(92 days)
The FlexGard® Cut-Resistant Glove Liners are single use glove liners intended to help with protection against cuts when used with an inner and outer surgical glove. The glove liner must be worn between two surgical gloves.
The FlexGard Cut Resistant Glove Liners provide an optional method of providing cut resistance to surgical gloves. The FlexGard Cut Resistant Glove Liners are applied between layers of surgical gloves. The FlexGard Cut Resistant Glove Liners are placed over a surgical glove and subsequently covered by a surgical glove.
The FlexGard Cut Resistant Glove Liners are ambidextrous, there is no left or right handed Glove Liner variations.
The FlexGard Cut Resistant Glove Liners are provided to the user terminally sterilized by a validated ethylene oxide process. The FlexGard Cut Resistant Glove Liners are labeled for single use.
The FlexGard Cut Resistant Glove Liners provide protection against cuts and slashes. The FlexGard Cut Resistant Glove Liners are not puncture resistant or cut proof.
The provided document is a 510(k) Premarket Notification for the FlexGard® Cut-Resistant Glove Liners. It details the device's characteristics, intended use, and comparative analysis with a predicate device.
However, the request asks for information related to a study that proves a device meets acceptance criteria, specifically focusing on AI/machine learning models in medical imaging, as indicated by questions 2-9 (sample size for test/training sets, data provenance, expert ground truth, MRMC study, standalone performance, etc.).
The FlexGard® Cut-Resistant Glove Liners are a physical medical device (glove liners) and not an AI/machine learning software device. Therefore, the detailed questions about AI model testing (like the number of experts, adjudication methods, MRMC studies, training/test set ground truth establishment, or standalone algorithm performance) are not applicable to the information provided in this 510(k) submission.
The document describes non-clinical performance tests for a physical product, addressing aspects like cut protection, sterility, biocompatibility, and shelf life.
Here's the information extracted that is applicable to the prompt, focusing on the acceptance criteria and the study (non-clinical testing) that proves the device meets these criteria:
Acceptance Criteria and Reported Device Performance
The document presents a table summarizing non-clinical performance tests conducted to demonstrate the device met its acceptance criteria.
Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cut Protection | Meet requirements for ANSI/ISEA 105-2011, Level 2 cut resistance. | Pass |
| Sterility | Sterility assurance level (SAL) of 10-6. | Pass |
| Sterile Barrier Package Integrity | The sterile barrier Tyvek pouch must have a seal strength $\geq$ 1 lbf and not leak. | Pass |
| Biocompatibility (Cytotoxicity) | Cytotoxicity passes for a Grade of $\leq$ 2. | Pass (Grade = 1) |
| Biocompatibility (Sensitization) | Sensitization passes for a Grade = 0. | Pass (Grade = 0) |
| Biocompatibility (Irritation) | Irritation passes for a Primary Irritation Index $\leq$ 0.4. | Pass (Primary Irritation Index = 0) |
| Shelf Life (2 years) | Cut Protection: Meet requirements for ANSI/ISEA 105-2011, Level 2 cut resistance. Sterile Barrier Package Integrity: The sterile barrier Tyvek pouch must have a seal strength $\geq$ 1 lbf and not leak. | Pass |
Inapplicability of AI/ML Specific Questions:
The following questions regarding AI/ML study design are not applicable to this submission for a physical medical device:
- Sample sized used for the test set and the data provenance: Not applicable. This is a physical product, not an AI model. Testing involved physical samples of gloves for performance (e.g., cut resistance, sterility, biocompatibility).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by standardized test methods (e.g., ASTM standards for cut resistance, ISO standards for sterility, biocompatibility).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept applies to human reader consensus for AI model ground truth, not physical device testing.
- 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. MRMC studies are for evaluating clinical performance of AI systems in diagnostic tasks, not for physical devices like glove liners.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical devices, ground truth is based on physical measurements and standardized test results (e.g., force required to cut, microbial presence, biocompatibility assays). These are derived from established scientific and engineering principles, not expert consensus in image interpretation.
- The sample size for the training set: Not applicable. This refers to training data for AI models.
- How the ground truth for the training set was established: Not applicable. This refers to ground truth for AI models.
In summary, the provided document outlines the non-clinical testing and acceptance criteria for a physical medical device (cut-resistant glove liners) and successfully demonstrates that the device passes those criteria. The questions posed in the prompt are designed for the evaluation of AI/Machine Learning medical devices and are therefore not relevant to this specific premarket notification.
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June 27, 2019
LDI Corporation % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K190782
Trade/Device Name: FlexGard Cut-Resistant Glove Liners Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: March 22, 2019 Received: March 27, 2019
Dear Gary Syring:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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 agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190782
Device Name FlexGard® Cut-Resistant Glove Liners
Indications for Use (Describe)
The FlexGard® Cut-Resistant Glove Liners are single use glove liners intended to help with protection against cuts when used with an inner and outer surgical glove. The glove liner must be worn between two surgical gloves.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for LDI Environmental and Safety Solutions. The letters "LDI" are in a large, bold, blue font. Below the letters is the text "ENVIRONMENTAL AND SAFETY SOLUTIONS" in a smaller font. To the right of the letters is a green recycling symbol with a red cross in the center.
510(k) Summary - K190782
This summary is provided to support the 510(k) pre-market notification for the FlexGard® Cut-Resistant FlexGard Liners, as accessories to surgical gloves.
| Company Name: | LDI Corporation3560 Lafayette RoadBuilding 2, Suite CPortsmouth, NH 03801 |
|---|---|
| Company Contact: | Lou LaMarca, CEOLDI CorporationPhone: 603-436-0077 |
| Date Summary Prepared: | June 20, 2019 |
| Trade Name: | FlexGard® Cut-Resistant Glove Liners |
| Common Name: | Surgical Glove Accessory, Glove Liners |
| Classification Name: | Surgeon's Glove (Accessory: Cut Resistant Glove Liners)21 CFR 878.4460 Surgical Glove (Accessory), Class IProduct Code: KGOClass I |
| Predicate Devices: | K160974Gammex® Cut Resistant Glove LinerAnsell Healthcare Products LLC |
Product Description
The FlexGard Cut Resistant Glove Liners provide an optional method of providing cut resistance to surgical gloves. The FlexGard Cut Resistant Glove Liners are applied between layers of surgical gloves. The FlexGard Cut Resistant Glove Liners are placed over a surgical glove and subsequently covered by a surgical glove.
The FlexGard Cut Resistant Glove Liners are ambidextrous, there is no left or right handed Glove Liner variations.
The FlexGard Cut Resistant Glove Liners are provided to the user terminally sterilized by a validated ethylene oxide process. The FlexGard Cut Resistant Glove Liners are labeled for single use.
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The FlexGard Cut Resistant Glove Liners provide protection against cuts and slashes. The FlexGard Cut Resistant Glove Liners are not puncture resistant or cut proof.
Intended Use of the Device
The FlexGard Cut-Resistant Glove Liners are single use glove liners intended to help with protection against cuts when used with an inner and outer surgical glove. The Glove Liner must be worn between two surgical gloves.
| Technological Comparison Table | |||
|---|---|---|---|
| Feature | FlexGard® Cut-Resistant GloveLinersK190782 | Gammex® Cut Resistant Glove Liner(Primary Predicate K160974) | Discussion ofFeatureComparison |
| Product Code, | KGO | KGO | Identical |
| Classification | 21 CFR 878.4460 Surgical Glove(Accessory), Class I | 21 CFR 878.4460 Surgical Glove(Accessory), Class I | |
| Indications forUse | The FlexGard® Cut-Resistant GloveLiners are single use glove linersintended to help with protection againstcuts when used with an inner and outersurgical glove. The glove liner must beworn between two surgical gloves. | The Gammex(R) Cut Resistant GloveLiner is a single use glove liner intendedto provide ANSI/ISEA 105 Cut LevelProtection 2 against cuts when usedwith an inner and outer surgical glove.The glove liner should be worn betweentwo surgical gloves. | Similar |
| Design | Knitted glove, ambidextrous | Knitted glove, ambidextrous | Similar |
| Cuff size feature | Color coded cuff band to reflect size | Color coded cuff band to reflect size | Similar |
| Material | High density polyethylene | High strength polyethylene | Similar |
| Cut Protection | ANSI / ISEA 105, Level 2 cut resistancetested toASTM F1790-05. | ANSI Cut Level 2 tested toASTM F1790-97 | Same |
| Single use,disposable | Yes | Yes | Same |
| Provided sterile | Yes | Yes | Same |
| Sterilizationmethod | Ethylene Oxide | Gamma Irradiation | Different |
| SterilityAssurance Level(SAL) | 10-6 | 10-6 | Same |
| Sterile barrierpackage | Tyvek Pouch | Double Tyvek Pouch | Different |
| Shelf life | 2 years | Unknown | Different |
| Biocompatibilityevaluation | Cytotoxicity, Irritation, Sensitization | Cytotoxicity, Irritation, Sensitization | Same |
| Sizes | Six (6):Small (S) | Five (5):Extra Small (XS) | Similar |
| Technological Comparison Table | |||
| Feature | FlexGard® Cut-Resistant GloveLinersK190782 | Gammex® Cut Resistant Glove Liner(Primary Predicate K160974) | Discussion ofFeatureComparison |
| Medium (M) | Small (S) | ||
| Large (L) | Medium (M) | ||
| Extra-Large (XL) | Large (L) | ||
| Two-Extra-Large (2XL) | Extra Large (XL) | ||
| Three-Extra-Large (3XL) |
Summary of Technological Characteristics
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Summary of Nonclinical Performance Test
Non-clinical testing was performed to demonstrate the subject device met the acceptance criteria of the standards used to evaluate the functionality of the device.
| Test | Test Method Summary | AcceptanceCriteria | Result |
|---|---|---|---|
| Cut Protection toANSI/ISEALevel 2 cutresistance. | Cut protection of the FlexGard Cut Resistant GloveLiners has been demonstrated to ANSI/ISEA 105-2011, Level 2 by application of the ASTM F1790-05test method after ethylene oxide sterilization,simulated distribution and two-year real time aging. | Meetrequirements forANSI/ISEA 105-2011, Level 2 cutresistance. | Pass |
| Sterility | FlexGard Cut Resistant Glove Liners are terminallyethylene oxide sterilized devices, by a validated EtOsterilization cycle, per ANSI/AAMI/ISO 11135-1:2007. | Sterilityassurance level(SAL) of 10-6. | Pass |
| The FlexGard Cut-Resistant Glove Liner sterilebarrier package is a Tyvek pouch. The methodsapplied to evaluate the Tyvek pouch integrity postterminal sterilization by simulated distribution incompliance with ASTM 4169:2016, Tyvek pouchseal strength evaluated per ASTM F88/F88M-15,and Tyvek pouch integrity evaluated by ASTMF2096-11, Standard Test Method for Detecting GrossLeaks in Porous Medical Packaging by InternalPressurization (Bubble Leak). | The sterilebarrier Tyvekpouch must havea seal strength$\geq$ 1 lbf and notleak. | Pass | |
| Biocompatibility | The following test methods were applied to finalfinished form FlexGard Cut Resistant Glove Liner,with passing results:• Cytotoxicity by ANSI/AAMI/ISO 10993-5:2009(R)2014 | Cytotoxicitypasses for aGrade of $\leq$ 2. | PassGrade = 1 |
| • Sensitization by ANSI/AAMI/ISO 10993-10:2010(R)2014 | Sensitizationpasses for aGrade = 0. | PassGrade = 0 | |
| • Irritation by ANSI/AAMI/ISO 10993-10:2010(R)2014 | Irritation passesfor a PrimaryIrritation Index$\leq$ 0.4 | PassPrimary IrritationIndex = 0 |
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| Test | Test Method Summary | AcceptanceCriteria | Result |
|---|---|---|---|
| Shelf life two (2)years (real timeaging) | Shelf life testing of FlexGard Cut Resistant GloveLiners cut resistance to ANSI/ISEA 105-2011, Level2 by application of the ASTM F1790-05 test methodafter two years of real time aging.Tyvek sterile barrier pouch integrity after two yearsof real time aging evaluated for seal strength perASTM F88/F88M-15, and Tyvek pouch integrityevaluated by ASTM F2096-11, Standard TestMethod for Detecting Gross Leaks in PorousMedical Packaging by Internal Pressurization(Bubble Leak). | Meetrequirements forANSI/ISEA 105-2011, Level 2 cutresistance.The sterilebarrier Tyvekpouch must havea seal strength$\u2265$ 1 lbf and notleak. | Pass |
Clinical data is not needed for this submission.
Conclusion
The conclusions drawn from nonclinical tests demonstrate that the FlexGard Cut Resistant Glove Liners are as safe, as effective and performs well as or better than the legally marketed device Gammex® Cut Resistant Glove Liner, cleared to market by K160974.
§ 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).