(126 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.
VitalCare Exam Gloves (Latex), Paude
I am sorry, but based on the provided document, I cannot answer the question regarding acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for VitalCare Latex Exam Gloves, Powdered, and it primarily focuses on the regulatory clearance process and the device's substantial equivalence to legally marketed predicate devices.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study, including sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
The document confirms the device's classification and allows its marketing, but it does not provide the detailed study results or acceptance criteria you are asking for.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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
DEC 2 1 1998
Ms. Ginger Talley VitalCare Group, Incorporated 15800 N.W. 13th Avenue Miami, Florida 33169
K982901 Re : VitalCare Latex Exam Gloves, Powdered Trade Name: Requlatory Class: I Product Code: LYY October 15, 1998 Dated: Received: October 21, 1998
Dear Ms. Talley:
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 reqistration, 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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.
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Page 2 - Ms. Talley
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 diaqnostic 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 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,
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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P. 2 No . 0861
INDICATIONS FOR USE
Applicant: VitalCare Group, Inc. 15800 N.W. 13th Avenue Miami, FL 33169
510(k) Number (if Known): K982901
Device Name: VitalCare Exam Gloves (Latex) , Paude
Indications 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.
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use _ or Over-The-Counter $\boxed{ \checkmark }$ _
I
SBarrito for Chiu Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K982901
§ 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.