(184 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Patient Examination Glove, Powdered
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Vinyl Patient Examination Glove, Powdered." It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study for the device based on the given input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1998
Glormed International, Incorporated C/O Ms. Janna Tucker Official Correspondent Janna Tucker & Associates 198 Avenue de la D'Emerald Sparks, Nevada 89434
Re: K981360 Vinyl Patient Examination Glove, Powdered Trade Name: Requlatory Class: I Product Code: LYZ September 18, 1998 Dated: Received: September 22, 1998
Dear Ms. Tucker:
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. A 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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 - Ms. Tucker
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 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 requlation 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/dsmamajn.html".
Sincerely yours
Timothy A. 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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INDICATIONS FOR USE
| APPLICANT | GLORMED INTERNATIONAL. INC. |
|---|---|
| 510(K) NUMBER: | K981360 |
| DEVICE NAME: | Patient Examination Glove, Poly (Vinyl),Powdered |
A patient examination glove is a disposable device intended for medical purposes that is . I printent benefit is hand or finger to prevent contamination between patient and axaminer
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qhin 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 Use X
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 37
§ 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.