(17 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 patient and examiner.
Powder Free Sterile Synthetic Vinyl Examination Gloves
I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Synthetic Vinyl Patient Examination Gloves" and pertains to regulatory approval, not device performance studies or acceptance criteria. Therefore, I cannot extract the table of acceptance criteria, device performance, or details about any study as this information is not present in the given text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2001
Mr. Antonio L. Giaccio Mr. Anconio Di Quality Systems & Regulatory Affairs Cypress Medical Products 1202 South Route 31 McHenry,, Illinois 60050
K012282 Re : Sterile Powder Free Synthetic Trade/Device Name: Vinyl Patient Examination Gloves Requlation Number: 880.6250 Requlatory Class: I Product Code: LYZ July 20, 2001 Dated: Received: July 20, 2001
Dear Mr. Giacco:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the device ially 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 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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation may result in regulatory
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Page 2 - Mr. Giaccio
In addition, FDA may publish further announcements action. action. In address. I in the Federal Register. Please note: this concerning your device in snotification submission does not affect response to your promarked not reading to through 542 of the any obrigacion you magics Electronic Product Radiation Control provisions, or other Federal laws or regulations._
This letter will allow you to begin marketing your device as Into lecce will allows and the notification. The FDA finding of described in your alence of your device to a legally marketed substancial equivalence oil a classification for your device and prealeded at rour device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in xItro regulation (21 erk rare over and addition of Compliance at (301) Additionally, for questions on the promotion and 594-4692. 594-4622. Additionally, for queborome of the Office of Complance advertifing or your device) promote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97) . MISDIanding by reference on your responsibilities under the Act may Ocher general information of Small Manufacturers Assistance at be obcained from the 2002) 638-2041 or (301) 443-6597 or at its its correret address "http://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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Applicant: Cypress Medical Products, LP 510 (k) Number (if known): KO/ 2282 Device Name: Powder Free Sterile Synthetic Vinyl Examination Gloves
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 patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
Qian S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _
§ 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.