(64 days)
A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
SUPERGLOVES Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.
The document is an FDA 510(k) clearance letter for "SUPERGLOVES® Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)". It confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The letter mentions general controls provisions and regulatory requirements but does not include any performance study data or detailed acceptance criteria.
The "Indications for Use" section defines what the gloves are for, but it does not contain any performance metrics or criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 24 1998
Mr. Tim Thai Vice President Mexpo International Incorporated 2671 McCone Avenue Hayward, California 94545
Re : K974782 SUPERGLOVES® Powder Free Latex Examination Trade Name: Gloves with Protein Labeling Claim (50 Micrograms or less) Requlatory Class: ] Product Code: LYY Dated: December 18, 1997 December 22, 1997 Received:
Dear Mr. Thai:
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 Requlations, Title 21; Parts 800 to 895. mA .......................................................................................................................... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 requlation 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
Image /page/0/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
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Page 2 - Mr. Thai
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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 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 regulation (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 she 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,
Patricia Cuesnitoffor
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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
Applicant: Mexpo International Inc.
510(k) Number (if known): _
LATEX EXAMINATION GLOVES, W Device Name: __SUPERGLOVES_POWDER Indications For Use:
A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient. -----
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Qhia Si lin
(Division S 510(k) Num
Prescription Use ... ................. OR Per 21 CFR 801.109
Over-The-Counter
(Optional Format 1-2-96)
- For a new submission, do NOT fill in the 510(k) number blank.
§ 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.