(58 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the exar iner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Non-Sterile Vinyl Examination Gloves
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets any acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Vinyl Exam Gloves, Powder-Free," indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.
The information provided only discusses:
- The FDA's decision to allow the marketing of the device.
- The regulatory class and product code.
- General controls provisions.
- Directions for further information or questions regarding labeling, promotion, and advertising.
- The "Indications For Use" statement for the gloves.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2000
Shanghai Champion Plastic Products Company, Limited c/o Ms. Janna P. Tucker Official Correspondent for Shanghai Champion Plastic Products Company, Limited Tucker and Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550
Re: K994136 Vinyl Exam Gloves, Powder-Free Trade Name: Regulatory Class: I Product Code: LYZ Dated: November 27, 1999 December 7, 1999 Received:
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 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 requlatory 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
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Page 2 - Ms. Tucker
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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" (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
Timothy A. Ula 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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EXHIBIT B
Page_ ર્ભ
510(k) Number (if known): K 994136
Powder-Free Non-Sterile Vinyl Examination Gloves Devica Name:_
Indications For Use.
A patient examination glove is a disposable device intended for medical purposes that is worn on the exar iner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (F HEEDED)
Concu tence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_**_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_$\boxed{X}$
(Optional Format 1-2-96)
Chin S. Lin
(Division Sign-Off) Division of Dental, Infe and General Hosp 510(k) Number
EXHIBIT B
Page 2 of 50
§ 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.