(204 days)
Not Found
No
The 510(k) summary describes a physical glove liner and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a cut-resistant glove liner designed to protect against cuts, not to treat or alleviate a disease or condition. Its purpose is protective, not therapeutic.
No
The device is a cut-resistant glove liner, which is a protective barrier for hands during surgery. It does not collect or analyze any physiological data or medical images to diagnose conditions. Its function is purely protective, not diagnostic.
No
The device description clearly states it is a physical glove liner made of knitted fibers, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide cut protection to the hands during surgery when worn between two surgical gloves. This is a physical barrier and protective function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details the materials and construction of a glove liner, which is a physical item.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove liner does not fit that description.
N/A
Intended Use / Indications for Use
The Gammex(R) Cut Resistant 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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Cut resistant under glove liner is a white color liner knitted from an ultrahigh molecular weight polyethylene fiber (UHMWPE) that offers ANSI/ISEA 105 Cut Level Protection against cuts. The liner is knitted using the UHMWPE as the main strengthening component along with nylon and spandex for comfort. The device is a single use device.
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
surgeons, nurse or any personal involving in surgeries
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)
A clinical study was not conducted on the subject device or the predicate device.
| Technological Characteristic | Standard | Result Summary |
|---|---|---|
| Cut level 2 | ANSI/ISEA 105 Clause 5.1.1 | Weight (g) needed to cut |
| through material ≥ 500 | ||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the |
| study, not cytotoxic | ||
| ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of the |
| study, not an irritant | ||
| ISO Maximization | ||
| Sensitization Study | ISO 10993-10:2010 | Under the conditions of the |
| study, not a sensitizer |
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
Ansell Healthcare Products LLC Mr. Robert Mahler Director, Regulatory Affairs for the Americas 111 Wood Avenue South. Suite 210 Iselin, New Jersey 08830
Re: K160974
Trade/Device Name: Gammex (R) Cut Resistant Glove Liner Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: September 28, 2016 Received: September 30, 2016
Dear Mr. Mahler:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160974
Device Name Gammex (R) Cut Resistant Glove Liner
Indications for Use (Describe)
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 imer and outer surgical glove liner should 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
1. 510(k) Summary
Submitter
Ansell Healthcare Products LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830
Contact Person:
Robert Mahler Director Regulatory Affairs for the Americas Phone: (732) 345-2174 Email: rob.mahler(@ansell.com
Date prepared:
October 25, 2016
Name of Device:
| Trade name: | Gammex® Cut Resistant Glove Liner |
|---|---|
| Common name: | Glove Liners/Undergloves |
| Classification name: | Surgeon's Glove (accessory) |
| Classification regulation: | 21 CFR 878.4460 |
| Device class: | I |
| Product code: | KGO |
| Classification panel: | General and plastic surgery |
Legally marketed predicate device:
K922407 - Wells Lamont Cut Resistant Surgical Glove Liners
Device description:
Cut resistant under glove liner is a white color liner knitted from an ultrahigh molecular weight polyethylene fiber (UHMWPE) that offers ANSI/ISEA 105 Cut Level Protection against cuts. The liner is knitted using the UHMWPE as the main strengthening component along with nylon and spandex for comfort. The device is a single use device.
Indications for use statement:
The Gammex(R) Cut Resistant 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.
Technological characteristics:
Gammex® Cut Resistant Glove Liner has the following technological characteristics as compared to ASTM or equivalent standards
4
| Technological Characteristic | Standard | Result Summary |
|---|---|---|
| Cut level 2 | ANSI/ISEA 105 Clause 5.1.1 | Weight (g) needed to cut |
| through material $\geq$ 500 | ||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the |
| study, not cytotoxic | ||
| ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of the |
| study, not an irritant | ||
| ISO Maximization | ||
| Sensitization Study | ISO 10993-10:2010 | Under the conditions of the |
| study, not a sensitizer | ||
Substantial Equivalence
| Substantial Equivalence Comparison Table |
|---|
| ------------------------------------------ |
| | Predicate Device | Subject Device | Substantially
Equivalent |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Trade Name | Wells Lamont Cut Resistant
Surgical Glove Liners | Gammex® Cut Resistant
Glove Liner | As noted |
| 510(k)
Number | K922407 | To be declared | As noted |
| Indications
for use | A cut resistant glove liner for
improved protection from
cuts, slashes, and sharp
instrument. For optimum
barrier protection, it is
suggested that a latex surgical
glove be worn over and under
the glove liner. The liner may
be reused | Cut Resistant 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. | As noted |
| Material | Ultra-high molecular weight
polyethylene fibre | Ultra-high molecular weight
polyethylene fibre | Equivalent |
| Color | White | White | Equivalent |
| Design | Knitted glove, ambidextrous,
straight fingers | Knitted glove, ambidextrous,
straight fingers | Equivalent |
| Cuff feature | Coloured coded and a label
attached on cuff to note
number of reusable. | Coloured coded and a label
attached on cuff to note
number of reusable. | Equivalent |
| Cut level | ANSI Cut Level 2 according
to ASTM F1790-97 | ANSI Cut Level 2 according
to ASTM F1790-97 | Equivalent |
| Reusable | Laundry up to the readable
guide on the cuff edge label.
Washing, drying and
disinfection with sodium
hypochlorite or alkaline
glutaraldehyde. Re-
sterilisation via auto clave or
ethylene oxide gas | Single use only | As noted |
5
| | Predicate Device | Subject Device | Substantially
Equivalent |
|---------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------|
| Sterilization | Ethylene Oxide gas
Meeting sterility assurance
level, SAL 10 -6 | Gamma Irradiation
Meeting sterility assurance
level, SAL 10-6 | As noted |
| Glove Length | XS – 6 3/8”
S - 7 1/2”
M - 8”
L - 8 3/8”
XL – 8 3/4” | XS – 6 3/8”
S - 6 7/8”
M - 7 1/8”
L - 7 1/8”
XL - 7 1/2 ” | As noted. |
The cut resistant under glove liner is a white color glove liner knitted from an ultrahigh molecular weight polyethylene (UHMWPE) fibers that offers cut resistance. The glove liner is knitted using UHMWPE varn as the main strengthening component along with Nylon and Spandex for comfort.
The cut resistance under glove is designed to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts for the hands of surgeons, nurse or any personal involving in surgeries by giving cut protection level 2 during the surgeries. The glove to be worn between two surgical glove inner and outer as a under glove.
The glove is manufactured from similar type materials to provide equivalent material, color, design, cuff feature and cut level performance as the predicate. The sterilization process though differs but achieves the required sterility. Biocompatibility was done on the subject device to show that the product was not cytotoxic, an irritant or a sensitizer consistent with the ISO 10993 series of standards.
Performance Data
A clinical study was not conducted on the subject device or the predicate device.
Substantial Equivalence Statement
The Gammex® Cut Resistant Glove Liner is substantially equivalent to the predicate device with respect to the design, technological characteristics, and conformance to standards requirements. The device differs from the predicate in that it is a single use device.