(39 days)
A 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.
Patient examination glove VINYL - POWDER FREE
This document is a 510(k) premarket notification approval letter for "Vinyl Examination Gloves Powder Free." It is not a study report for a medical device that uses acceptance criteria based on performance metrics that would be evaluated by experts or AI.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these concepts are not applicable to the content of this regulatory approval.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Sun Flowers Gloves Company, Ltd. C/O David Hu, Ph.D. President HTI Trading Group 3423 Investment Boulevard, Suite 12 Hayward, California 94545
K974777 Re: Vinyl Examination Gloves Powder Free Trade Name: Requlatory Class: I Product Code: LYZ December 17, 1997 Dated: Received: December 22, 1997
Dear Dr. Hu:
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, good manufacturing practice, flabeling, and woma 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 regulations 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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
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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 requlations.
This letter will allow you to beqin 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) 594-4618. 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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| 01-14-1998 10:28AM | FROM | TO | 13014803002 |
|---|---|---|---|
| 510(k) Number (if known) | K974777 | Page ___ of ___ | |
| Device Name: | Patient examination glove VINYL - POWDER FREE | ||
| Indications For Use: | |||
| A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's hand orfinger 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) | |||
| (Division Sign-Off) | |||
| Division of Dental, Infection Control,and General Hospital Devices | |||
| 510(k) Number | K974777 | ||
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use 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.