(38 days)
The medical gloves are worn on the hands of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Nitrile Powder Free Patient Examination Gloves
This document is a 510(k) clearance letter from the FDA for Nitrile Powder Free Patient Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance in the context of medical devices that typically involve AI or complex algorithms.
The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This determination is based on the device meeting general controls provisions and Good Manufacturing Practice (GMP) regulations, not on specific performance metrics from a clinical study as would be described for an AI-powered diagnostic device.
Therefore, I cannot provide the requested information from the provided document.
{0}------------------------------------------------
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Mr. Keidy Gu Vice President JDA International, Inc. 2919 E. Philadelphia Street Ontario, California 91761
Re : K993247 Nitrile Powder Free Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LZA September 21, 1999 Dated: Received: September 28, 1999
Dear Mr. Gu:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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
{1}------------------------------------------------
Page 2 - Mr. Gu
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener 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/dsmamain.html".
Sincerely yours,
Watrous
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
JDA INTERNATIONA, INC.
2919 E. PHILADELPHIA STREET ONTARIO, CA 91761 TEL: 909-923-8318 FAX: 909-673-0660
ATTACHMENT I
Indication For Use Statement
510K number ( if known ):
Device Name: Nitrile Powder Free Patient Examination Gloves
Indications for Use:
The medical gloves are worn on the hands of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
JDA International, Inc.
Keidy Ly
Keidy Gu
( Please Do Not Write Below This Line-Continue On Another Page If Needed.)
Concurrence of CDRH, Office of Device Evaluation ( ODE )
Prescription Use
Or Over-The-Counter Use
( Optional Format 1-2-96 )
Clins S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 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.