(149 days)
Not Found
No
The device is a disposable exam glove and the description and performance studies focus on physical properties and safety, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is an exam glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical glove, not software. The description clearly outlines its material (nitrile), physical characteristics (powder-free, textured fingertip), and intended use as a disposable device worn on the hand.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details a physical barrier (a glove) and its material properties. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, assays, or any other elements typically associated with in vitro diagnostics.
Therefore, the Halyard® Fusion Black Powder-Free Nitrile Exam Glove is a medical device, but it falls under the category of a barrier device for infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Halyard ® Fusion Black Powder-Free Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Halyard® Fusion Black Powder-Free Nitrile Exam Gloves are disposable, black-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves which are chlorinated on the donning side and are packed in a cardboard dispenser box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
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)
The device was tested for conformance to the following standards:
ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves: Testing of the subject device shows it meets the 2.5 AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard.
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications: The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device meet the requirements for tensile strength and elongation in the standard. Therefore the device meets the acceptance criteria of the standard.
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves: Residual powder on the subject device is within the powder-free limit of
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus-like symbol with three human profiles facing right, representing health and human services. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2015
Halyard Health Ms. Christine L Macauley Technical Leader, Regulatory Affairs 5405 Windward Parkway Alpharetta, GA 30004
Re: K150113
Trade/Device Name: Fusion Black Powder-Free Nitrile Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Medical Exam Gloves Regulatory Class: I Product Code: LZA Dated: May 19, 2015 Received: May 21, 2015
Dear Ms. Macauley:
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.
1
Page 2 - Ms. Macauley
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); medical device reporting (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K150113
Device Name
Halyard® Fusion Black Powder-Free Nitrile Exam Glove
The Halyard ® Fusion Black Powder-Free Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 2 – 510(k) Summary
| Date Summary was
| Prepared: | June 16, 2015 |
|---|---|
| 510(k) Submitter: | Christine L. Macauley |
| Regulatory Affairs Technical Leader | |
| Halyard Health | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| Ph: 470-448-5158 | |
| Email: Chris.Macauley@hyh.com | |
| Primary Contact for | |
| this 510(k) | |
| Submission: | Same |
| Halyard Health | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| Device Trade | |
| Name: | Halyard® Fusion Black Powder-Free Nitrile Exam Glove |
| Device Common | |
| Name: | Medical Exam Gloves |
| Device Product | |
| Code and | |
| Classification | |
| Name: | LZA |
| Class I, 21 CFR §880.6250 | |
| Patient Examination Glove | |
| Predicate Device: | K081260 |
| Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves | |
| Subject Device | |
| Description: | Halyard® Fusion Black Powder-Free Nitrile Exam Gloves are disposable, black-colored, nitrile, |
| powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves which are | |
| chlorinated on the donning side and are packed in a cardboard dispenser box. | |
| Intended Use: | The Halyard® Fusion Powder-Free Nitrile Exam Glove is a disposable device intended for |
| medical purposes that is worn on the examiner's hand to prevent contamination between | |
| patient and examiner. |
| | Subject Device | Predicate Device
K081260 | Substantially
Equivalent |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| FDA Product Code | LZA | LZA | Yes |
| FDA Classification | Class 1 | Class 1 | Yes |
| Common Name | Medical Exam Glove | Medical Exam Glove | Yes |
| Device Trade Name | Halyard Fusion Black Nitrile Powder-
Free Exam Glove | Kimberly-Clark Lavender Nitrile Powder-
Free Exam Glove | Yes |
| Intended Use | The Halyard Fusion Black Powder-
Free Nitrile Exam Glove is a
disposable device intended for
medical purposes that is worn on the
examiner's hand to prevent
contamination between patient and
examiner. | The Kimberly-Clark Lavender Nitrile
Powder-Free Nitrile Exam Glove is a
disposable device intended for
medical purposes that is worn on the
examiner's hand to prevent
contamination between patient and
examiner. | Yes |
| | Subject Device | Predicate Device
K081260 | Substantially
Equivalent |
| Technological
Characteristics | Black colored, nitrile, powder-free,
textured fingertip, ambidextrous, non-
sterile patient examination glove. | Lavender colored, nitrile, powder-free,
textured fingertip, ambidextrous, non-
sterile patient examination glove. | Yes |
| Performance Data | | | |
| ASTM D5151 Standard Test
Method for Detection of
Holes in Medical Gloves | Testing of the subject device shows it
meets the 2.5 AQL requirement in the
standards for leakage. The device
meets the acceptance criteria of the
standard. | Testing of the subject device shows it
meets the 2.5 AQL requirement in the
standards for leakage. The device meets
the acceptance criteria of the standard. | Yes |
| ASTM D6319 Standard
Specification for Nitrile
Examination Gloves for
Medical Applications | The physical dimensions of the
subject device are within the limits of
the standard and the physical
properties of the subject device meet
the requirements for tensile strength
and elongation in the standard.
Therefore the device meets the
acceptance criteria of the standard. | The physical dimensions of the subject
device are within the limits of the standard
and the physical properties of the subject
device meet the requirements for tensile
strength and elongation in the standard.
Therefore the device meets the
acceptance criteria of the standard. | Yes |
| ASTM D6124 Standard Test
Method for Residual Powder
on Medical Gloves | Residual powder on the subject
device is within the powder-free limit
of $