(140 days)
Textured Powder-Free Latex Exam Gloves, with Aloe Vera and Protein Claim is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Textured Powder-Free Latex Exam Gloves, with Aloe Vera and Protein Claim
This document is a 510(k) premarket notification letter from the FDA to Shen Wei (USA), Incorporated, regarding their Textured Powder-Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling claim. It is not a study report for a medical device that uses AI or reports on performance metrics that would typically apply to software or diagnostic devices.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document. This document is related to traditional medical gloves, which are physical devices and do not involve AI or complex diagnostic performance evaluation as described in your request.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with their arms raised, or a bird in flight, represented by three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 1999
Mr. Belle L. Chou Director Shen Wei (USA), Incorporated 2845 Whipple Road Union City, California 94587
Re: K983145 Textured Powder-Free Latex Examination Trade Name: Gloves with Aloe Vera and Protein Content Labeling claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY December 28, 1998 Dated: December 29, 1998 Received:
Dear Mr. Chou:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Chou
through 542 of the Act for devices under the Electronic chrough 342 or cho novelsions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your requivalence of your device to a legally marketed predicate device results in a classification for your markets and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamaip.html".
Sincerely yours
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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en Wei (USA) Inc.
2845 Whipple Road • Union City, CA 94587 • Phone (510) 429-8692 • Fax (510) 487-5347 APPLICATION FOR PREMARKET NOTIFICATION 510(K)
DEVICE CLASS: I PRODUCTION CODE: 80LYY, Textured Powder-Free Latex Exam Gloves with Aloe Vera and Protein Claim
ATTACHMENT TWO
INDICATIONS FOR USE
Shen Wei (USA) Inc. Applicant:
K 983145 510(k) Number (if known):
Textured Powder-Free Latex Exam Gloves, with Aloe Vera and Device Name: Protein Claim (50 micrograms cr ).
Indications For Use:
Textured Powder-Free Latex Exam Gloves, with Aloe Vera and Protein Claim is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
This device is not intended to be used as a chemical barrier.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluaton (ODE)
Qlin S. Lin
(Division Sign-Off Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X
(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.