Halyard Black-Orange Powder-Free Nitrile Exam Glove

K153708 · Halyard Health · LZA · Mar 31, 2016 · General Hospital

Device Facts

• Record ID: K153708
• Device Name: Halyard Black-Orange Powder-Free Nitrile Exam Glove
• Applicant: Halyard Health
• Product Code: LZA · General Hospital
• Decision Date: Mar 31, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Disposable, non-sterile, ambidextrous nitrile patient examination glove; features textured fingertips and dual-color design (black grip side, orange donning side). Manufactured via two-layer nitrile dipping process. Used in clinical settings by healthcare professionals to provide a barrier against contamination between patient and examiner. Device is worn on the hand; no electronic or mechanical components. Benefits include protection against cross-contamination during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D5151 (leakage), ASTM D6319 (physical dimensions, tensile strength, elongation), ASTM D6124 (residual powder), and ISO 10993 (irritation, sensitization, systemic toxicity). All results met acceptance criteria.

Technological Characteristics

Nitrile material; two-layer dipping process; black/orange colorants; textured fingertip; powder-free; non-sterile; ambidextrous. Conforms to ASTM D5151, ASTM D6319, ASTM D6124, ISO 10993-10, and ISO 10993-11.

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hand to prevent contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

• Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves (K081260)

Submission Summary (Full Text)

{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 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 [phone] or [phone] 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 [phone] or [phone] 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.

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 [e-mail]

"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<br>was Prepared: | December 21, 2015<br>Rev: 2/26/16 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Christine L. Macauley<br>Requlatory Affairs Technical Leader<br>Halyard Health<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>Email: [e-mail]<br>Ph: 470-448-5158 |
| Primary Contact for<br>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<br>and Classification Name: | LZA<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove |
| Predicate Device: | K081260<br>Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves |
| Subject Device Description: | Halyard® Black-Orange Powder-Free Nitrile Exam Gloves are disposable,<br>black-colored on the grip side and orange colored on the donning side, nitrile,<br>powder-free, textured fingertip, ambidextrous, non-sterile patient examination<br>gloves that are chlorinated on the donning side and are packed in a cardboard<br>dispenser box. |
| Intended Use: | The Halyard® Black-Orange Powder-Free Nitrile Exam Glove is a disposable<br>device intended for medical purposes that is worn on the examiner's hand to<br>prevent contamination between patient and examiner. |

| | Subject Device | Predicate Device<br>K081260 | Substantially<br>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<br>Powder-Free Exam Glove | Kimberly-Clark Lavender Nitrile Powder-<br>Free Exam Glove | Yes |
| Intended Use | The Halyard Black-Orange Powder-<br>Free Nitrile Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | The Kimberly-Clark Lavender Nitrile<br>Powder-Free Nitrile Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | Yes |

{4}------------------------------------------------

| | Subject Device | Predicate Device K081260 | Substantially<br>Equivalent | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Technological<br>Characteristics | Black on the grip side, orange on the<br>donning side, nitrile, powder-free,<br>textured fingertip, ambidextrous, non-<br>sterile patient examination glove. | Lavender colored, nitrile, powder-free,<br>textured fingertip, ambidextrous, non-<br>sterile patient examination glove. | Yes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Performance Data<br>ASTM D5151 Standard Test<br>Method for Detection of<br>Holes in Medical Gloves | Testing of the subject device shows it<br>meets the 2.5 AQL requirement in the<br>standards for leakage. The device<br>meets the acceptance criteria of the<br>standard. PASS | Testing of the subject device shows it<br>meets the 2.5 AQL requirement in the<br>standards for leakage. The device<br>meets the acceptance criteria of the<br>standard. PASS | Yes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| ASTM D6319 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>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<br>Tensile ≥14 MPa ≥16 MPa Unaged<br>Elongation ≥500% ≥500% Aged<br>Tensile ≥14 MPa ≥15 MPa Aged<br>Elongation ≥400% ≥450% Powder ≤2mg/glove ≤2mg/glove | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | The physical dimensions of the<br>subject device are within the limits of<br>the standard and the physical<br>properties of the subject device meet<br>the requirements for tensile strength<br>and elongation in the standard.<br>Therefore the device meets the<br>acceptance criteria of the standard.<br>PASS | Yes |
| ASTM D6124 Standard Test<br>Method for Residual Powder<br>on Medical Gloves | PASS<br>Residual powder on the subject<br>device is within the powder-free limit<br>of < 2 mg maximum powder per glove<br>and meets the acceptance criteria for<br>powder-free. PASS | Residual powder on the subject<br>device is within the powder-free limit<br>of < 2 mg maximum powder per glove<br>and meets the acceptance criteria for<br>powder-free. PASS | Yes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| ISO 10993-10 Biological<br>evaluation of medical<br>devices -Tests for Irritation | Acceptance criteria: No erythema/<br>edema up to 72 hours post exposure.<br>Result: Erythema/edema was<br>negligible. Meets acceptance criteria.<br>PASS | Acceptance criteria: No erythema/<br>edema up to 72 hours post exposure.<br>Result: Erythema/edema was<br>negligible. Meets acceptance criteria.<br>PASS | Yes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| ISO 10993-10 Biological<br>evaluation of medical<br>devices -Tests for Skin<br>Sensitization | Acceptance criteria: No evidence of<br>delayed dermal contact sensitivity at<br>24 and 48 hours post injection.<br>Result: Not a sensitizer under<br>conditions of the study. Meets<br>acceptance criteria. PASS | Acceptance criteria: No evidence of<br>delayed dermal contact sensitivity at<br>24 and 48 hours post injection.<br>Result: Not a sensitizer under<br>conditions of the study. Meets<br>acceptance criteria. PASS | Yes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

{5}------------------------------------------------

## Halyard Health 510(k) for the Halyard Black-Orange Powder-Free Nitrile Exam Glove

| ISO 10993 Biological<br>evaluation of medical<br>devices - Tests for<br>Systemic Toxicity | Acceptance criteria: No signs of<br>systemic toxicity up to 72 hours post<br>injection.<br>Result: No systemic toxicity<br>observed.<br>Meets acceptance criteria. PASS | Acceptance criteria: No signs of<br>systemic toxicity up to 72 hours post<br>injection.<br>Result: No systemic toxicity<br>observed.<br>Meets acceptance criteria. PASS | Yes |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Conclusion | The performance data support the conclusion that the subject device is as safe, as effective, and<br>performs as well as the legally marketed device that was submitted and cleared under K081260. | | |

| Technological Characteristics<br>and Substantial Equivalence: | The Halyard® Black-Orange Powder-Free Nitrile Exam Glove is<br>substantially equivalent to the predicate device, Kimberly-Clark<br>Lavender Nitrile Powder-Free Exam Gloves (K081260). The only<br>difference is the use of different colorants that have been tested<br>for biocompatibility and a two-layer nitrile dipping process that<br>enables each of the two glove surfaces (donning surface and grip<br>surface) to have a different color. These new colorants and<br>additional nitrile layer raise no new issues of safety and efficacy<br>as demonstrated by testing of biocompatibility and technical<br>product performance as described in this 510(k) submission. |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Testing: | These gloves have been tested for conformance to the applicable<br>sections of the following standards: |
| | ASTM D5151-06 Standard Test Method for Detection of Holes in<br>Medical Gloves |
| | ASTM D6319-10 Standard Specification for Nitrile Examination<br>Gloves for Medical Applications |
| | ASTM D6124-06 Standard Test Method for Residual Powder on<br>Medical Gloves |
| | ISO 10993-10 Biological evaluation of medical devices -Tests for<br>Irritation and Skin Sensitization |
| | ISO 10993-11 Biological evaluation of medical devices - Tests for<br>Systemic Toxicity |
| | ALL RESULTS OF TESTING MET ACCEPTANCE CRITERIA. |
| Brief Description of Clinical<br>Tests: | No new clinical tests were required to support this 510(k)<br>notification. |
| CONCLUSION: | The performance data support the conclusion that the subject<br>device is as safe, as effective, and performs as well as the legally<br>marketed device that was submitted and cleared under<br>K081260. |