(92 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of a glove liner, with no mention of AI or ML technologies.
No
The device is described as a glove liner intended to provide cut protection to surgical gloves, not to treat or cure a medical condition.
No
Explanation: The device is a cut-resistant glove liner designed to protect against cuts, not to diagnose any medical condition. Its intended use and description clearly state its protective function.
No
The device description clearly indicates that the device is a physical glove liner, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide cut protection when used with surgical gloves. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the physical properties and function of the glove liner as a protective layer.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Cut Protection to ANSI/ISEA Level 2 cut resistance.
Test Method Summary: Cut protection of the FlexGard Cut Resistant Glove Liners has been demonstrated to ANSI/ISEA 105-2011, Level 2 by application of the ASTM F1790-05 test method after ethylene oxide sterilization, simulated distribution and two-year real time aging.
Acceptance Criteria: Meet requirements for ANSI/ISEA 105-2011, Level 2 cut resistance.
Result: Pass
Test: Sterility
Test Method Summary: FlexGard Cut Resistant Glove Liners are terminally ethylene oxide sterilized devices, by a validated EtO sterilization cycle, per ANSI/AAMI/ISO 11135-1:2007.
Acceptance Criteria: Sterility assurance level (SAL) of 10-6.
Result: Pass
Test: Sterile barrier package
Test Method Summary: The FlexGard Cut-Resistant Glove Liner sterile barrier package is a Tyvek pouch. The methods applied to evaluate the Tyvek pouch integrity post terminal sterilization by simulated distribution in compliance with ASTM 4169:2016, Tyvek pouch seal strength evaluated per ASTM F88/F88M-15, and Tyvek pouch integrity evaluated by ASTM F2096-11, Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Leak).
Acceptance Criteria: The sterile barrier Tyvek pouch must have a seal strength >= 1 lbf and not leak.
Result: Pass
Test: Biocompatibility
Test Method Summary: The following test methods were applied to final finished form FlexGard Cut Resistant Glove Liner, with passing results:
• Cytotoxicity by ANSI/AAMI/ISO 10993-5:2009 (R)2014
• Sensitization by ANSI/AAMI/ISO 10993-10:2010 (R)2014
• Irritation by ANSI/AAMI/ISO 10993-10:2010 (R)2014
Acceptance Criteria: Cytotoxicity passes for a Grade of = 1 lbf and not leak.
Result: Pass
Clinical data is not needed for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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 Corporation
3560 Lafayette Road
Building 2, Suite C
Portsmouth, NH 03801 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Lou LaMarca, CEO
LDI Corporation
Phone: 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 I
Product Code: KGO
Class I |
| Predicate Devices: | K160974
Gammex® Cut Resistant Glove Liner
Ansell 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.
4
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 Glove | ||
| Liners | |||
| K190782 | Gammex® Cut Resistant Glove Liner | ||
| (Primary Predicate K160974) | Discussion of | ||
| Feature | |||
| Comparison | |||
| 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 for | |||
| Use | 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 Gammex(R) Cut Resistant Glove | ||
| Liner is a single use glove liner intended | |||
| to provide ANSI/ISEA 105 Cut Level | |||
| Protection 2 against cuts when used | |||
| with an inner and outer surgical glove. | |||
| The glove liner should be worn between | |||
| two 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 resistance | ||
| tested to | |||
| ASTM F1790-05. | ANSI Cut Level 2 tested to | ||
| ASTM F1790-97 | Same | ||
| Single use, | |||
| disposable | Yes | Yes | Same |
| Provided sterile | Yes | Yes | Same |
| Sterilization | |||
| method | Ethylene Oxide | Gamma Irradiation | Different |
| Sterility | |||
| Assurance Level | |||
| (SAL) | 10-6 | 10-6 | Same |
| Sterile barrier | |||
| package | Tyvek Pouch | Double Tyvek Pouch | Different |
| Shelf life | 2 years | Unknown | Different |
| Biocompatibility | |||
| evaluation | 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 Glove | ||
| Liners | |||
| K190782 | Gammex® Cut Resistant Glove Liner | ||
| (Primary Predicate K160974) | Discussion of | ||
| Feature | |||
| Comparison | |||
| 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
5
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 | Acceptance
Criteria | Result |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------|
| Cut Protection to
ANSI/ISEA
Level 2 cut
resistance. | Cut protection of the FlexGard Cut Resistant Glove
Liners has been demonstrated to ANSI/ISEA 105-
2011, Level 2 by application of the ASTM F1790-05
test method after ethylene oxide sterilization,
simulated distribution and two-year real time aging. | Meet
requirements for
ANSI/ISEA 105-
2011, Level 2 cut
resistance. | Pass |
| Sterility | FlexGard Cut Resistant Glove Liners are terminally
ethylene oxide sterilized devices, by a validated EtO
sterilization cycle, per ANSI/AAMI/ISO 11135-1:
2007. | Sterility
assurance level
(SAL) of 10-6. | Pass |
| | The FlexGard Cut-Resistant Glove Liner sterile
barrier package is a Tyvek pouch. The methods
applied to evaluate the Tyvek pouch integrity post
terminal sterilization by simulated distribution in
compliance with ASTM 4169:2016, Tyvek pouch
seal strength evaluated per ASTM F88/F88M-15,
and Tyvek pouch integrity evaluated by ASTM
F2096-11, Standard Test Method for Detecting Gross
Leaks in Porous Medical Packaging by Internal
Pressurization (Bubble Leak). | The sterile
barrier Tyvek
pouch must have
a seal strength
$\geq$ 1 lbf and not
leak. | Pass |
| Biocompatibility | The following test methods were applied to final
finished form FlexGard Cut Resistant Glove Liner,
with passing results:
• Cytotoxicity by ANSI/AAMI/ISO 10993-5:2009
(R)2014 | Cytotoxicity
passes for a
Grade of $\leq$ 2. | Pass
Grade = 1 |
| | • Sensitization by ANSI/AAMI/ISO 10993-10:2010
(R)2014 | Sensitization
passes for a
Grade = 0. | Pass
Grade = 0 |
| | • Irritation by ANSI/AAMI/ISO 10993-10:2010
(R)2014 | Irritation passes
for a Primary
Irritation Index
$\leq$ 0.4 | Pass
Primary Irritation
Index = 0 |
6
| Test | Test Method Summary | Acceptance
Criteria | Result |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Shelf life two (2)
years (real time
aging) | Shelf life testing of FlexGard Cut Resistant Glove
Liners cut resistance to ANSI/ISEA 105-2011, Level
2 by application of the ASTM F1790-05 test method
after two years of real time aging.
Tyvek sterile barrier pouch integrity after two years
of real time aging evaluated for seal strength per
ASTM F88/F88M-15, and Tyvek pouch integrity
evaluated by ASTM F2096-11, Standard Test
Method for Detecting Gross Leaks in Porous
Medical Packaging by Internal Pressurization
(Bubble Leak). | Meet
requirements for
ANSI/ISEA 105-
2011, Level 2 cut
resistance.
The sterile
barrier Tyvek
pouch must have
a seal strength
$\u2265$ 1 lbf and not
leak. | 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.