(146 days)
Not Found
No
The 510(k) summary describes a physical glove liner and its performance in cut resistance and biocompatibility testing, with no mention of software, algorithms, or AI/ML technologies.
No
The device is intended to provide protection against accidental cuts, not to treat or diagnose a medical condition or disease.
No
The device, a cut-resistant glove liner, is designed for protection against accidental cuts, not for diagnosing any medical condition.
No
The device is a physical glove liner made from high strength polyethylene, 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 resistance when worn between surgical gloves. This is a physical barrier function for protection during surgical procedures.
- Device Description: The description focuses on the material (high strength polyethylene) and its purpose (extra protection against accidental cuts).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze biological samples.
This device is clearly intended for in vivo use (on or within the body, in this case, on the hands of surgical personnel) as a protective measure.
N/A
Intended Use / Indications for Use
The Zimmer Cut Resistant Glove Liners are intended to provide moderate cut resistance when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.
Product codes
KGO
Device Description
The Zimmer Cut Resistant Glove Liner is designed to provide the surgeon, assistant, scrub nurse or any surgical arena personnel extra protection in the event of an accidental cut when used as a liner to a surgical glove. The Zimmer Cut Resistant Glove Liner is produced from high strength polyethylene.
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
surgeon, assistant, scrub nurse or any surgical arena personnel
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 Performance and Conclusions: Non-clinical performance data was demonstrated to meet the ASTM 1790-04 requirements for cut resistance. The glove liners were tested in accordance with ANSI/AAMI/ISO 10993-1:1997, "Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing". Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in lowercase letters. A horizontal line is placed beneath the word "zimmer".
Traditional 510(k) Premarket Notification
Summary of Safety and Effectiveness
APR 2 6 2007
Submitter: Zimmer Orthopaedic Surgical Products. 200 West Ohio Avenue P.O. Box 10 Dover, Ohio 44622
Cindy J. Dickey Regulatory Compliance Manager Telephone: (330) 364-9493 Fax: (330) 364-9490
November 28, 2006
Zimmer™ Cut Resistant Glove Liners
Glove Liner
Surgeon's Glove (accessory to) 21 CFR § 878.4460
Cut Resistant Surgical Glove Liner, manufactured by Wells Lamont, K922407, cleared June 15, 1993
While cut resistant glove liners do not protect against punctures, especially punctures presented by means of sharp needles or sharp instrument tips, they will provide moderate protection against cuts and abrasion. Cut resistant glove liners have been shown to reduce the risk of inner glove perforations and reduce the risk of contamination from patient's blood.4 Even with the limitations, researchers still recommend the use of cut resistant glove liners when bone fragments are being manipulated or when using sharp instruments.
The Zimmer Cut Resistant Glove Liner is designed to provide the surgeon, assistant, scrub nurse or any surgical arena personnel extra protection in the event of an accidental cut when used as a liner to a surgical glove. The Zimmer Cut Resistant Glove Liner is produced from high strength polyethylene.
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Device:
Device Description:
1
Image /page/1/Picture/0 description: The image shows the Zimmer company logo. The logo consists of a large, bold letter 'Z' enclosed in a circle, followed by the word 'zimmer' in lowercase letters. The text is in a bold, sans-serif font and is black in color.
The Zimmer Cut Resistant Glove Liners are
gloves.
intended to provide moderate cut resistance when used with an inner and outer surgical glove. The glove liner should be worn between two surgical
Both products are an ultra high molecular weight polyethylene that offers high cut resistance. Either manufactured fiber will provide compliant cut resistance when tested in accordance to ASTM1790-04.
Indications for Use:
Comparison to Predicate Device:
The Zimmer Cut Resistant Glove Liners are substantially equivalent to the legally marketed glove liners, specifically the Wells Lamont Cut Resistant Glove Liners in that the devices are similar in design, materials, and indications for use. The Wells Lamont Cut Resistant Glove Liners are cut resistant gloves, which provide protection from cuts, slashes, and sharp instruments. For optimum barrier protection, it is suggested that a surgical glove be worn over and under Spec-Tec Cut resistant gloves.
Both the proposed and predicate devices are offered in a variety of sizes. Sizing is depicted with color coded cuff bands.
Performance Data (Nonclinical and/or Clinical):
Performance Data (Nonclinical
Non-Clinical Performance and Conclusions:
Non-clinical performance data was demonstrated to meet the ASTM 1790-04 requirements for cut resistance.
The glove liners were tested in accordance with ANSI/AAMI/ISO 10993-1:1997, "Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing".
Non-Clinical Performance and Conclusions:
2
Image /page/2/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a circle with a stylized "Z" inside, followed by the word "zimmer" in lowercase letters. A horizontal line is located underneath the word "zimmer".
Traditional 510(k) Premarket Notification
and/or Clinical):
The Guidance for Industry and FDA, "Medical Glove Guidance Manual." was consulted.
Performance Data (Nonclinical and/or Clinical): Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the human form. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular pattern. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cindy J. Dickey Regulatory Compliance Manager Zimmer, Incorporated Zimmer Orthopaedic Surgical Products 200 West Ohio Avenue P.O. Box 10 Dover, Ohio 44622-0010
APR 2 6 2007
Re: K063582
Trade/Device Name: Zimmer™ Cut Resistant Glove Liners Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 30, 2007 Received: April 4, 2007
Dear Ms. Dickey:
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.
4
Page 2 - Ms. Dickey
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 Part 807); labeling (21 CFR Part 801); 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.
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.
Susan Puma
Chiu 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
5
Indications for Use
KO635B2 510(k) Number (if known):
Device Name:
Zimmer TM Cut Resistant Glove Liners
Indications for Use;
The Zimmer Cut Resistant Glove Liners are intended to provide moderate cut resistance when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela L. Mingsley, 40
-sion of Anesthesiology, General Hospital I ... Caron Control, Dental Devices
ೆ(k) Number _________________________________________________________________________________________________________________________________________________________________