(381 days)
Our surgeon's gloves are a device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Gantex Model NSG-75PF Powder Free Surgeon Glove
The provided text is a 510(k) clearance letter from the FDA for a surgeon's glove, not a document describing an AI/ML medical device study. Therefore, most of the requested information about acceptance criteria, study design, ground truth, and expert involvement for an AI medical device cannot be extracted from this document.
However, I can extract the following relevant and limited information:
Device: Gantex Model NSG-75PF Powder Free Surgeon Glove
Regulatory Class: I
Product Code: KGO
Indications For Use: Our surgeon's gloves are a device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Regarding the requested information, here's what can be inferred or stated as "not applicable":
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics typical for AI devices. The clearance is based on "substantial equivalence" to a predicate device. For gloves, this typically involves material properties (dimensions, tensile strength, elongation), barrier integrity (water leak test), and biocompatibility.
- Reported Device Performance: Not detailed in this letter. The letter affirms "substantial equivalence," implying the device met the performance characteristics expected of general surgeon gloves.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document is not about an AI/ML study. Performance data for physical devices like gloves would be generated from laboratory testing and quality control, not "test sets" in the AI sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the AI sense is not relevant for this device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for a surgeon's glove would be its physical and chemical properties meeting established standards (e.g., ASTM standards for medical gloves) and maintaining barrier integrity, which are verifiable through standard laboratory tests, not expert consensus in the diagnostic sense.
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The sample size for the training set:
- Not applicable. This pertains to an AI model, not a physical device like a glove.
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How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ross Litton ·President American Pro Latex, Incorporated _ JUL 1 4 1997 1690 N. Elston 60622 Chicago, Illinois
K962539 Re : Gantex Model NSG-75PF Powder Free Surgeon Trade Name: Glove Requlatory Class: I Product Code: KGO Dated: April 17, 1997 Received: May 14, 1997
Dear Mr. Litton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
not affect any obligation you might have under sections 531
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Page 2 - Mr. Litton
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification: The FDA war 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene office of compiland, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Claturd
Uhy A. Ulatowski Tim Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Page of
510(k) Number (if known): 长962539
Gantex Model NSG-75PF Powder Free Surgeon Glove Device Name: Indications For Use:
Our surgeon's gloves are a device intended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH/Office of Devise Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices K962539
Prescription Use __
OR
Over-The-Counter Use X
(Per 21 CFR 801.109)
(Optiona! Format 1-2-96)
§ 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).