(99 days)
Not Found
No
The device is a disposable examination glove and the summary contains no mention of AI or ML technology.
No
The device is described as an "exam glove" intended to prevent contamination between patient and examiner, not to treat a medical condition.
No
Explanation: The device is an examination glove, intended to prevent contamination between the patient and examiner, not to diagnose a medical condition.
No
The device description clearly states it is a physical glove made of nitrile, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical characteristics of the glove (material, color, texture, etc.). There is no mention of any components or features that would be used to analyze samples or provide diagnostic information.
- Lack of Diagnostic Elements: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection of specific analytes or markers
- Use of reagents or assays
- Providing information for diagnosis, monitoring, or treatment decisions
The device is a medical device, specifically a patient examination glove, but its function is protective and preventative, not diagnostic.
N/A
Intended Use / Indications for Use
The Halyard Black-Orange 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
LZA
Device Description
Halyard® Black-Orange Powder-Free Nitrile Exam Gloves are disposable, black-colored on the grip side and orange colored on the donning side, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that 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
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)
The device was tested for conformance to the applicable sections of the following standards:
- ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves: Testing showed it meets the 2.5 AQL requirement for leakage.
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications: The physical dimensions are within limits and physical properties meet requirements for tensile strength and elongation.
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves: Residual powder 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.
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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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Halyard Health Ms. Christine Macauley Regulatory Affairs Technical Leader 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K153708
Trade/Device Name: Halyard® Black-Orange Powder-free Nitrile Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: February 29, 2016 Received: March 1, 2016
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.
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
1
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 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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) K153708
Device Name
Halyard® Black-Orange Powder-Free Nitrile Exam Glove
Indications for Use (Describe)
The Halyard Black-Orange 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Section 2 – 510(k) Summary
| Date Summary
was Prepared: | December 21, 2015
Rev: 2/26/16 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Christine L. Macauley
Requlatory Affairs Technical Leader
Halyard Health
5405 Windward Parkway
Alpharetta, GA 30004
Email: Chris.Macauley@hyh.com
Ph: 470-448-5158 |
| Primary Contact for
this 510(k) Submission: | Same as above |
| Device Trade Name: | Halyard® Black-Orange 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® Black-Orange Powder-Free Nitrile Exam Gloves are disposable,
black-colored on the grip side and orange colored on the donning side, nitrile,
powder-free, textured fingertip, ambidextrous, non-sterile patient examination
gloves that are chlorinated on the donning side and are packed in a cardboard
dispenser box. |
| Intended Use: | The Halyard® Black-Orange 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 Black-Orange Nitrile
Powder-Free Exam Glove | Kimberly-Clark Lavender Nitrile Powder-
Free Exam Glove | Yes |
| Intended Use | The Halyard Black-Orange 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 |
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| | Subject Device | Predicate Device K081260 | Substantially
Equivalent | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Technological
Characteristics | Black on the grip side, orange on the
donning side, 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. PASS | 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. PASS | Yes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| ASTM D6319 Standard
Specification for Nitrile
Examination Gloves for
Medical Applications | Property ASTM Spec Holes AQL 2.5% AQL 1.0% Length ≥230 mm 230-258 mm Width 85-105mm 85-105mm Finger ≥0.050mm .06-.09mm Palm ≥0.050mm .05-.07mm Unaged
Tensile ≥14 MPa ≥16 MPa Unaged
Elongation ≥500% ≥500% Aged
Tensile ≥14 MPa ≥15 MPa Aged
Elongation ≥400% ≥450% Powder ≤2mg/glove ≤2mg/glove | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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.
PASS | Yes |
| ASTM D6124 Standard Test
Method for Residual Powder
on Medical Gloves | PASS
Residual powder on the subject
device is within the powder-free limit
of