BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES by BARRIERMED GLOVE CO.

These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens.

Device Description

Synthetic Powder-Free Surgical Gloves

AI/ML Overview

Unfortunately, based on the provided text, I cannot extract the specific information requested about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for "BarrierPlus™ Synthetic Powder-Free Surgical Gloves."

Here's why the requested information is not available in the provided text:

Nature of the Document: This is a regulatory clearance letter, not a detailed technical report or study summary. It states that the device is "substantially equivalent" to previously marketed devices, meaning it doesn't need to undergo new, extensive efficacy studies if it's demonstrated to be as safe and effective as a predicate device.
Focus of the Document: The letter confirms market clearance, lists the product code and classification, and outlines general regulatory obligations. It does not contain clinical trial data, performance metrics, or details about ground truth establishment.
Missing Information: All the specific points you asked for (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, training ground truth establishment) are typical components of a study report, which is not this document.

What the document does tell us about performance (indirectly):

Indications for Use (Page 2): "These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens."
Substantial Equivalence: The FDA's determination of "substantial equivalence" implies that the device performs comparably to a predicate device already on the market for these indications. This process relies on comparing the new device's technological characteristics and performance data (which would have been submitted in the 510(k) application but is not in this letter) to the predicate device.

To get the information you're looking for, you would need access to the full 510(k) submission (K990710) submitted by BarrierMed Glove Company, which would contain the performance data and comparisons to predicate devices. This letter only summarizes the FDA's decision based on that submission.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of a stylized caduceus with three figures representing humanity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

MAY 20 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carlo Poncipe Senior Project Manager BarrierMed Glove Company 2500 West Lake Mary Boulevard Lake Mary, Florida 32746

Re : K990710 Trade Name: BarrierPlus™ Synthetic Powder-Free Surgical Gloves Regulatory Class: I Product Code: KGO Dated: March 2, 1999 Received: March 4, 1999

Dear Mr. Poncipe:

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, labelinq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Mr. Poncipe

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA 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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE 3.0

Applicant: BarrierMed Glove Co. 510(k) Number (if known):* Device Name: Synthetic Powder-Free Surgical Gloves

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use		OR	Over-The-Counter	X
Per 21 CFR 801.109

For a new submission, do NOT fill in the 510(k) number blank (optional format1-2-96)

signature (Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number J

BarrierMed Glove Co.

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Regulation Number and Section

§ 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).