(69 days)
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Textured Powder-Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
This FDA letter is a premarket notification (510(k)) clearance for medical gloves. It does not contain the detailed information about acceptance criteria or specific studies proving device performance that you've requested.
The letter approves the device, indicating that it has been found "substantially equivalent" to legally marketed predicate devices, meaning it meets the same safety and effectiveness standards. However, it does not describe the specific testing or the acceptance criteria used to reach that determination.
Therefore, I cannot provide the information you asked for based on this document. This kind of detail would typically be found in the actual 510(k) submission, not in the clearance letter itself.
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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 with three stripes representing health, services, and people. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Ms. Belle L. Chou General Manager Shen Wei (USA) Incorporated 2845 Whipple Road Union City, California 94587
Re: K013793
Trade/Device Name: Textured Powder-Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 10, 2001 Received: November 14, 2001
Dear Ms. Chou:
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
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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal barates and equirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 CFR Part 007), labeling (21 CFR Part 820); and if requirents as set form in als quadiation 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 This letter will anow you to began mainening your of substantial equivalence of your device to 310(k) premarket nourication: "The 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 II you desire specific ad not 2019 10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and Office of Colliphanoo at (301) see contact the Office of Compliance at (301) 594-4639. advertising or you the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notification (210) It it it it is 0011).
the Act may be obtained from the Division of Small Manufacturers, International and the Act may of obtained install free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ulatowski
Timoth . 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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Anachment Two
INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
Device Name: Textured Powder-Free Latex Examination Gloves Contains 50 Micrograms or Less of Total Water Extractable Protein per Gram
Indication For Use:
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH: Office of Device Evaluation (ODE)
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev E10(k) Number .
OF.
Prescription Use Per 21CFR 801.109 Over-The Counter (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.