(253 days)
The PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.
PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22mm Model 2: 0.30mm
This document is a 510(k) clearance letter from the FDA for surgical gloves and an "Indications for Use" statement. It does not contain any information about acceptance criteria or a study proving that a device meets those criteria.
The prompt asks for details related to acceptance criteria, device performance, study design (sample size, data provenance, ground truth establishment, MRMC studies, standalone studies), and expert qualifications, which are typical for studies supporting the effectiveness or substantial equivalence of diagnostic or AI-powered devices.
Since the provided text is for surgical gloves, which are general hospital devices and not diagnostic or AI-powered, these detailed study requirements are not applicable to the documentation provided. The 510(k) process for surgical gloves focuses on demonstrating substantial equivalence to a predicate device, primarily through material properties, manufacturing standards, and performance characteristics like barrier integrity, rather than complex clinical studies involving ground truth and expert consensus for interpretation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
Emerson & Co. S.r.1. Stefano Costigliolo Executive Director Piazza Della Vittoria, 10 16121 Genoa - Italy
Re: K151228
Trade/Device Name: Proguard Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22mm Model 2: 0.30mm Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 3, 2015 Received: December 21, 2015
Dear Stefano Costigliolo:
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.
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
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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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/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 Industry and Consumer Education 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151228
Device Name Device Name Model 1: 0.22mm Model 2: 0.30mm
Indications for Use (Describe)
Indications for Use (Describe)
The PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).