(210 days)
BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Not Found
This document is a 510(k) clearance letter for the BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove, not a study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way a clinical study report would.
However, based on the information provided, I can infer some aspects and highlight what is missing:
Missing Information:
- Acceptance Criteria/Reported Performance: The document provides the device name and its intended use, but it does not list specific performance metrics or acceptance criteria (e.g., tensile strength, puncture resistance, barrier integrity, biocompatibility data, etc.) that would typically be required for a surgical glove. It also does not report any device performance against such criteria.
- Study Details: There is no mention of any specific study that proves the device meets acceptance criteria. The 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical efficacy or performance studies in all cases. The letter indicates that the FDA "reviewed your Section 510(k) premarket notification" and deemed the device substantially equivalent. This suggests that the submission included data (likely non-clinical, mechanical, and perhaps biocompatibility testing) to support this equivalence, but those specific data points and the studies that generated them are not detailed here.
Inferences based on the document:
- Device Type: Surgical Glove (Product Code: KGO, Regulation Number: 21 CFR 878.4460)
- Intended Use: "BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination."
Summary of Missing and Inferable Information:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. Surgical gloves typically have acceptance criteria related to:
- Barrier integrity (e.g., AQL for pinholes)
- Physical properties (e.g., tensile strength, elongation, force at break)
- Dimensions (e.g., length, palm width, thickness)
- Biocompatibility (e.g., cytotoxicity, irritation, sensitization)
- Powder content (since it's powder-free)
- Sterility (if applicable)
The document only states that the device was found substantially equivalent to a predicate device, implying it met certain undisclosed performance standards.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided. Any testing supporting the 510(k) submission would have involved sample sizes for specific tests (e.g., AQL testing for pinholes, mechanical property testing), but these details are absent.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This is not applicable to a submission for a surgical glove. "Ground truth" and expert reviews are typically associated with diagnostic or image-analysis AI devices, not physical medical devices like gloves. Performance data for gloves is obtained through objective laboratory testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is not applicable for the same reasons as point 3.
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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: This is not applicable as this is a physical medical device (surgical glove), not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable as this is a physical medical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): This is not applicable for a surgical glove. Performance is measured against established international standards (e.g., ASTM, ISO) for glove properties.
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The sample size for the training set: This is not applicable as there is no "training set" for a physical medical device. This term applies to machine learning/AI models.
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How the ground truth for the training set was established: This is not applicable for the same reasons as point 8.
In summary, this document is an FDA clearance letter based on substantial equivalence, not a detailed technical report of device performance studies. The types of questions asked (e.g., ground truth, experts, training sets, MRMC studies) are characteristic of AI/diagnostic device evaluations, which do not apply to the BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black lines. Encircling the profiles is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2006
Mr. Victor J. Ragucci Chairman & CEO BarrierMed Glove Company 155 Technology Park Lake Mary, Florida 32746
Re: K053406
Trade/Device Name: BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: June 17, 2006 Received: June 21, 2006
Dear Mr. Ragucci:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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 of the Act or any Federal statutes and regulations administered by other Federal aqencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing proctice 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sustie H. Michie Davis.
Chíu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement: 3.0
INDICATIONS FOR USE
| Applicant: | BarrierMed Glove Co.® |
|---|---|
| ------------ | ----------------------- |
510(k) Number (if known): *___________________________________________________________________________________________________________________________________________________
Device Name: BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove
Indications For Use:
BarrierPlus® Gold Powder-free Synthetic Polyisoprene 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 _X (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)
Shiela A. Mccarthy, MD
nesthesiology, General Hospital, ontrol, Dental Devices
Number 143466
- For a new submission, do NOT fill in the 510(k) number.
CONFIDENTIAL
BarrierMed Glove Co.
§ 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).