(331 days)
"An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner." In addition, the glove is suitable for oncology use.
Powder-Free Natural Rubber Latex Examination Glove (Tested For Use With Chemotherapy Drugs) With Protein Content Labeling Claim (50 micrograms or less)
This document is a marketing approval letter for a medical device (a glove), not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study design, and performance metrics cannot be extracted.
The document states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the device meets the regulatory requirements for marketing, but it does not provide specific performance criteria or the results of a scientific study as you would expect for evaluating an AI medical device.
Specifically, none of the requested information (points 1-9) can be found in the provided text. The document pertains to regulatory approval based on substantial equivalence, not a clinical or technical performance study.
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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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2000
Mr. Bradley L. Pugh Vice President, Scientific Affairs London International Group, LLC US Manufacturing P.O. Box 8308 Dothan, Alabama 36304
Re: K991677 Powder-Free Natural Rubber Latex Examination Trade Name: Glove (Tested for Use with Chemotheraphy Drugs) with Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY Dated: January 13, 2000 January 19, 2000 Received:
Dear Mr. Pugh:
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, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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Page 2 - Mr. Pugh
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) 594-4690. 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 ene regaration of therion" (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.fdaf.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX II
Indications For Use
Page 1 of 1
| Applicant: | London International Group (Regent Medical Division) |
|---|---|
| 510(K) Number (if known): | K 991677 |
| Device Name: | Powder-Free Natural Rubber Latex Examination Glove (Tested For Use WithChemotherapy Drugs) With Protein Content Labeling Claim (50 micrograms or less) |
Indications For Use:
"An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner." In addition, the glove is suitable for oncology use.
(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 | K991627 |
|---|---|
| --------------- | --------- |
| 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.