(30 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.
Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves
This is a 510(k) clearance letter for disposable examination gloves. This type of device does not typically involve the kind of "acceptance criteria" and "study" that would be performed for AI/ML-powered medical devices as your questions imply. The FDA clearance process for these devices primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to performance metrics against specific criteria for an algorithm.
Therefore, I cannot answer the questions directly as they are not applicable to the provided document. The document describes a traditional medical device (disposable gloves) and its regulatory clearance, not an AI/ML device.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 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 an abstract image of an eagle.
OCT 2 7 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Huan Chung Li Vice President Shinemound Enterprise Inc. 17A Sterling Road North Billerica, Massachusetts 01862
Re: K993231
Trade Name: Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves Requlatory Class: I Product Code: LYZ Dated: September 23, 1999 Received: September 27, 1999
Dear Mr. Li:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class TTT (Premarket Approval), 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 895. ಗಿ 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 regulation 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
{1}------------------------------------------------
Page 2 - Mr. Li
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 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,
Tim A. Wlatowski
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}------------------------------------------------
Attachment G
INDICATION FOR USE
Huan-Chung Li, Shinemound Enterprise, Inc. Applicant: 510K Number(if known): 510K Number(if known). Indication For Use:
A patient examination gloves is a disposabledevice intended for medical purpose that is
t and A patient examination gloves is a disposabledovice involver.
worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(PI.E.ASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Over-The-Counter Use
Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96)
- For a new submission, do NOT fill in the 510(K) number blank
OR
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital I .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.