(332 days)
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color.
The provided text {0} {1} {2} is an FDA 510(k) clearance letter for a medical device: "SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color." This document primarily grants marketing clearance based on substantial equivalence to a predicate device and outlines general regulatory obligations.
Crucially, this document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.
Therefore, I cannot provide the requested information from the given text.
The closest information available is:
- Device Name: SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color.
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Regulatory Class: I
- Product Code: KGO
- Indications For Use: "The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination."
To fulfill your request, I would need a different document, such as the full 510(k) submission, a clinical study report, or a summary of safety and effectiveness, which would detail the specific performance testing and results conducted for this glove.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 3 0 2011
Mr. Matt Clausen Regulatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
Re: K102177
Trade/Device Name: SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: KGO Dated: June 22, 2011 Received: June 23, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful' and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson, B.S., M.S., M.S., M.B.A. 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): 《102 177
Device Name:
SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color. .
Indications For Use:
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Elaine S. Marshall
(Division Sign-Uff) for Elizabeth Claveice-williams Division of Anesthesiology, General Hospital infection Control, Dental Devices
K102177 510(k) Number:
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)
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).