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.

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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for medical gloves. It describes the acceptance criteria and performance data for two devices:

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

The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove an AI model's performance. Therefore, many of the requested items related to AI/MRMC studies, expert adjudication, and ground truth establishment for AI models are not applicable to this document.

However, I can extract the acceptance criteria and device performance as reported for these specific medical devices based on the provided text.

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these gloves are primarily based on established ASTM and ISO standards for medical examination gloves. The performance data presented demonstrates that the subject devices meet these standards and are substantially equivalent to their predicate devices.

Device 1: Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate

Performance Metric	Acceptance Criteria (Standard)	Reported Device Performance
Biocompatibility (ISO 10993)
Irritation (ISO 10993-10)	No erythema/edema up to 72 hours post exposure	Erythema/edema was negligible. Meets acceptance criteria. (PASS)
Skin Sensitization (ISO 10993-10)	No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection	Not a sensitizer under conditions of the study. Meets acceptance criteria. (PASS)
Systemic Toxicity (ISO 10993-11)	No signs of systemic toxicity up to 72 hours post injection	No systemic toxicity observed. Meets acceptance criteria. (PASS)
Physical Properties (ASTM D6319-10)
Holes (AQL)	AQL 2.5%	AQL 1.0%. Meets the 2.5 AQL requirement for leakage. (PASS)
Length	>230mm	230-258mm
Width	85-105mm	85-105mm
Palm Thickness	>.050mm	.05-.07mm
Unaged Tensile Strength	>14MPa	>16MPa
Unaged Elongation	>500%	>500%
Aged Tensile Strength	>14MPa	>15MPa
Aged Elongation	>400%	>450%
Residual Powder (ASTM D6124-06)	<2mg/glove	<2mg/glove. Meets acceptance criteria for powder-free. (PASS)
Fentanyl Permeation (ASTM D 6978-05)	No breakthrough at 240 minutes for Fentanyl Citrate	Fentanyl Citrate, 100 mcg/2ml: No breakthrough at 240 minutes.

Device 2: Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate

Performance Metric	Acceptance Criteria (Standard)	Reported Device Performance
Biocompatibility (ISO 10993)
Irritation (ISO 10993-10)	No erythema/edema up to 72 hours post exposure	Erythema/edema was negligible. Meets acceptance criteria. (PASS)
Skin Sensitization (ISO 10993-10)	No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection	Not a sensitizer under conditions of the study. Meets acceptance criteria. (PASS)
Systemic Toxicity (ISO 10993-11)	No signs of systemic toxicity up to 72 hours post injection	No systemic toxicity observed. Meets acceptance criteria. (PASS)
Physical Properties (ASTM D6319-10)
Holes (AQL)	AQL 2.5%	AQL 1.0%. Meets the 2.5 AQL requirement for leakage. (PASS)
Length	>230mm	230-258mm
Width	85-105mm	85-105mm
Palm Thickness	>.050mm	.05-.07mm
Unaged Tensile Strength	>14MPa	>16MPa
Unaged Elongation	>500%	>500%
Aged Tensile Strength	>14MPa	>15MPa
Aged Elongation	>400%	>450%
Residual Powder (ASTM D6124-06)	<2mg/glove	<2mg/glove. Meets acceptance criteria for powder-free. (PASS)
Chemotherapy Drug Permeation (ASTM D 6978-05)	No breakthrough at 240 minutes for listed drugs. Breakthrough detected in less than 30 minutes for Carmustine and ThioTEPA.	No breakthrough at 240 minutes for: Fentanyl Citrate (100 mcg/2ml), 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) (38.0mg/ml), Idarubicin (1.0 mg/ml), Ifosfamide (50.0 mg/ml), Irinotecan (20.0 mg/ml), Mechlorethamine HCl (1.0 mg/ml), Melphalan (5.0 mg/ml), Methotrexate (25.0mg/ml), Mitomycin C (0.5 mg/ml), Mitoxantrone (2.0mg/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). Breakthrough detected for: Carmustine (3.3mg/ml): 1.8 minutes. ThioTEPA (10.0mg/ml): 1.7 minutes. (Warning: Not for use with Carmustine and ThioTEPA).

Study Information (as applicable to a medical device 510(k) for gloves)

Sample size used for the test set and the data provenance:
- The document implies that testing was done according to the specified ASTM and ISO standards for medical gloves. These standards define the sampling plans (e.g., AQL for holes). Specific sample sizes for each test are not explicitly detailed in this summary but are inherent to the referenced standards.
- Data Provenance: The tests would have been performed in a laboratory setting to evaluate the physical, chemical, and biocompatibility properties of the gloves. The country of origin of the data is not specified in the document, but it's generated by the manufacturer for regulatory submission in the U.S. (FDA). The nature of the data is quantitative and laboratory-based, not patient (retrospective or prospective) data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For medical gloves, "ground truth" is established by adherence to recognized performance standards (ASTM, ISO). These are engineering and material science tests, not clinical evaluations requiring human expert interpretation in the sense of an AI study (e.g., radiologists interpreting images). The manufacturers' internal quality control and external testing labs are responsible for verifying compliance with these standards.
Adjudication method for the test set:
- Not Applicable. Test results are objective measurements against established standard criteria, not subjective interpretations requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a filing for a physical medical device (gloves), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device evaluation is adherence to validated industry performance standards (ASTM, ISO) for physical properties, biocompatibility, and chemical permeation resistance. These standards are quantitative and objective.
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in the context of demonstrating equivalence for medical gloves. The manufacturing process and material formulations are continuously "trained" and refined during product development, but this is not data-driven training in the AI sense.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set in the AI sense.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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)

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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 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

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510(k) Summary

K200633

Date Summary was Prepared:	October 10, 2020
510(k) Submitter:	Steven DowdleyAssociate Director, Regulatory Affairs505 Windward ParkwayAlpharetta, GA 30004Email: steven.dowdley@hyh.comPhone: 678-451-8062
Primary Contact for this 510(k):	Same as above
Device1 Trade Name:	Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use withFentanyl Citrate
Device2 Trade Name:	Halyard Purple Nitrile Powder-Free Exam Glove tested for use withChemotherapy 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:	K153708Halyard Black-Orange Powder-Free Nitrile Exam Glove
Predicate Device2:	K101596Kimberly-Clark PURPLE NITRILE Powder-Free Exam Glove with Tested forUse with Chemotherapy Drugs

DEVICE DESCRIPTION

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-FreeNitrile Exam Glove tested for use withFentanyl Citrate is a disposable deviceintended for medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner.The following drugs showed nobreakthrough at 240 minutes:Fentanyl Citrate, 100 cg/2ml	The Halyard® Black-Orange Powder-FreeNitrile Exam Glove is a disposable deviceintended for medical purposes that isworn on the examiner's hand to preventcontamination between patient andexaminer.	Similar
TechnologicalCharacteristics	Black on the grip side, orange on thedonning side, nitrile, powder-free, textured fingertip, ambidextrous,non- sterile patient examination glove.	Black on the grip side, orange on thedonning side, nitrile, powder-free, textured fingertip, ambidextrous,non- sterile patient examination glove.	Same
Sterilization	Gloves are supplied non-sterile	Gloves are supplied non-sterile	Same
ISO 10993-10Biological evaluation ofmedical devices -Tests for Irritation	Acceptance criteria: Noerythema/edema up to 72 hours postexposure. Result: Erythema/edemawas negligible. Meets acceptancecriteria. PASS	Acceptance criteria: Noerythema/edema up to 72 hours postexposure. Result: Erythema/edemawas negligible. Meets acceptancecriteria. PASS	Same
ISO 10993-10Biological evaluation ofmedical devices -Testsfor SkinSensitization	Acceptance criteria: No evidence ofdelayed dermal contact sensitivity at 24and 48 hours post injection. Result: Nota sensitizer under conditions of thestudy. Meets acceptance criteria. PASS	Acceptance criteria: No evidence ofdelayed dermal contact sensitivity at 24and 48 hours post injection. Result: Nota sensitizer under conditions of thestudy. Meets acceptance criteria. PASS	Same
ISO 10993 Biologicalevaluation of medicaldevices - Tests forSystemic Toxicity	Acceptance criteria: No signs ofsystemic toxicity up to 72 hours postinjection. Result: No systemic toxicityobserved. Meets acceptance criteria.PASS	Acceptance criteria: No signs of systemictoxicity up to 72 hours post injection.Result: No systemic toxicity observed.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 Device2K200633	Predicate Device2K101596	Remarks
Product Code	LZC, QDO	LZC	Different
Classification	Class 1	Class 1	Same
Trade Name	Halyard Purple Nitrile Powder-FreeExam Glove tested for use withChemotherapy Drugs and FentanylCitrate	Kimberly-Clark PURPLE Nitrile Powder-FreeExam Glove with Tested for Use withChemotherapy Drugs Labeling Claim	Similar
Indications for Use	Halyard Purple Nitrile Powder-FreeExam Glove tested for use with	A powder-free patient examination gloveis a disposable device intended for	Similar
	Chemotherapy Drugs and FentanylCitrate is a disposable device intendedfor medical purposes that is worn onthe examiner's hand to preventcontamination between patient andexaminer. The following drugs showedno breakthrough at 240 minutes:Fentanyl Citrate, 100 cg/2mlBleomycin (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 (2.0mg/ml)Ellence (2.0 mg/ml)Etoposide (Toposar) (20.0 mg/ml)Fludarabine (25.0 mg/ml)Fluorouracil (50.0 mg/ml)Gemcitabine (Gemzar) (38.0mg/ml)Idarubicin (1.0 mg/ml)Ifosfamide (50.0 mg/ml)Irinotecan (20.0 mg/ml)Mechlorethamine HCl (1.0 mg/ml)Melphalan (5.0 mg/ml)Methotrexate (25.0mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2.0mg/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)The following drugs showedbreakthrough detected in less than 30minutes:Carmustine (3.3mg/ml): 1.8 minutesThioTEPA(10.0mg/ml) 1.7 minutes	medical purposes that is worn on theexaminers hand or finger to preventcontamination between patient andexaminer.In addition, these chemotherapy gloveswere tested for use with the followingdrug concentrations per ASTMV D6978-05:The following drugs had no breakthroughdetected up to 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) (38.0mg/ml)Idarubicin (1.0 mg/ml)Ifosfamide (50.0 mg/ml)Irinotecan (20.0 mg/ml)Mechlorethamine HCl (1.0 mg/ml)Melphalan (5.0 mg/ml)Methotrexate (25.0mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2.0mg/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)The following drugs showedbreakthrough detected in less than 30minutes:Carmustine (3.3mg/ml): 1.8 minutesThioTEPA(10.0mg/ml) 1.7 minutes
TechnologicalCharacteristics	Purple nitrile, powder-free, texturedfingertip, ambidextrous, non-sterilepatient examination glove.	Purple nitrile, powder- free, texturedfingertip, ambidextrous, non-sterilepatient examination glove.	Similar
Sterilization	Gloves are supplied non- sterile	Gloves are supplied non- sterile	Same
ISO 10993-10Biological evaluation ofmedical devices -Tests for Irritation	Acceptance criteria: Noerythema/edema up to 72 hours postexposure. Result: Erythema/edemawas negligible. Meets acceptancecriteria PASS	Acceptance criteria: Noerythema/edema up to 72 hours postexposure. Result: Erythema/edema wasnegligible. Meets acceptance criteria.PASS	Same
ISO 10993-10Biological evaluation ofmedical devices -Testsfor SkinSensitization	Acceptance criteria: No evidence ofdelayed dermal contact sensitivity at24 and 48 hours post injection. Result:Not a sensitizer under conditions ofthe study. Meets acceptance criteria.PASS	Acceptance criteria: No evidence ofdelayed dermal contact sensitivity at 24and 48 hours post injection. Result: Not asensitizer under conditions of the study.Meets acceptance criteria. PASS	Same
ISO 10993 Biologicalevaluation of medicaldevices - Tests forSystemic Toxicity	Acceptance criteria: No signs ofsystemic toxicity up to 72 hours postinjection. Result: No systemic toxicityobserved. Meets acceptance criteria.PASS	Acceptance criteria: No signs of systemictoxicity up to 72 hours post injection.Result: No systemic toxicity observed.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-FirePowder-Free Nitrile Exam Glove testedfor use with Fentanyl Citrate	Predicate Device1 Halyard Black-OrangePowder-Free Nitrile Exam Glove
ASTM D5151-06Standard TestMethod forDetection ofHoles in MedicalGloves	device shows it meets the 2.5 AQLrequirement in the standards forleakage. The device meets theacceptance criteria of the standard.PASS	device shows it meets the 2.5 AQLrequirement in the standards forleakage. The device meets theacceptance criteria of the standard.PASS	Same
ASTM D6319StandardSpecification forNitrile ExaminationGloves for MedicalApplications	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
	UnagedTensile	>16MPa	>14MPa
	UnagedElongation	> 500%	> 500%
	AgedTensile	>15MPa	>14MPa
	AgedElongation	>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
	UnagedTensile	>16MPa	>14MPa
	UnagedElongation	> 500%	> 500%
	AgedTensile	>15MPa	>14MPa
	AgedElongation	>450%	>400%
	Powder	<2mg/glove	<2mg/glove
	Same
			Same
ASTM D 6978Standard Practice forAssessment ofResistance ofMedical Gloves to	The following drugs showed nobreakthrough at 240 minutes:Fentanyl Citrate, 100 mcg/2ml	Not applicable	Different,addingFentanylCitrate

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

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Permeation by
Chemotherapy Drugs
ASTM D6124Standard TestMethod forResidual Powder onMedical Gloves	Residual powder on the subject device iswithin the powder-free limit of < 2 mgmaximum powder per glove and meetsthe acceptance criteria for powder-free.PASS	Residual powder on the subject device iswithin the powder-free limit of < 2 mgmaximum powder per glove and meetsthe acceptance criteria for powder-free.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 NitrilePowder-Free Exam Glove tested for usewith Chemotherapy Drugs and FentanylCitrate	Predicate Device2 Kimberly-Clark PURPLENitrile Powder-Free Exam Glove withTested for Use with Chemotherapy DrugsLabeling Claim
ASTM D5151-06Standard TestMethod forDetection ofHoles in MedicalGloves	device shows it meets the 2.5 AQLrequirement in the standards forleakage. The device meets theacceptance criteria of the standard.PASS	device shows it meets the 2.5 AQLrequirement in the standards forleakage. The device meets the acceptancecriteria of the standard.PASS	Same
ASTM D6319StandardSpecification forNitrile ExaminationGloves for MedicalApplications	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
	UnagedTensile	>16MPa	>14MPa
	UnagedElongation	> 500%	> 500%
	AgedTensile	>15MPa	>14MPa
	AgedElongation	>450%	>400%
	Powder	<2mg/glove	<2mg/glove
ASTM D 6978Standard Practicefor Assessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs	The following drugs showed nobreakthrough at 240 minutes:Fentanyl Citrate, 100 cg/2mlBleomycin (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) DoxorubicinHydrochloride (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	The following drugs showed nobreakthrough 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) DoxorubicinHydrochloride (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)	Similar,addingFentanylCitrate
	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
	UnagedTensile	>16MPa	>14MPa
	UnagedElongation	> 500%	> 500%
	AgedTensile	>15Ma	>14MPa
	AgedElongation	>450%	>400%
	Powder	<2mg/glove	<2mg/glove
	The following drugs showed nobreakthrough at 240 minutes:Fentanyl Citrate, 100 cg/2mlBleomycin (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) DoxorubicinHydrochloride (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	The following drugs showed nobreakthrough 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) DoxorubicinHydrochloride (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)
	(Gemzar) (38.0mg/ml)Idarubicin (1.0 mg/ml)Ifosfamide (50.0 mg/ml)Irinotecan (20.0 mg/ml)Mechlorethamine HCl (1.0 mg/ml)Melphalan (5.0 mg/ml)Methotrexate (25.0mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2.0mg/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)	Ifosfamide (50.0 mg/ml)Irinotecan (20.0 mg/ml)Mechlorethamine HCl (1.0 mg/ml)Melphalan (5.0 mg/ml)Methotrexate (25.0 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2.0mg/ml)Paclitaxel (Taxol) (6.0mg/ml)Paraplatin (10.0 mg/ml)Rituximab (10.0 mg/ml)Trisonex (1.0 mg/ml)Vincrinstine (1mg/ml)
ASTM D6124Standard TestMethod forResidual Powder onMedical Gloves	Residual powder on the subject deviceis within the powder-free limit of < 2 mgmaximum powder per glove and meetsthe acceptance criteria for powder-free.PASS	Residual powder on the subject device iswithin the powder-free limit of < 2 mgmaximum powder per glove and meets theacceptance criteria for powder-free. PASS	Same

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CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject in 510(K) submission K200633, the Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153708;

The conclusion drawn from the nonclinical tests demonstrates that the subject Device2 in 510(K) submission K200633, Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K101596.

Regulation Number and Section

§ 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.