Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove

K200633 · 0 & M Halyard, Inc. · LZC · Oct 11, 2020 · General Hospital

Device Facts

• Record ID: K200633
• Device Name: Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
• Applicant: 0 & M Halyard, Inc.
• Product Code: LZC · General Hospital
• Decision Date: Oct 11, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate 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 examination gloves; textured fingertips; chlorinated donning side. Used by healthcare professionals to prevent cross-contamination between patient and examiner. Subject devices tested for permeation resistance against Fentanyl Citrate (both) and various chemotherapy drugs (Purple Nitrile only) per ASTM D6978-05. Output is a physical barrier; healthcare providers use gloves during patient examinations or chemotherapy handling to protect against chemical exposure and biological contaminants. Benefits include reduced risk of exposure to hazardous drugs and patient-to-examiner contamination.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ASTM D5151 (leakage), D6319 (physical properties), D6124 (residual powder), and D6978 (chemotherapy drug permeation). Biocompatibility confirmed via ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Nitrile rubber; powder-free; textured fingertip; ambidextrous; non-sterile. Dimensions: 230-258mm length, 85-105mm width, 0.05-0.07mm palm thickness. Tensile strength >16MPa (unaged), >15MPa (aged). Elongation >500% (unaged), >450% (aged). Residual powder <2mg/glove. Conforms to ASTM D5151, D6319, D6124, D6978.

Indications for Use

Indicated for use as a disposable patient examination glove to prevent contamination between patient and examiner. The Purple Nitrile variant is indicated for use with specific chemotherapy drugs and Fentanyl Citrate; the Black-Fire variant is indicated for use with Fentanyl Citrate. Contraindicated for use with Carmustine and ThioTEPA.

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

• Halyard Black-Orange Powder-Free Nitrile Exam Glove (K153708)
• Kimberly-Clark PURPLE NITRILE Powder-Free Exam Glove with Tested for Use with Chemotherapy Drugs (K101596)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

October 11, 2020

0 & M Halyard, Inc Steven Dowdley Associate Director of Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004

Re: K200633

Trade/Device Name: Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate; Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate

Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, QDO, LZC Dated: September 8, 2020 Received: September 10, 2020

Dear Steven Dowdley:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For: CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200633

Device Name

Halyard Black Fire Powder-Free Nitrile Exam Glove tested with Fentanyl Citrate

Indications for Use (Describe)

The Halyard Black Fire Powder-Free Nitrile Exam Glove tested with Fentany] Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following drugs showed not breakthrough at 240 minutes:

Fentanyl Citrate, 100 mcg/2ml

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | |
|----------------------------------------------|--------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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# Indications for Use

510(k) Number (if known) K200633

Device Name

Halyard Purple Nitrile Powder-Free Exam Glove tested with Chemotherapy Drugs and Fentanyl Citrate

Indications for Use (Describe)

The Halyard Purple Nitrile Powder-Free Exam Glove tested with Chemotherapy Drugs and Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following drugs showed not breakthrough at 240 minutes: Bleomycin (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (DTIC) (10.0 mg/ml) Daunorubicin (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin Hydrochloride (2.0 mg/ml) Ellence (2.0 mg/ml) Etoposide (Toposar) (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (Gemzar) (38.0 mg/ml) Idarubicin (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HC1 (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2.0 mg/ml) Paclitaxel (Taxol) (6.0 mg/ml) Paraplatin (10.0 mg/ml) Rituximab (10.0 mg/ml) Trisonex (1.0 mg/ml) Vincrinstine (1mg/ml)

Fentanyl Citrate, 100 mcg/2ml

The following drugs showed breakthrough detected in less than 30 minutes: Carmustine (3.3mg/ml) 1.8 minutes and ThioTEPA (10.0mg/ml): 1.7 minutes.

Warning- Not for use with Carmustine and ThioTEPA.

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Prescription Use (Part 21 CFR 801 Subpart D)

- X Over-The-Counter Use (21 CFR 801 Subpart C)
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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]

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# 510(k) Summary

### K200633

| Date Summary was Prepared: | October 10, 2020 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Steven Dowdley<br>Associate Director, Regulatory Affairs<br>505 Windward Parkway<br>Alpharetta, GA 30004<br>Email: [e-mail]<br>Phone: [phone] |
| Primary Contact for this 510(k): | Same as above |
| Device1 Trade Name: | Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with<br>Fentanyl Citrate |
| Device2 Trade Name: | Halyard Purple Nitrile Powder-Free Exam Glove tested for use with<br>Chemotherapy Drugs and Fentanyl Citrate |
| Common Name: | Powder Free Nitrile Patient Examination Glove |
| Device1 Product Code: | LZA, QDO |
| Device2 Product Code: | LZC, QDO |
| Classification: | Class I |
| Regulation: | 21 CFR §880.6250 |
| Predicate Device1: | K153708<br>Halyard Black-Orange Powder-Free Nitrile Exam Glove |
| Predicate Device2: | K101596<br>Kimberly-Clark PURPLE NITRILE Powder-Free Exam Glove with Tested for<br>Use with Chemotherapy Drugs |

#### DEVICE DESCRIPTION

The Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate is a disposable, blackcolored on the grip side and orange colored on the donning side, nitrile, powder- free, textured fingertip, ambidextrous, non-sterile patient examination glove that are chlorinated on the donning side and are packed in a cardboard dispenser box.

The Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate is a disposable, 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 Halvard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

| | Subject Device1 K200633 | Predicate Device1 K153708 | Remarks |
|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | LZA, QDO | LZA | Different |
| Classification | Class 1 | Class 1 | Same |
| Trade Name | Halyard Black-Fire Powder-Free Nitrile | Halyard Black-Orange Powder-Free Nitrile | Similar |
| | Exam Glove tested for use with | Exam Glove | |
| | Fentanyl Citrate | | |
| Indications for Use | The Halyard Black-Fire Powder-Free<br>Nitrile Exam Glove tested for use with<br>Fentanyl Citrate is a disposable device<br>intended for medical purposes that is<br>worn on the examiner's hand to<br>prevent contamination between<br>patient and examiner.<br>The following drugs showed no<br>breakthrough at 240 minutes:<br>Fentanyl Citrate, 100 cg/2ml | The Halyard® Black-Orange Powder-Free<br>Nitrile Exam Glove is a disposable device<br>intended for medical purposes that is<br>worn on the examiner's hand to prevent<br>contamination between patient and<br>examiner. | Similar |
| Technological<br>Characteristics | Black on the grip side, orange on the<br>donning side, nitrile, powder-<br>free, textured fingertip, ambidextrous,<br>non- sterile patient examination glove. | Black on the grip side, orange on the<br>donning side, nitrile, powder-<br>free, textured fingertip, ambidextrous,<br>non- sterile patient examination glove. | Same |
| Sterilization | Gloves are supplied non-sterile | Gloves are supplied non-sterile | Same |
| ISO 10993-10<br>Biological evaluation of<br>medical devices -<br>Tests for Irritation | Acceptance criteria: No<br>erythema/edema up to 72 hours post<br>exposure. Result: Erythema/edema<br>was negligible. Meets acceptance<br>criteria. PASS | Acceptance criteria: No<br>erythema/edema up to 72 hours post<br>exposure. Result: Erythema/edema<br>was negligible. Meets acceptance<br>criteria. PASS | Same |
| ISO 10993-10<br>Biological evaluation of<br>medical devices -Tests<br>for Skin<br>Sensitization | Acceptance criteria: No evidence of<br>delayed dermal contact sensitivity at 24<br>and 48 hours post injection. Result: Not<br>a sensitizer under conditions of the<br>study. Meets acceptance criteria. PASS | Acceptance criteria: No evidence of<br>delayed dermal contact sensitivity at 24<br>and 48 hours post injection. Result: Not<br>a sensitizer under conditions of the<br>study. Meets acceptance criteria. PASS | Same |
| 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. Result: No systemic toxicity<br>observed. Meets acceptance criteria.<br>PASS | Acceptance criteria: No signs of systemic<br>toxicity up to 72 hours post injection.<br>Result: No systemic toxicity observed.<br>Meets acceptance criteria. PASS | Same |

# Table 1 comparison between the predicate Device 1 and subject Device 1

# Table 2 comparison between the predicate Device2 and subject Device2

| | Subject Device2<br>K200633 | Predicate Device2<br>K101596 | Remarks |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | LZC, QDO | LZC | Different |
| Classification | Class 1 | Class 1 | Same |
| Trade Name | Halyard Purple Nitrile Powder-Free<br>Exam Glove tested for use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate | Kimberly-Clark PURPLE Nitrile Powder-Free<br>Exam Glove with Tested for Use with<br>Chemotherapy Drugs Labeling Claim | Similar |
| Indications for Use | Halyard Purple Nitrile Powder-Free<br>Exam Glove tested for use with | A powder-free patient examination glove<br>is a disposable device intended for | Similar |
| | Chemotherapy Drugs and Fentanyl<br>Citrate is a disposable device intended<br>for medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient and<br>examiner. The following drugs showed<br>no breakthrough at 240 minutes:<br><br>Fentanyl Citrate, 100 cg/2ml<br>Bleomycin (15.0 mg/ml)<br>Busulfan (6.0 mg/ml)<br>Carboplatin (10.0 mg/ml)<br>Cisplatin (1.0 mg/ml)<br>Cyclophosphamide (20.0 mg/ml)<br>Cytarabine (100.0 mg/ml)<br>Dacarbazine (DTIC) (10.0 mg/ml)<br>Daunorubicin (5.0 mg/ml)<br>Docetaxel (10.0 mg/ml)<br>Doxorubicin Hydrochloride (2.0<br>mg/ml)<br>Ellence (2.0 mg/ml)<br>Etoposide (Toposar) (20.0 mg/ml)<br>Fludarabine (25.0 mg/ml)<br>Fluorouracil (50.0 mg/ml)<br>Gemcitabine (Gemzar) (38.0mg/ml)<br>Idarubicin (1.0 mg/ml)<br>Ifosfamide (50.0 mg/ml)<br>Irinotecan (20.0 mg/ml)<br>Mechlorethamine HCl (1.0 mg/ml)<br>Melphalan (5.0 mg/ml)<br>Methotrexate (25.0mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone (2.0mg/ml)<br>Paclitaxel (Taxol) (6.0 mg/ml)<br>Paraplatin (10.0 mg/ml)<br>Rituximab (10.0 mg/ml)<br>Trisonex (1.0 mg/ml)<br>Vincrinstine (1mg/ml)<br><br>The following drugs showed<br>breakthrough detected in less than 30<br>minutes:<br>Carmustine (3.3mg/ml): 1.8 minutes<br>ThioTEPA(10.0mg/ml) 1.7 minutes | medical purposes that is worn on the<br>examiners hand or finger to prevent<br>contamination between patient and<br>examiner.<br>In addition, these chemotherapy gloves<br>were tested for use with the following<br>drug concentrations per ASTMV D6978-<br>05:<br>The following drugs had no breakthrough<br>detected up to 240 minutes:<br>Bleomycin (15.0 mg/ml)<br>Busulfan (6.0 mg/ml)<br>Carboplatin (10.0 mg/ml)<br>Cisplatin (1.0 mg/ml)<br>Cyclophosphamide (20.0 mg/ml)<br>Cytarabine (100.0 mg/ml)<br>Dacarbazine (DTIC) (10.0 mg/ml)<br>Daunorubicin (5.0 mg/ml)<br>Docetaxel (10.0 mg/ml)<br>Doxorubicin Hydrochloride (2.0 mg/ml)<br>Ellence (2.0 mg/ml)<br>Etoposide (Toposar) (20.0 mg/ml)<br>Fludarabine (25.0 mg/ml)<br>Fluorouracil (50.0 mg/ml)<br>Gemcitabine (Gemzar) (38.0mg/ml)<br>Idarubicin (1.0 mg/ml)<br>Ifosfamide (50.0 mg/ml)<br>Irinotecan (20.0 mg/ml)<br>Mechlorethamine HCl (1.0 mg/ml)<br>Melphalan (5.0 mg/ml)<br>Methotrexate (25.0mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone (2.0mg/ml)<br>Paclitaxel (Taxol) (6.0 mg/ml)<br>Paraplatin (10.0 mg/ml)<br>Rituximab (10.0 mg/ml)<br>Trisonex (1.0 mg/ml)<br>Vincrinstine (1mg/ml)<br><br>The following drugs showed<br>breakthrough detected in less than 30<br>minutes:<br>Carmustine (3.3mg/ml): 1.8 minutes<br>ThioTEPA(10.0mg/ml) 1.7 minutes | |
| Technological<br>Characteristics | Purple nitrile, powder-free, textured<br>fingertip, ambidextrous, non-sterile<br>patient examination glove. | Purple nitrile, powder- free, textured<br>fingertip, ambidextrous, non-sterile<br>patient examination glove. | Similar |
| Sterilization | Gloves are supplied non- sterile | Gloves are supplied non- sterile | Same |
| ISO 10993-10<br>Biological evaluation of<br>medical devices -<br>Tests for Irritation | Acceptance criteria: No<br>erythema/edema up to 72 hours post<br>exposure. Result: Erythema/edema<br>was negligible. Meets acceptance<br>criteria PASS | Acceptance criteria: No<br>erythema/edema up to 72 hours post<br>exposure. Result: Erythema/edema was<br>negligible. Meets acceptance criteria.<br>PASS | Same |
| ISO 10993-10<br>Biological evaluation of<br>medical devices -Tests<br>for Skin<br>Sensitization | Acceptance criteria: No evidence of<br>delayed dermal contact sensitivity at<br>24 and 48 hours post injection. Result:<br>Not a sensitizer under conditions of<br>the study. Meets acceptance criteria.<br>PASS | Acceptance criteria: No evidence of<br>delayed dermal contact sensitivity at 24<br>and 48 hours post injection. Result: Not a<br>sensitizer under conditions of the study.<br>Meets acceptance criteria. PASS | Same |
| 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. Result: No systemic toxicity<br>observed. Meets acceptance criteria.<br>PASS | Acceptance criteria: No signs of systemic<br>toxicity up to 72 hours post injection.<br>Result: No systemic toxicity observed.<br>Meets acceptance criteria. PASS | Same |

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# SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

Subject Device1, Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate and subject Device2, Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate were both tested for conformance to the applicable sections of the following standards:

- ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D 6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- . ISO 10993-10 Biological evaluation of medical devices -Tests for Irritation and Skin Sensitization
- . ISO 10993-11 Biological evaluation of medical devices - Tests for Systemic Toxicity.

| Performance | K200633 | K153708 | Remarks |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| | Subject Device1 The Halyard Black-Fire<br>Powder-Free Nitrile Exam Glove tested<br>for use with Fentanyl Citrate | Predicate Device1 Halyard Black-Orange<br>Powder-Free Nitrile Exam Glove | |
| ASTM D5151-06<br>Standard Test<br>Method for<br>Detection of<br>Holes in Medical<br>Gloves | device shows it meets the 2.5 AQL<br>requirement in the standards for<br>leakage. The device meets the<br>acceptance criteria of the standard.<br>PASS | device shows it meets the 2.5 AQL<br>requirement in the standards for<br>leakage. The device meets the<br>acceptance criteria of the standard.<br>PASS | Same |
| ASTM D6319<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Applications | Properties | Test results | ASTM SPEC |
| | Holes | AQL 1.0% | AQL 2.5% |
| | Length | 230-258mm | >230mm |
| | Width | 85-105mm | 85-105mm |
| | Palm | .05-07mm | >.050mm |
| | Unaged<br>Tensile | >16MPa | >14MPa |
| | Unaged<br>Elongation | > 500% | > 500% |
| | Aged<br>Tensile | >15MPa | >14MPa |
| | Aged<br>Elongation | >450% | >400% |
| | Powder | <2mg/glove | <2mg/glove |
| | Properties | Test results | ASTM SPEC |
| | Holes | AQL 1.0% | AQL 2.5% |
| | Length | 230-258mm | >230mm |
| | Width | 85-105mm | 85-105mm |
| | Palm | .05-.07mm | >.050mm |
| | Unaged<br>Tensile | >16MPa | >14MPa |
| | Unaged<br>Elongation | > 500% | > 500% |
| | Aged<br>Tensile | >15MPa | >14MPa |
| | Aged<br>Elongation | >450% | >400% |
| | Powder | <2mg/glove | <2mg/glove |
| | Same | | |
| | | | Same |
| ASTM D 6978<br>Standard Practice for<br>Assessment of<br>Resistance of<br>Medical Gloves to | The following drugs showed no<br>breakthrough at 240 minutes:<br><br>Fentanyl Citrate, 100 mcg/2ml | Not applicable | Different,<br>adding<br>Fentanyl<br>Citrate |

### Table 3. Non-clinical performance testing for the subject Device1 compared to Predicate device 1

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| Permeation by | | | |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Chemotherapy Drugs | | | |
| ASTM D6124<br>Standard Test<br>Method for<br>Residual Powder on<br>Medical Gloves | Residual powder on the subject device is<br>within the powder-free limit of < 2 mg<br>maximum powder per glove and meets<br>the acceptance criteria for powder-free.<br>PASS | Residual powder on the subject device is<br>within the powder-free limit of < 2 mg<br>maximum powder per glove and meets<br>the acceptance criteria for powder-free.<br>PASS | Same |

# Table 4. Non-clinical Performance testing for the subject Device2 compared to Predicate device 2

| Performance | K200633 | K101596 | Remarks |
|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| | Subject Device2 Halyard Purple Nitrile<br>Powder-Free Exam Glove tested for use<br>with Chemotherapy Drugs and Fentanyl<br>Citrate | Predicate Device2 Kimberly-Clark PURPLE<br>Nitrile Powder-Free Exam Glove with<br>Tested for Use with Chemotherapy Drugs<br>Labeling Claim | |
| ASTM D5151-06<br>Standard Test<br>Method for<br>Detection of<br>Holes in Medical<br>Gloves | device shows it meets the 2.5 AQL<br>requirement in the standards for<br>leakage. The device meets the<br>acceptance criteria of the standard.<br>PASS | device shows it meets the 2.5 AQL<br>requirement in the standards for<br>leakage. The device meets the acceptance<br>criteria of the standard.<br>PASS | Same |
| ASTM D6319<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Applications | Properties | Test results | ASTM SPEC |
| | Holes | AQL 1.0% | AQL 2.5% |
| | Length | 230-258mm | >230mm |
| | Width | 85-105mm…