(78 days)
BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Glove
The provided text is a 510(k) premarket notification letter from the FDA regarding a surgical glove, not a study report for a diagnostic device or AI algorithm. Therefore, it does not contain the information required to answer your prompt. The document is an approval letter for a medical device (surgical gloves) and discusses regulatory compliance rather than performance studies or acceptance criteria in the context of device accuracy or effectiveness for diagnostic purposes.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about the ground truth.
- Information on expert adjudication, MRMC studies, or standalone algorithm performance.
- Details about training sets or how ground truth for training was established.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
DEC 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Victor J. Ragucci Chairman & CEO BarrierMed Glove Company 155 Technology Park Lake Mary, Florida 32746
Re: K052772
Trade/Device Name: BarrierPlus Gold Prtho Powder-Free Synthetic Polyisoprene Orthopedic Surgical Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 6, 2005 Received: December 8, 2005
Dear Mr. Ragucci:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have revious your because some 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 interstate conments, or to thay been reclassified in accordance with the provisions of Amendinents, or to de rouses and Cosmetic Act (Act) that do not require approval of a premarket the Federal F ood, Drag, and Commay, therefore, market the device, subject to the general approvin application (1 he Act. The general controls provisions of the Act include controls provisions of the stration, 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 II your device is classified (See as 10) in a controls. Existing major regulations affecting (1 MA), it may oe subject to Bach adataf Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Sous nouncements concerning your device in the Federal Register.
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Page 2 - Mr. Ragucci
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 mean that in DA mas made a avernand regulations administered by other Federal agencies. of the Act of ally I ederal button and squirements, including, but not limited to: registration r ou intist comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF Rev or 7), and 1007), and ity systems (QS) regulation (21 CFR Part 820); and if requirences as bet form nroduct 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) Frins feter will and in J . The FDA finding of substantial equivalence of your device to a premarket notified.com. - The PDF 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), If you desire specific au rios for Jourse at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other general Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Senyte Y. Michael Davis.
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
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1.0 Indications for Use Statement:
INDICATIONS FOR USE
Applicant: BarrierMed Glove Co.®
510(k) Number (if known): *
Device Name: BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Glove
Indications For Use:
BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula T. Murphy D 12/14/65
i
Massachusetts General Hospital,
Lab Control, Central Devices
T fill in the 510(k) number.
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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).