(133 days)
The Medline Powder-Free Nitrile Examination Glove with Aloe is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Medline Powder-Free Nitrile Examination Glove with Aloe (Green)
The provided document is an FDA 510(k) clearance letter for the "Medline Powder-Free Nitrile Examination Glove with Aloe (Green)". This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
FDA 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not typically on extensive performance studies that would include the detailed information requested in your prompt. For devices like examination gloves, performance is usually assessed against recognized standards (e.g., ASTM standards for barrier integrity) and compared to the predicate device's performance against those same standards.
Therefore, I cannot extract the information requested from the provided text. The document primarily focuses on the regulatory clearance process and states the device's intended use.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a staff and intertwined snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matt Clausen Regulatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
Re: K081594
Trade/Device Name: Medline Powder-Free Nitrile Examination Glove with Aloe (Green) Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 2, 2008 Received: October 6, 2008
OCT 1 7 2008
Dear Mr. Clausen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Clausen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO8 | 59 4
Device Name:
Medline Powder-Free Nitrile Examination Glove with Aloe (Green)
Indications For Use:
The Medline Powder-Free Nitrile Examination Glove with Aloe is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Shule H. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081594
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use X (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.