Examination Gloves." It is not a study report or clinical trial document for a diagnostic AI device. Therefore, it does not contain the information required to answer your request regarding acceptance criteria, study details, ground truth, or sample sizes related to an AI device.
The document discusses the substantial equivalence of the gloves to previously marketed predicate devices under the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
To answer your questions, I would need a document that describes a study performed on a medical AI device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three abstract human figures, represented by flowing lines, positioned to suggest movement or progress.
Public Health Service
SEP 1 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Brilliance Plastic Company Limited C/O Mr. Huan Chung Li Shinemound Enterprise, Incorporated 17A Sterling Road North Billerica, Massachusetts 01862
Re: K012711
Trade/Device Name: Disposable Powder Free Vinyl Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: June 8, 2001 Received: August 14, 2001
Dear Mr. Li:
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.
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.
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Page 2 - Mr. Li
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with as and manufacturing (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT at 007), as ality systems (QS) regulation (21 CFR Part 820); and if requirents as sectorial in advanced the control provisions (section 531-542 of the Act, 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begal mading of substantial equivalence of your device to a premarket notification. - In 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 If you dosire specific and for in vitro diagnostic devices), please contact the Office of and additionally (30) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. advertibing or your the regulation entitled, "Misbranding by reference to premarket I tion, predoc note the regar. 97). Other general information on your responsibilities under the notification (21011-06797). States grown
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,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
Feng Lian Fa, Shijiazhuang Brilliance Plastic Co., LTD Applicant:
K012711 510K Number(if known): 米
Device Name: Powder Free Vinyl Patient Examination Gloves Indication For Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Sincerely yours,
Image /page/2/Picture/7 description: The image contains Chinese characters and the English words "Feng Lian Fa". The Chinese characters are written in black ink and appear to be a signature or a title. The English words are printed below the Chinese characters in a smaller font size. The image is a close-up shot of the text.
President
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use Per 21 CFR 801.109 OR
Over-The Counter Use
(Optional Format 1-2-96)
*For a new submission, do NOT fill in the 510(K) number blank
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 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.