(176 days)
HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes.
HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12" disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that have been tested for use with chemotherapy drugs.
The provided text describes the acceptance criteria and performance data for HALYARD PURPLE NITRILE – XTRA Powder-Free Exam Gloves**, specifically regarding their resistance to chemotherapy drugs and other physical properties.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6978-05: Resistance to Permeation by Chemotherapy Drugs | No signs of breakthrough after 4 hours (>240 minutes) for most drugs. Specific breakthrough time for Carmustine set at 30.7 minutes for predicate device. | No breakthrough observed for most chemotherapy drugs up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes (at 3.3 mg/ml concentration). This exceeds the predicate's Carmustine breakthrough time of 30.7 minutes, indicating improved performance. |
| ASTM D5151-06: Detection of Holes in Medical Gloves | 2.5% AQL (Acceptable Quality Level) for leakage. | Meets the 2.5% AQL requirement. (Halyard Specification: AQL 1.0%) |
| ASTM D6124-06: Residual Powder on Medical Gloves | < 2 mg maximum powder per glove (powder-free limit). | Residual powder is within the powder-free limit of < 2 mg/glove. |
| ASTM D6319-10: Nitrile Examination Gloves for Medical Applications (Physical Dimensions & Properties) | Physical Dimensions:- Length: ≥ 230 mm- Width: 85-105 mm- Finger Thickness: ≥ 0.05 mm- Palm Thickness: ≥ 0.05 mmPhysical Properties:- Unaged Tensile: ≥ 14 MPa- Unaged Elongation: ≥ 500%- Aged Tensile: ≥ 14 MPa- Aged Elongation: ≥ 400% | Physical Dimensions:- Length: 295-325 mm- Width: 85-105 mm- Finger Thickness: 0.11-0.19 mm- Palm Thickness: 0.11-0.16 mmPhysical Properties:- Unaged Tensile: ≥ 14 MPa- Unaged Elongation: ≥ 500%- Aged Tensile: ≥ 14 MPa- Aged Elongation: ≥ 500% (All conform to or exceed ASTM D6319) |
| ISO 10993-10: Tests for Irritation | No erythema/edema up to 72 hours post exposure (for predicate device). | Based on an evaluation according to ISO 10993-1, no additional testing on the subject glove was needed as it was deemed substantially equivalent to the predicate which met this criterion with negligible erythema/edema. |
| ISO 10993-10: Tests for Skin Sensitization | No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection (for predicate device). | Based on an evaluation according to ISO 10993-1, no additional testing on the subject glove was needed as it was deemed substantially equivalent to the predicate which met this criterion (not a sensitizer). |
| ISO 10993-11: Tests for Systemic Toxicity | No signs of systemic toxicity up to 72 hours post injection (for predicate device). | Based on an evaluation according to ISO 10993-1, no additional testing on the subject glove was needed as it was deemed substantially equivalent to the predicate which met this criterion (no systemic toxicity observed). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for permeation, holes, etc.). However, it refers to industry standards (ASTM, ISO) which typically include defined sampling plans.
- Data Provenance: The testing was conducted by Halyard Health, an American company. The data is retrospective, as it was submitted for a 510(k) premarket notification to demonstrate substantial equivalence to an already marketed device. The specific country of origin for the raw test data is not stated but would presumably be the testing labs contracted by Halyard Health.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" here is based on objective, standardized laboratory tests according to ASTM and ISO standards, not expert interpretation of medical images or clinical outcomes. The results are quantitative measurements (e.g., breakthrough time, physical dimensions, AQL values) determined by laboratory protocols.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the tests are objective, standardized laboratory measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This is not applicable. This is a study on the physical and chemical barrier properties of medical gloves, not an AI-based diagnostic device requiring MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. This is a physical medical device (gloves), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" is established through standardized laboratory testing and measurements based on widely accepted international and national standards (ASTM D6978-05, ASTM D5151-06, ASTM D6124-06, ASTM D6319-10, ISO 10993-10, ISO 10993-11). These standards define the methodologies for assessing properties like chemical permeation, presence of holes, residual powder, and physical characteristics.
8. The Sample Size for the Training Set
This is not applicable. This is a physical device being tested against established performance standards, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
Haylard Health Gwendolyn George Regulatory Affairs, Technical Leader 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K160709 Trade/Device Name: HAYLARD* PURPLE NITRILE – XTRA* Powder Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: August 3, 2016 Received: August 4, 2016
Dear Ms. Gwendolyn George:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michae DVRyan -S
for Tina Kiang, Ph.D.
Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160709
Device Name
HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves
Indications for Use (Describe)
HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes
| ChemoTherapyDrug (conc.) | Break-throughTime (mins) | ChemoTherapyDrug (conc.) | Break-throughTime (mins) | ChemoTherapyDrug (conc.) | Break-throughTime (mins) |
|---|---|---|---|---|---|
| Arsenic Trioxide(1 mg/ml) | > 240 | Doxorubicin HCI(2 mg/ml) | > 240 | Paraplatin(10 mg/ml) | > 240 |
| Azacitidine (Vidaza)(25 mg/ml) | > 240 | Ellence(2 mg/ml) | > 240 | Pemetrexed(25 mg/ml) | > 240 |
| Bendamustine(5 mg/ml) | > 240 | Eribulin Mesylate(0.5 mg/ml) | > 240 | Pertuzumab(30 mg/ml) | > 240 |
| Bleomycin sulfate(15 mg/ml) | > 240 | Etoposid(20 mg/ml) | > 240 | Raltitrexed(0.5 mg/ml) | > 240 |
| Bortezomib (Velcade)(1 mg/ml) | > 240 | Fludarabine(25 mg/ml) | > 240 | Retrovir(10 mg/ml) | > 240 |
| Busulfan(6 mg/ml) | > 240 | Fulvestrant(50 mg/ml) | > 240 | Rituximab(10 mg/ml) | > 240 |
| Carfilzomib(2 mg/ml) | > 240 | Fluorouracil(50 mg/ml) | > 240 | Temsirolimus(25 mg/ml) | > 240 |
| Carboplatin(10 mg/ml) | > 240 | Gemcitabine(38 mg/ml) | > 240 | ThioTEPA(10 mg/ml) | > 240 |
| Carmustine(3.3 mg/ml) | 80.4 | Idarubicin(1 mg/ml) | > 240 | Topotean HCI(1 mg/ml) | > 240 |
| Cetuximab (Erbitux)(2 mg/ml) | > 240 | Ifosfamide(50 mg/ml) | > 240 | Trastuzumab(21 mg/ml) | > 240 |
| Cisplatin(1 mg/ml) | > 240 | Irinotecan(20 mg/ml) | > 240 | Triclosan(1 mg/ml) | > 240 |
| Cyclophosphamide(20 mg/ml) | > 240 | MechlorethamineHCl (1 mg/ml) | > 240 | Trisenox(0.1 mg/ml) | > 240 |
| Cytarabine HCI(100 mg/ml) | > 240 | Melphalan(5 mg/ml) | > 240 | Vinblastine(1 mg/ml) | > 240 |
| Cytovene(10 mg/ml) | > 240 | Methotrexate(25 mg/ml) | > 240 | Vincrinstine Sulfate(1 mg/ml) | > 240 |
| Dacarbazine(10 mg/ml) | > 240 | Mitomycin(0.5 mg/ml) | > 240 | Vinorelbine(10 mg/ml) | > 240 |
| Daunorubicin Hcl(5 mg/ml) | > 240 | Mitoxantrone(2 mg/ml) | > 240 | Zoledronic Acid(0.8 mg/ml) | > 240 |
| Decitabine(5 mg/ml) | > 240 | Oxaliplatin(2mg/ml) | > 240 | ||
| Docetaxel(10 mg/ml) | > 240 | Paclitaxel(6 mg/ml) | > 240 |
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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510(k) Summary
| Date Summarywas Prepared: | September 6, 2016 |
|---|---|
| 510(k) Submitter: | Gwendolyn GeorgeTechnical Leader, Regulatory AffairsHalyard Health5405 Windward ParkwayAlpharetta, GA 30004Email: Gwendolyn.George@hyh.comPh: 520-204-6442Establishment Registration Number 3011270181 |
| Primary Contact forthis 510(k)Submission: | Gwendolyn GeorgeTechnical Leader, Regulatory AffairsHalyard Health5405 Windward ParkwayAlpharetta, GA 30004Email: Gwendolyn.George@hyh.comPh: 520-204-6442 |
| Device Trade Name: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves |
| Device CommonName: | Medical Exam Gloves |
| Device Product Codeand ClassificationName: | LZCClass I, 21 CFR §880.6250Patient Examination Glove, Specialty |
| Predicate Device: | K113423Kimberly-Clark PURPLE NITRILE –XTRA* Powder-Free Exam Glove testedfor use with chemotherapy drugs - 12" Length |
| Subject DeviceDescription: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12"disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous,non-sterile patient examination gloves that have been tested for use withchemotherapy drugs. |
| Intended Use: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves tested foruse with Chemotherapy Drugs are powder-free patient examination gloves thatare a disposable device intended for medical purposes worn on the examiner'shand or finger to prevent contamination between patient and examiner. This isan over the counter medical device. The HALYARD* PURPLE NITRILE –XTRA* Powder-Free Exam Gloves have been tested with the followingChemotherapy drugs showing no breakthrough up to 240 minutes. Carmustineshowed break through at 80.4 minutes. |
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Halyard Health 510(k) for the HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves`
| Break-throughTime(mins) | ChemoTherapyDrug (conc.) | Break-throughTime(mins) | ChemoTherapyDrug (conc) | Break-throughTime(mins) | |
|---|---|---|---|---|---|
| ChemoTherapyDrug (conc.) | |||||
| Arsenic Trioxide(1 mg/ml) | > 240 | Doxorubicin HCI(2 mg/ml) | > 240 | Paraplatin(10 mg/ml) | > 240 |
| Azacitidine(Vidaza) (25mg/ml) | > 240 | Ellence(2 mg/ml) | > 240 | Pemetrexed(25 mg/ml) | > 240 |
| Bendamustine(5 mg/ml) | > 240 | Eribulin Mesylate(0.5 mg/ml) | > 240 | Pertuzumab(30 mg/ml) | > 240 |
| Bleomycin sulfate(15 mg/ml) | > 240 | Etoposid(20 mg/ml) | > 240 | Raltitrexed(0.5 mg/ml) | > 240 |
| Bortezomib(Velcade) (1mg/ml) | > 240 | Fludarabine(25 mg/ml) | > 240 | Retrovir(10 mg/ml) | > 240 |
| Busulfan(6 mg/ml) | > 240 | Fulvestrant(50 mg/ml) | > 240 | Rituximab(10 mg/ml) | > 240 |
| Carfilzomib(2 mg/ml) | > 240 | Fluorouracil(50 mg/ml) | > 240 | Temsirolimus(25 mg/ml) | > 240 |
| Carboplatin(10 mg/ml) | > 240 | Gemcitabine(38 mg/ml) | > 240 | ThioTEPA(10 mg/ml) | > 240 |
| Carmustine(3.3 mg/ml) | 80.4 | Idarubicin(1 mg/ml) | > 240 | Topotean HCl(1 mg/ml) | > 240 |
| Cetuximab(Erbitux)(2 mg/ml) | > 240 | Ifosfamide(50 mg/ml) | > 240 | Trastuzumab(21 mg/ml) | > 240 |
| Cisplatin(1 mg/ml) | > 240 | Irinotecan(20 mg/ml) | > 240 | Triclosan(1 mg/ml) | > 240 |
| Cyclophosphamide(20 mg/ml) | > 240 | MechlorethamineHCl (1 mg/ml) | > 240 | Trisenox(0.1 mg/ml) | > 240 |
| Cytarabine HCI(100 mg/ml) | > 240 | Melphalan(5 mg/ml) | > 240 | Vinblastine(1 mg/ml) | > 240 |
| Cytovene(10 mg/ml) | > 240 | Methotrexate(25 mg/ml) | > 240 | VincrinstineSulfate (1mg/ml) | > 240 |
| Dacarbazine(10 mg/ml) | > 240 | Mitomycin(0.5 mg/ml) | > 240 | Vinorelbine(10 mg/ml) | > 240 |
| Daunorubicin Hcl(5 mg/ml) | > 240 | Mitoxantrone(2 mg/ml) | > 240 | ZoledronicAcid(0.8 mg/ml) | > 240 |
| Decitabine(5 mg/ml) | > 240 | Oxaliplatin(2mg/ml) | > 240 | ||
| Docetaxel(10 mg/ml) | > 240 | Paclitaxel(6 mg/ml) | > 240 |
(Note within 510(k) Summary only: The difference between the subject and predicate devices' indications for use do not affect substantial equivalence.)
Summary of Technologies: The technological characteristics and intended use of the subject and predicate device are substantially equivalent. The subject device is increased in thickness. This change resulted in improved Carmustine permeation time of 80.4 minutes at a 3.3 mg/ml concentration and expanded chemotherapy drug resistance claim to 23 additional drugs as reflected in the table below.
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| F | Subject Device | Predicate DeviceK113423 | SubstantiallyEquivalent |
|---|---|---|---|
| FDA Product Code | LZC | LZC | Yes |
| FDA Classification | Class 1 | Class 1 | Yes |
| Common Name | Medical Exam Glove | Medical Exam Glove | Yes |
| Device Trade Name | HALYARD* PURPLE NITRILE -XTRA* Powder-Free Exam Gloves | Kimberly-Clark Purple Nitrile-XTRAPowder-Free Exam Gloves - 12"Length | Yes |
| Intended Use | HALYARD* PURPLE NITRILE -XTRA* Powder-Free Exam Glovesare 12" in length, a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand and finger toprevent contamination betweenpatient and examiner. | The Kimberly-Clark Purple Nitrile-XTRA Powder-Free Exam Glovetested for use with chemotherapydrugs -12" Length is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. | Yes |
| TechnologicalCharacteristics | Purple colored, chlorinated, nitrile,powder-free, textured fingertip,ambidextrous, non - sterile patientexamination glove. | Purple colored, chlorinated, nitrile,powder-free, textured fingertip,ambidextrous, non- sterile patientexamination glove. | Yes |
| Performance Data | |||
| ASTM D6978-05Standard Practice forAssessment ofResistance of MedicalGloves to Permeation byChemotherapy Drugs | Acceptance criteria: No signs ofbreakthrough after 4 hours.Carmustine showed no signs ofbreakthrough after 80.4 minutesResult: No breakthrough observed.Meets acceptance criteria. PASS | Acceptance criteria: No signs ofbreakthrough after 4 hours.Carmustine showed no signs ofbreakthrough after 30.7 minutesResult: No breakthrough observed.Meets acceptance criteria. PASS | Yes |
| ASTM D5151-06Standard Test Methodfor Detection of Holesin Medical Gloves | Testing of the subject device showsit meets the 2.5% AQL requirementin the standards for leakage. Thedevice meets the acceptance criteriaof the standard. PASS | Testing of the subject device shows itmeets the 2.5% AQL requirement inthe standards for leakage. The devicemeets the acceptance criteria of thestandard. PASS | Yes |
| ASTM D6124-06Standard Test Methodfor Residual Powder onMedical Gloves | Residual powder on the subjectdevice is within the powder-freelimit of < 2 mg maximum powderper glove and meets theacceptance criteria for powder-free. PASS | Residual powder on the subjectdevice is within the powder-freelimit of < 2 mg maximum powderper glove and meets theacceptance criteria for powder-free.PASS | Yes |
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| Subject Device | Predicate DeviceK113423 | SubstantiallyEquivalent | |||||
|---|---|---|---|---|---|---|---|
| Performance DataASTM D6319-10Standard Specificationfor Nitrile ExaminationGloves for MedicalApplications | The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject devicemeet the requirements for tensilestrength and elongation in thestandard. Therefore the devicemeets the acceptance criteria ofthe standard. PASS | The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject devicemeet the requirements for tensilestrength and elongation in thestandard. Therefore the devicemeets the acceptance criteria of thestandard. PASS | Yes | ||||
| Property | ASTM | HalyardSpecification | Property | ASTM | Kimberly ClarkSpecification | ||
| Holes | AQL 2.5% | AQL 1.0% | Holes | AQL 2.5% | AQL 1.0% | ||
| Length | ≥230 mm | 295-325 mm | Length | ≥230 mm | 295 -325 mm | ||
| Width | 85-105mm | 85-105mm | Width | 85-105mm | 85-105mm | ||
| FingerThickness | ≥0.05mm | 0.11- 0.19mm | FingerThickness | ≥0.05mm | 0.10- 0.19mm | ||
| PalmThickness | ≥0.05mm | 0.11 -0.16mm | PalmThickness | ≥0.05mm | 0.10 -0.16mm | ||
| UnagedTensile | ≥14 MPa | ≥14 MPa | UnagedTensile | ≥14 MPa | ≥14 MPa | ||
| UnagedElongation | ≥500% | ≥500% | UnagedElongation | ≥500% | ≥500% | ||
| Aged Tensile | ≥14 MPa | ≥14 MPa | Aged Tensile | ≥14 MPa | ≥14 MPa | ||
| AgedElongation | ≥400% | ≥500% | AgedElongation | ≥400% | ≥500% | ||
| Powder | ≤2mg/glove | ≤2mg/glove | Powder | ≤2mg/glove | ≤2mg/glove | ||
| The Halyard specifications listed aboveconform to or exceed the ASTM D6319Standard Specification. | The Kimberly Clark specifications listedabove conform to or exceed the ASTMD6319 Standard Specification. | ||||||
| ISO 10993-10 Biologicalevaluation of medicaldevices -Tests forIrritation | Based on an evaluation | Acceptance criteria: No erythema/edema up to 72 hours post exposure.Result: Erythema/edema wasnegligible. Meets acceptance criteria.PASS | |||||
| ISO 10993-10 Biologicalevaluation of medicaldevices - Tests for SkinSensitization | according to ISO 10993-1, itwas determined that noadditional testing on thesubject glove was needed. | Acceptance criteria: No evidenceof delayed dermal contact sensitivityat 24 and 48 hours post injection.Result: Not a sensitizer underconditions of the study. Meetsacceptance criteria. PASS | |||||
| ISO 10993-11 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 | ||||||
| Conclusion | The performance data support the conclusion that the subject device is as safe, as effective,and performs as well as the legally marketed device that was submitted and cleared underK113423. |
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The HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves were tested for use with the following drug concentrations per ASTM D6978-05. All study results were acceptable.
| AdditionalChemotherapeuticDrugs tested | DrugConcentration | ChemotherapeuticDrugs Listed onPredicate labeling | DrugConcentration |
|---|---|---|---|
| Arsenic Trioxide | 1 mg/ml | Bleomycin sulfate | 15 mg/ml |
| Azacitidine (Vidaza) | 25 mg/ml | Busulfan | 6 mg/ml |
| Bendamustine | 5 mg/ml | Carboplatin | 10 mg/ml |
| Bortezomib (Velcade) | 1 mg/ml | Cisplatin | 1 mg/ml |
| Carfilzomib | 2 mg/ml | Cyclophosphamide | 20 mg/ml |
| Cetuximab (Erbitux) | 2 mg/ml | Cytarabine HCI | 100 mg/ml |
| Cytovene | 10 mg/ml | Dacarbazine | 10 mg/ml |
| Decitabine | 5 mg/ml | Daunorubicin Hcl | 5 mg/ml |
| Eribulin Mesylate | 0.5 mg/ml | Docetaxel | 10 mg/ml |
| Fulvestrant | 50 mg/ml | Doxorubicin HCI | 2 mg/ml |
| Oxaliplatin | 2mg/ml | Ellence | 2 mg/ml |
| Paraplatin | 10 mg/ml | Etoposide | 20 mg/ml |
| Pemetrexed | 25 mg/ml | Fludarabine | 25 mg/ml |
| Pertuzumab | 30 mg/ml | Fluorouracil | 50 mg/ml |
| Raltitrexed | 0.5 mg/ml | Gemcitabine | 38 mg/ml |
| Retrovir | 10 mg/ml | Idarubicin | 1 mg/ml |
| Temsirolimus | 25 mg/ml | Ifosfamide | 50 mg/ml |
| Topotean HCl | 1 mg/ml | Irinotecan | 20 mg/ml |
| Trastuzumab | 21 mg/ml | Mechlorethamine HCI | 1 mg/ml |
| Triclosan | 1 mg/ml | Melphalan | 5 mg/ml |
| Vinblastine | 1 mg/ml | Methotrexate | 25 mg/ml |
| Vinorelbine | 10 mg/ml | Mitomycin | 0.5 mg/ml |
| Zoledronic Acid | 0.8 mg/ml | Mitoxantrone | 2 mg/ml |
The following drugs had NO breakthrough detected up to 240 minutes:
Carmustine was retested on the subject device with breakthrough detected in 80.4 minutes at a concentration of 3.3 mg/ml. The predicate device had breakthrough detected at 30.7 minutes.
Paclitaxel
Rituximab
ThioTEPA
Vincrinstine Sulfate
Trisenox
6 mg/ml
10 mg/ml
10 mg/ml
0.1 mg/ml 1 mg/ml
{8}------------------------------------------------
| Technological Characteristicsand Substantial Equivalence: | The HALYARD* PURPLE NITRILE – XTRA* Powder-Free ExamGloves is substantially equivalent to the predicate device,Kimberly-Clark Purple Nitrile-XTRA Powder-Free Exam Glovestested for use with chemotherapy drugs (K113423). We aresubmitting this 510(k) for clearance of expanded chemotherapydrug claim on the product labeling based on testing in accordancewith ASTM D6978-05 for chemical permeation to twenty three (23)additional chemotherapy drugs with improved permeation toCarmustine. The test results demonstrate no new issues of safetyand efficacy. |
|---|---|
| Summary of Testing: | These gloves have been tested for conformance to the applicablesections of the following standards: |
| ASTM D6978-05 Standard Practice for Assessment of Resistanceof Medical Gloves to Permeation by Chemotherapy Drugs | |
| ASTM D5151-06 Standard Test Method for Detection of Holes inMedical Gloves | |
| ASTM D6319-10 Standard Specification for Nitrile ExaminationGloves for Medical Applications | |
| ASTM D6124-06 Standard Test Method for Residual Powder onMedical Gloves | |
| ALL RESULTS OF TESTING MET ACCEPTANCE CRITERIA. | |
| Brief Description of ClinicalTests: | No new clinical tests were required to support this 510(k)notification. |
| Conclusion: | The performance data support the conclusion that the subjectdevice is as safe, as effective, and performs as well as thelegally marketed device that was submitted and cleared underK113423. |
§ 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.