FlexGard Cut-Resistant Glove Liners

K190782 · Ldi Corporation · KGO · Jun 27, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190782
• Device Name: FlexGard Cut-Resistant Glove Liners
• Applicant: Ldi Corporation
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jun 27, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

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.

Device Story

FlexGard Cut-Resistant Glove Liners are single-use, ambidextrous, knitted high-density polyethylene liners. Worn between two surgical gloves, they provide supplemental cut resistance during surgical procedures. The device is terminally sterilized via ethylene oxide and packaged in a Tyvek pouch. It is intended for use by healthcare professionals in clinical settings to reduce the risk of cuts or slashes to the hands during surgery. The device does not provide puncture resistance or full cut-proof protection.

Clinical Evidence

No clinical data. Bench testing only. Performance demonstrated via ANSI/ISEA 105-2011 Level 2 cut resistance testing (ASTM F1790-05), sterility validation (ANSI/AAMI/ISO 11135-1:2007), sterile barrier integrity (ASTM F88/F88M-15, ASTM F2096-11), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Material: High-density polyethylene. Design: Knitted, ambidextrous glove. Cut resistance: ANSI/ISEA 105 Level 2 (ASTM F1790-05). Sterilization: Ethylene Oxide (SAL 10^-6). Packaging: Tyvek pouch. Shelf life: 2 years.

Indications for Use

Indicated for use as a single-use glove liner to provide cut protection when worn between two surgical gloves.

Regulatory Classification

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.

Predicate Devices

• Gammex® Cut Resistant Glove Liner (K160974)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Corporation<br>3560 Lafayette Road<br>Building 2, Suite C<br>Portsmouth, NH 03801 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Lou LaMarca, CEO<br>LDI Corporation<br>Phone: [phone] |
| 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)<br>21 CFR 878.4460 Surgical Glove (Accessory), Class I<br>Product Code: KGO<br>Class I |
| Predicate Devices: | K160974<br>Gammex® Cut Resistant Glove Liner<br>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.

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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 Glove<br>Liners<br>K190782 | Gammex® Cut Resistant Glove Liner<br>(Primary Predicate K160974) | Discussion of<br>Feature<br>Comparison |
| Product Code, | KGO | KGO | Identical |
| Classification | 21 CFR 878.4460 Surgical Glove<br>(Accessory), Class I | 21 CFR 878.4460 Surgical Glove<br>(Accessory), Class I | |
| Indications for<br>Use | The FlexGard® Cut-Resistant Glove<br>Liners are single use glove liners<br>intended to help with protection against<br>cuts when used with an inner and outer<br>surgical glove. The glove liner must be<br>worn between two surgical gloves. | The Gammex(R) Cut Resistant Glove<br>Liner is a single use glove liner intended<br>to provide ANSI/ISEA 105 Cut Level<br>Protection 2 against cuts when used<br>with an inner and outer surgical glove.<br>The glove liner should be worn between<br>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<br>tested to<br>ASTM F1790-05. | ANSI Cut Level 2 tested to<br>ASTM F1790-97 | Same |
| Single use,<br>disposable | Yes | Yes | Same |
| Provided sterile | Yes | Yes | Same |
| Sterilization<br>method | Ethylene Oxide | Gamma Irradiation | Different |
| Sterility<br>Assurance Level<br>(SAL) | 10-6 | 10-6 | Same |
| Sterile barrier<br>package | Tyvek Pouch | Double Tyvek Pouch | Different |
| Shelf life | 2 years | Unknown | Different |
| Biocompatibility<br>evaluation | Cytotoxicity, Irritation, Sensitization | Cytotoxicity, Irritation, Sensitization | Same |
| Sizes | Six (6):<br>Small (S) | Five (5):<br>Extra Small (XS) | Similar |
| Technological Comparison Table | | | |
| Feature | FlexGard® Cut-Resistant Glove<br>Liners<br>K190782 | Gammex® Cut Resistant Glove Liner<br>(Primary Predicate K160974) | Discussion of<br>Feature<br>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

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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 | Acceptance<br>Criteria | Result |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------|
| Cut Protection to<br>ANSI/ISEA<br>Level 2 cut<br>resistance. | Cut protection of the FlexGard Cut Resistant Glove<br>Liners has been demonstrated to ANSI/ISEA 105-<br>2011, Level 2 by application of the ASTM F1790-05<br>test method after ethylene oxide sterilization,<br>simulated distribution and two-year real time aging. | Meet<br>requirements for<br>ANSI/ISEA 105-<br>2011, Level 2 cut<br>resistance. | Pass |
| Sterility | FlexGard Cut Resistant Glove Liners are terminally<br>ethylene oxide sterilized devices, by a validated EtO<br>sterilization cycle, per ANSI/AAMI/ISO 11135-1:<br>2007. | Sterility<br>assurance level<br>(SAL) of 10-6. | Pass |
| | The FlexGard Cut-Resistant Glove Liner sterile<br>barrier package is a Tyvek pouch. The methods<br>applied to evaluate the Tyvek pouch integrity post<br>terminal sterilization by simulated distribution in<br>compliance with ASTM 4169:2016, Tyvek pouch<br>seal strength evaluated per ASTM F88/F88M-15,<br>and Tyvek pouch integrity evaluated by ASTM<br>F2096-11, Standard Test Method for Detecting Gross<br>Leaks in Porous Medical Packaging by Internal<br>Pressurization (Bubble Leak). | The sterile<br>barrier Tyvek<br>pouch must have<br>a seal strength<br>$\geq$ 1 lbf and not<br>leak. | Pass |
| Biocompatibility | The following test methods were applied to final<br>finished form FlexGard Cut Resistant Glove Liner,<br>with passing results:<br>• Cytotoxicity by ANSI/AAMI/ISO 10993-5:2009<br>(R)2014 | Cytotoxicity<br>passes for a<br>Grade of $\leq$ 2. | Pass<br>Grade = 1 |
| | • Sensitization by ANSI/AAMI/ISO 10993-10:2010<br>(R)2014 | Sensitization<br>passes for a<br>Grade = 0. | Pass<br>Grade = 0 |
| | • Irritation by ANSI/AAMI/ISO 10993-10:2010<br>(R)2014 | Irritation passes<br>for a Primary<br>Irritation Index<br>$\leq$ 0.4 | Pass<br>Primary Irritation<br>Index = 0 |

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| Test | Test Method Summary | Acceptance<br>Criteria | Result |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Shelf life two (2)<br>years (real time<br>aging) | Shelf life testing of FlexGard Cut Resistant Glove<br>Liners cut resistance to ANSI/ISEA 105-2011, Level<br>2 by application of the ASTM F1790-05 test method<br>after two years of real time aging.<br>Tyvek sterile barrier pouch integrity after two years<br>of real time aging evaluated for seal strength per<br>ASTM F88/F88M-15, and Tyvek pouch integrity<br>evaluated by ASTM F2096-11, Standard Test<br>Method for Detecting Gross Leaks in Porous<br>Medical Packaging by Internal Pressurization<br>(Bubble Leak). | Meet<br>requirements for<br>ANSI/ISEA 105-<br>2011, Level 2 cut<br>resistance.<br>The sterile<br>barrier Tyvek<br>pouch must have<br>a seal strength<br>$\u2265$ 1 lbf and not<br>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.