(78 days)
Not Found
Not Found
No
The 510(k) summary describes a surgical glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
Explanation: The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or alleviate a disease or condition.
No
Explanation: The device is a surgical glove, intended to protect a surgical wound from contamination. It does not gather information about a patient's health or disease state.
No
The device description clearly identifies the device as a "Surgical Glove," which is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function, not a diagnostic function.
- Device Description: The device is a surgical glove.
- Lack of Diagnostic Elements: The provided information does not mention any components or functions related to testing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical glove does not fit that description.
N/A
Intended Use / 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.
Product codes
KGO
Device Description
BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Glove
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
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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