(215 days)
Not Found
No
The device is a disposable exam glove and the summary does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device is described as an "exam glove" intended to prevent contamination between the patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device is an exam glove, intended to prevent contamination between patient and examiner. It does not gather any information about the patient's health or condition, which is a characteristic of diagnostic devices.
No
The device described is a physical medical device (exam gloves) and does not involve any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics of a glove, not a device designed for in vitro testing.
- Performance Studies: The performance studies focus on the physical properties of the glove (leakage, tensile strength, elongation, powder content) and its barrier properties against certain drugs. These are relevant to a protective glove, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
Therefore, the Halyard Black Fire and Purple Nitrile Exam Gloves described are medical devices, specifically examination gloves, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, QDO, LZC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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)
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.
Key results from performance tests:
- ASTM D5151-06: both devices meet the 2.5 AQL requirement for leakage.
- ASTM D6319-10: both devices meet the specification for holes (AQL 1.0%), length (>230mm), width (85-105mm), palm thickness (>.050mm), unaged tensile (>14MPa), unaged elongation (> 500%), aged tensile (>14MPa), aged elongation (>400%), and powder (
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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.
4
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 PRAStaff@fda.hhs.qov
"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."
5
510(k) Summary
K200633
| Date Summary was Prepared: | October 10, 2020 |
|---|---|
| 510(k) Submitter: | Steven Dowdley |
| Associate Director, Regulatory Affairs | |
| 505 Windward Parkway | |
| Alpharetta, GA 30004 | |
| Email: steven.dowdley@hyh.com | |
| Phone: 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 with |
| Fentanyl Citrate | |
| Device2 Trade Name: | Halyard Purple Nitrile Powder-Free Exam Glove tested for use with |
| 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 |
| Halyard Black-Orange Powder-Free Nitrile Exam Glove | |
| Predicate Device2: | K101596 |
| Kimberly-Clark PURPLE NITRILE Powder-Free Exam Glove with Tested for | |
| 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.
6
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 | ||
| 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 following drugs showed no | |||
| breakthrough at 240 minutes: | |||
| Fentanyl Citrate, 100 cg/2ml | 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. | Similar | ||
| Technological | |||
| Characteristics | Black on the grip side, orange on the | ||
| donning side, nitrile, powder- | |||
| free, textured fingertip, ambidextrous, | |||
| non- sterile patient examination glove. | Black on the grip side, orange on the | ||
| donning 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 10993-10 | |||
| Biological evaluation of | |||
| medical devices - | |||
| Tests for Irritation | Acceptance criteria: No | ||
| erythema/edema up to 72 hours post | |||
| exposure. Result: Erythema/edema | |||
| was negligible. Meets acceptance | |||
| criteria. PASS | Acceptance criteria: No | ||
| erythema/edema up to 72 hours post | |||
| exposure. Result: Erythema/edema | |||
| was negligible. Meets acceptance | |||
| criteria. PASS | Same | ||
| ISO 10993-10 | |||
| Biological evaluation of | |||
| medical devices -Tests | |||
| for Skin | |||
| Sensitization | Acceptance criteria: No evidence of | ||
| delayed dermal contact sensitivity at 24 | |||
| and 48 hours post injection. Result: Not | |||
| a sensitizer under conditions of the | |||
| study. Meets acceptance criteria. PASS | Acceptance criteria: No evidence of | ||
| delayed dermal contact sensitivity at 24 | |||
| and 48 hours post injection. Result: Not | |||
| a sensitizer under conditions of the | |||
| study. Meets acceptance criteria. PASS | Same | ||
| ISO 10993 Biological | |||
| evaluation of medical | |||
| devices - Tests for | |||
| Systemic Toxicity | Acceptance criteria: No signs of | ||
| systemic toxicity up to 72 hours post | |||
| injection. Result: No systemic toxicity | |||
| observed. Meets acceptance criteria. | |||
| PASS | Acceptance criteria: No signs of systemic | ||
| toxicity 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 Device2
K200633 | Predicate Device2
K101596 | Remarks |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | LZC, QDO | LZC | Different |
| Classification | Class 1 | Class 1 | Same |
| Trade Name | Halyard Purple Nitrile Powder-Free
Exam Glove tested for use with
Chemotherapy Drugs and Fentanyl
Citrate | Kimberly-Clark PURPLE Nitrile Powder-Free
Exam Glove with Tested for Use with
Chemotherapy Drugs Labeling Claim | Similar |
| Indications for Use | Halyard Purple Nitrile Powder-Free
Exam Glove tested for use with | A powder-free patient examination glove
is a disposable device intended for | Similar |
| | 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
no breakthrough at 240 minutes:
Fentanyl Citrate, 100 cg/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)
The following drugs showed
breakthrough detected in less than 30
minutes:
Carmustine (3.3mg/ml): 1.8 minutes
ThioTEPA(10.0mg/ml) 1.7 minutes | medical purposes that is worn on the
examiners hand or finger to prevent
contamination between patient and
examiner.
In addition, these chemotherapy gloves
were tested for use with the following
drug concentrations per ASTMV D6978-
05:
The following drugs had no breakthrough
detected 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 showed
breakthrough detected in less than 30
minutes:
Carmustine (3.3mg/ml): 1.8 minutes
ThioTEPA(10.0mg/ml) 1.7 minutes | |
| Technological
Characteristics | Purple nitrile, powder-free, textured
fingertip, ambidextrous, non-sterile
patient examination glove. | Purple nitrile, powder- free, textured
fingertip, ambidextrous, non-sterile
patient examination glove. | Similar |
| Sterilization | Gloves are supplied non- sterile | Gloves are supplied non- sterile | Same |
| ISO 10993-10
Biological evaluation of
medical devices -
Tests for Irritation | Acceptance criteria: No
erythema/edema up to 72 hours post
exposure. Result: Erythema/edema
was negligible. Meets acceptance
criteria PASS | Acceptance criteria: No
erythema/edema up to 72 hours post
exposure. Result: Erythema/edema was
negligible. Meets acceptance criteria.
PASS | Same |
| ISO 10993-10
Biological evaluation of
medical devices -Tests
for Skin
Sensitization | Acceptance criteria: No evidence of
delayed dermal contact sensitivity at
24 and 48 hours post injection. Result:
Not a sensitizer under conditions of
the study. Meets acceptance criteria.
PASS | Acceptance criteria: No evidence of
delayed dermal contact sensitivity at 24
and 48 hours post injection. Result: Not a
sensitizer under conditions of the study.
Meets acceptance criteria. PASS | Same |
| ISO 10993 Biological
evaluation of medical
devices - Tests for
Systemic Toxicity | Acceptance criteria: No signs of
systemic toxicity up to 72 hours post
injection. Result: No systemic toxicity
observed. Meets acceptance criteria.
PASS | Acceptance criteria: No signs of systemic
toxicity up to 72 hours post injection.
Result: No systemic toxicity observed.
Meets acceptance criteria. PASS | Same |
7
8
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 | |||
| Powder-Free Nitrile Exam Glove tested | |||
| for use with Fentanyl Citrate | Predicate Device1 Halyard Black-Orange | ||
| Powder-Free Nitrile Exam Glove | |||
| ASTM D5151-06 | |||
| Standard Test | |||
| Method for | |||
| Detection of | |||
| Holes in Medical | |||
| Gloves | device shows it meets the 2.5 AQL | ||
| requirement in the standards for | |||
| leakage. The device meets the | |||
| acceptance criteria of the standard. | |||
| PASS | device shows it meets the 2.5 AQL | ||
| requirement in the standards for | |||
| leakage. The device meets the | |||
| acceptance criteria of the standard. | |||
| PASS | Same | ||
| ASTM D6319 | |||
| Standard | |||
| Specification for | |||
| Nitrile Examination | |||
| Gloves for Medical | |||
| 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 | |||
| Tensile | >16MPa | >14MPa | |
| Unaged | |||
| Elongation | > 500% | > 500% | |
| Aged | |||
| Tensile | >15MPa | >14MPa | |
| Aged | |||
| Elongation | >450% | >400% | |
| Powder | 230mm | ||
| Width | 85-105mm | 85-105mm | |
| Palm | .05-.07mm | >.050mm | |
| Unaged | |||
| Tensile | >16MPa | >14MPa | |
| Unaged | |||
| Elongation | > 500% | > 500% | |
| Aged | |||
| Tensile | >15MPa | >14MPa | |
| Aged | |||
| Elongation | >450% | >400% | |
| Powder | 230mm | ||
| Width | 85-105mm | 85-105mm | |
| Palm | .05-.07mm | >.050mm | |
| Unaged | |||
| Tensile | >16MPa | >14MPa | |
| Unaged | |||
| Elongation | > 500% | > 500% | |
| Aged | |||
| Tensile | >15MPa | >14MPa | |
| Aged | |||
| Elongation | >450% | >400% | |
| Powder | 230mm | ||
| Width | 85-105mm | 85-105mm | |
| Palm | .05-.07mm | >.050mm | |
| Unaged | |||
| Tensile | >16MPa | >14MPa | |
| Unaged | |||
| Elongation | > 500% | > 500% | |
| Aged | |||
| Tensile | >15Ma | >14MPa | |
| Aged | |||
| Elongation | >450% | >400% | |
| Powder |