(109 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 nations and examiner.
VINYL EXAMINATION GLOVE (Pre-POWDERED)
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Powdered Vinyl Patient Examination Glove." This document is a regulatory approval letter and does not contain any information about acceptance criteria for a device, a study proving device performance, or any of the detailed aspects of a clinical study outlined in your request.
Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence and marketing approval, not on the technical performance specifications or clinical study results of the glove.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Mr. Don Morris Shanghai Poseidon Plastic Products Co. Ltd. 30798 US Highway 19N Palm Harbor, Florida 34684
K982885 Re : Powdered Vinyl Patient Examination Gloves Trade Name: Regulatory Class: I Product Code: LYZ Dated: October 21, 1998 Received: October 22, 1998
Dear Mr. Morris:
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. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory 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 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.
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Page 2 - Mr. Morris
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sia will equivalence of your device to a legally Finding of bubbeaneral squareaults in a classification for your marketed predicate actros 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 regulacionostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on comprrance as (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 at Its coll free nambor (0://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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510(k) Number (if known): K-982885
Device Name: VINYL EXAMINATION GLOVE (Pre-POWDERED)
Indications For Use:
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 nations and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concu Tence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_$\triangle$
(Optional Format 1-2-96)
Olin S. Lin
(Division Sign Division of Orion, In and General Hospital o
510(k) Number K982885
§ 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.