(91 days)
The Halyard Purple Nitrile Max 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. These gloves were tested for use with the following chemotherapy drugs:
Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
Busulfan (6 mg/ml) No breakthrough up to 240 minutes
Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
Carlzomib (2 mg/ml) No breakthrough up to 240 minutes
Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
Cytovene (10 mg/ml) No breakthrough up to 240 minutes
Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
Decitabine (5 mg/ml) No breakthrough up to 240 minutes
Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
Etoposide (20 mg/ml) No breakthrough up to 240 minutes
Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
Melphalan (5 mg/ml) No breakthrough up to 240 minutes
Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
Retrovir (10 mg/ml) No breakthrough up to 240 minutes
Rituximab (10 mg/ml) No breakthrough up to 240 minutes
Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes
Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
Triclosan (2 mg/ml) No breakthrough up to 240 minutes
Trisonex (1 mg/ml) No breakthrough up to 240 minutes
Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes
Carmustine (3.3 mg/ml) permeation occurred at 128.5 minutes
Halyard Purple Nitrile Max Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs (K182096).
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for this specific type of medical glove. It is crucial to understand that this is a physical medical device, not software or AI, so the typical AI-related terms like "training set," "test set," "human-in-the-loop," "MRMC," "adjudication," and "expert qualifications" are not applicable in this context. The "studies" here refer to laboratory testing of physical properties.
Here's the breakdown of the acceptance criteria and the proof it meets them, based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Standard / Characteristic | Acceptance Criteria | Reported Device Performance (Subject Device K182096) |
|---|---|---|
| ASTM D6978-05 (Permeation by Chemotherapy Drugs) | - No breakthrough up to 240 minutes for listed chemotherapy drugs.- For Carmustine, the acceptance criterion is that permeation occurs at a time greater than the predicate device. | - No signs of breakthrough after 4 hours (240 minutes) for 51 drugs.- Carmustine showed no signs of breakthrough until 128.5 minutes (which is longer than the predicate's 80.4 minutes).- Result: Meets acceptance criteria.Specific Drugs tested showing No Breakthrough up to 240 minutes: Arsenic Trioxide (1 mg/ml), Azacitidine (Vidaza) (25 mg/ml), Bendamustine (5 mg/ml), Bortezomib (Velcade) (1 mg/ml), Bleomycin sulfate (15 mg/ml), Busulfan (6 mg/ml), Carboplatin (10 mg/ml), Carfilzomib (2 mg/ml), Cetuximab (Erbitux) (2 mg/ml), Cisplatin (1 mg/ml), Cladribine (1.0 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCL (100 mg/ml), Cytovene (10 mg/ml), Dacarbazine (10 mg/ml), Daunorubicin HCL (5 mg/ml), Decitabine (5 mg/ml), Docetaxel (10 mg/ml), Doxorubicin HCL (2 mg/ml), Epirubicin (Ellence) (2 mg/ml), Etoposide (20 mg/ml), Fludarabine (25 mg/ml), Fluorouracil (50 mg/ml), Fulvestrant (50 mg/ml), Gemcitabine (38 mg/ml), Idarubicin (1 mg/ml), Ifosfamide (50 mg/ml), Irinotecan (20 mg/ml), Mechlorethamine HCL (1 mg/ml), Melphalan (5 mg/ml), Methotrexate (25 mg/ml), Mitomycin-C (0.5 mg/ml), Mitoxantrone (2 mg/ml), Oxaliplatin (2 mg/ml), Paclitaxel (6 mg/ml), Paraplatin (10 mg/ml), Pemetrexed (25 mg/ml), Pertuzumab (30 mg/ml), Raltitrexed (0.5 mg/ml), Retrovir (10 mg/ml), Rituximab (10 mg/ml), Temsirolimus (25 mg/ml), Trastuzumab (21 mg/ml), ThioTEPA (10 mg/ml), Topotecan HCL (1 mg/ml), Triclosan (2 mg/ml), Trisonex (1 mg/ml), Vincrinstine Sulfate (1 mg/ml), Vinblastine (1 mg/ml), Vinorelbine (10 mg/ml), Zoledronic Acid (0.8 mg/ml). |
| ASTM D5151-06 (Detection of Holes in Medical Gloves) | Meets the 2.5% AQL (Acceptable Quality Level) requirement for leakage. | Testing shows it meets the 2.5% AQL requirement. The device meets the acceptance criteria. |
| ASTM D6124-06 (Residual Powder on Medical Gloves) | Powder-free limit of < 2 mg maximum powder per glove. | Residual powder is an average of 0.4 mg/glove, which is within the powder-free limit. The device meets the acceptance criteria for powder-free. |
| ASTM D6319-10 (Nitrile Examination Gloves for Medical Applications) | Physical dimensions are within limits of the standard, and physical properties (tensile strength and elongation) meet requirements. | Physical dimensions are within the limits of the standard. Tensile strength: average before aging 36.80 MPa, after aging 41.06 MPa. Elongation: 748% before aging, 627% after aging. (These values are implicitly shown to meet the standard's requirements, as "The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device meet the requirements for tensile strength... and elongation.") |
| ISO 10993-11 (Tests for Systemic Toxicity) | No signs of systemic toxicity up to 72 hours post injection. | No systemic toxicity observed. Result: Meets acceptance criteria. |
| ISO 10993-10 (Tests for Irritation and Skin Sensitization) | Sensitization: Grades of less than 1 observed in the test group, and positive control performed as anticipated.Irritation: Grades of less than 1 observed. | Sensitization: Test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig (Grade 0). Result: Meets acceptance criteria.Irritation: Based on the criteria of the protocol, the glove was considered non-irritating. Result: Meets acceptance criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of gloves tested) for each specific test. It only refers to compliance with standards like ASTM D5151-06 (2.5% AQL), which implies a statistically appropriate sample size was used as defined by that standard.
- Data Provenance: The studies were laboratory tests conducted by the manufacturer (Owens & Minor Halyard, Inc., Alpharetta, Georgia, USA) to demonstrate compliance with international standards (ASTM, ISO). The data is prospective in the sense that it was generated specifically for this regulatory submission. It is not patient data or retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this type of device and study. The "ground truth" for physical device performance (e.g., permeation, hole detection, tensile strength) is not established by human experts in the way it is for AI models interpreting medical images. Instead, it is established by adherence to validated and standardized laboratory test methods (e.g., ASTM, ISO guidelines) and objective measurements. The expertise lies in the certified laboratories and personnel performing these standardized tests.
4. Adjudication Method for the Test Set
This question is not applicable. Since the "ground truth" is based on objective laboratory measurements and standardized protocols, there is no need for expert adjudication in the context of human interpretation of data.
5. 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
This question is not applicable. An MRMC study is relevant for AI (software) devices where human readers interpret medical images or data. This document describes a physical medical device (gloves) and its laboratory performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. "Standalone" performance refers to an algorithm's performance without human intervention. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is based on objective measurements and adherence to recognized performance standards derived from laboratory testing methodologies. These standards define acceptable levels of performance for specific physical and chemical properties (e.g., maximum allowable permeation by chemotherapy drugs, acceptable hole rates, minimum tensile strength, non-toxicity).
8. The sample size for the training set
This question is not applicable. This is a physical device, not an AI model. There is no "training set."
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set for a physical device, there is no ground truth established for it in this context. The "ground truth" for the device's performance is established by the methods outlined in standards like ASTM and ISO.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 2, 2018
Owens & Minor Halyard, Inc. Angela Bunn Director Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K182096
Trade/Device Name: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC Dated: August 2, 2018 Received: August 3, 2018
Dear Angela Bunn:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -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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Indications for Use
510(k) Number (if known) K182096
Device Name
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Halyard Purple Nitrile Max 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. These gloves were tested for use with the following chemotherapy drugs:
- · Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
- · Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
- · Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
- Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
- · Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
- · Busulfan (6 mg/ml) No breakthrough up to 240 minutes
- Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
- Carlzomib (2 mg/ml) No breakthrough up to 240 minutes
- Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
- · Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
- · Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
- · Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
- · Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
- Cytovene (10 mg/ml) No breakthrough up to 240 minutes
- · Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
- · Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
- Decitabine (5 mg/ml) No breakthrough up to 240 minutes
- Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
- · Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
- · Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
- Etoposide (20 mg/ml) No breakthrough up to 240 minutes
- Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
- · Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
- Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
- · Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
- Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
- · Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
- Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
- · Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
- Melphalan (5 mg/ml) No breakthrough up to 240 minutes
- · Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
- Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
- · Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
- Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
- Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
- Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
- Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
- Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
- Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
- · Retrovir (10 mg/ml) No breakthrough up to 240 minutes
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| • Rituximab (10 mg/ml) | No breakthrough up to 240 minutes |
|---|---|
| • Temsirolimus (25 mg/ml) | No breakthrough up to 240 minutes |
| • Trastuzumab (21 mg/ml) | No breakthrough up to 240 minutes |
| • ThioTEPA (10 mg/ml) | No breakthrough up to 240 minutes |
| • Topotecan HCL (1 mg/ml) | No breakthrough up to 240 minutes |
| • Triclosan (2 mg/ml) | No breakthrough up to 240 minutes |
| • Trisonex (1 mg/ml) | No breakthrough up to 240 minutes |
| • Vincrinstine Sulfate (1 mg/ml) | No breakthrough up to 240 minutes |
| • Vinblastine (1 mg/ml) | No breakthrough up to 240 minutes |
| • Vinorelbine (10 mg/ml) | No breakthrough up to 240 minutes |
| • Zoledronic Acid (0.8 mg/ml | |
| Carmustine (3.3 mg/ml) | permeation occurred at 128.5 minutes |
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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K182096 510(k) Summary
| Date Summarywas Prepared | November 1, 2018 |
|---|---|
| Submitter | Owens & Minor Halyard, Inc.5405 Windward ParkwayAlpharetta, GA 30004 USA |
| Primary Contact forthis Submission | Angela L. Bunn, RACDirector Regulatory AffairsTel: 470-448-5856Email: angela.bunn@hyh.com |
| Device Trade Name | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use withChemotherapy Drugs |
| Device Common Name | Patient Examination Glove |
| Device Product Codeand Classification Name | LZCClass I, 21 CFR §880.6250Patient Examination Glove |
| Predicate Device | K160709Halyard Purple Nitrile-Xtra Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs |
| Subject Device Description | Halyard Purple Nitrile Max Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs are disposable, purple-colored, chlorinated,nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patientexamination gloves that are packed in a cardboard dispenser box |
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| Indications for Use | The Halyard Purple Nitrile Max Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carlzomib (2 mg/ml) No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes Cytovene (10 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes Decitabine (5 mg/ml) No breakthrough up to 240 minutes Docetaxel (10 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabine (25 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes Idarubicin (1 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes Irinotecan (20 mg/ml) No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes Melphalan (5 mg/ml) No breakthrough up to 240 minutes Methotrexate (25 mg/ml) No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Paraplatin (10 mg/ml) No breakthrough up to 240 minutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (2 mg/ml) No breakthrough up to 240 minutes Trisonex (1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 128.5 minutes |
|---|---|
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Technological CharacteristicComparison Table | Subject DevicePurple-colored, 16 inch, 0.24 mmthick at palm, nitrile, powder-free,textured fingertip, ambidextrous,non- sterile patient examinationglove. | Predicate K160709Purple-colored, 12 inch, 0.11 mm thickat palm, nitrile, powder-free, texturedfingertip, ambidextrous, non- sterilepatient examination glove. | |
|---|---|---|---|
| Subject Device K182096 | Predicate Device K160709 | Comparison | |
| FDA ProductCode | LZC | LZC | Same |
| FDAClassification | Class I | Class I | Same |
| Common Name | Patient Exam Glove | Patient Exam Glove | Same |
| Device TradeName | Halyard Purple Nitrile Max Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs | Halyard Purple Nitrile XtraPowder-Free Exam GlovesTested for Use withChemotherapy Drugs | Similar |
| Intended Use | The Halyard Purple Nitrile MaxPowder-Free Nitrile Exam Glove isa disposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patient andexaminer. These gloves weretested for use with chemotherapydrugs listed in the IFU statement. | The Halyard Purple Nitrile-XtraPowder-Free Exam Glove is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. These gloves weretested for use with chemotherapydrugs listed in the IFU statement. | Same |
| TechnologicalCharacteristics | Purple-colored, 16 inch, 0.24 mmthick at palm, nitrile, powder-free,textured fingertip, ambidextrous,non- sterile patient examinationglove. | Purple-colored, 12 inch, 0.11 mmthick at palm, nitrile, powder-free,textured fingertip, ambidextrous,non- sterile patient examinationglove. | Similar |
| Performance Data | |||
| Standard | ResultsSubject Device | ResultsK160709 | Remarks |
| ASTM D6978-05 | No signs of breakthrough after 4 | No signs of breakthrough after 4 | Similar with different |
| hours for 51 drugs. | hours for 51 drugs. | breakthrough times | |
| Standard | Carmustine showed no signs of | Carmustine showed no signs of | for Carmustine. |
| Practice for | breakthrough until 128.5 minutes | breakthrough until 80.4 minutes | |
| Assessment ofResistance of | Result: Meets acceptance criteria. | Result: Meets acceptance criteria. | |
| Medical Gloves | No breakthrough up to 240 | No breakthrough up to 240 | |
| to Permeation | minutes: | minutes: | |
| by | Arsenic Trioxide (1 mg/ml) | Arsenic Trioxide (1 mg/ml) | |
| Chemotherapy | Azacitidine (Vidaza) (25 mg/ml) | Azacitidine (Vidaza) (25 mg/ml) | |
| Drugs | Bendamustine (5 mg/ml) | Bendamustine (5 mg/ml) | |
| Bortezomib (Velcade) (1 mg/ml) | Bortezomib (Velcade) (1 mg/ml) | ||
| Bleomycin sulfate (15 mg/ml) | Bleomycin sulfate (15 mg/ml) | ||
| Busulfan (6 mg/ml) | Busulfan (6 mg/ml) | ||
| Carboplatin (10 mg/ml) | Carboplatin (10 mg/ml) | ||
| Carfilzomib (2 mg/ml) | Carfilzomib (2 mg/ml) | ||
| Cetuximab (Erbitux) (2 mg/ml) | Cetuximab (Erbitux) (2 mg/ml) | ||
| Cisplatin (1 mg/ml)Cladribine (1 mg/ml) | Cisplatin (1 mg/ml) | ||
| Cyclophosphamide (20 mg/ml) | Cyclophosphamide (20 mg/ml)Cytarabine HCL (100 mg/ml) | ||
| Cytarabine HCL (100 mg/ml) | Cytovene (10 mg/ml) | ||
| Cytovene (10 mg/ml) | Dacarbazine (10 mg/ml) | ||
| Dacarbazine (10 mg/ml) | Daunorubicin HCL (5 mg/ml) | ||
| Daunorubicin HCL (5 mg/ml) | Decitabine (5 mg/ml) | ||
| Decitabine (5 mg/ml) | Docetaxel (10 mg/ml) | ||
| Docetaxel (10 mg/ml) | Doxorubicin HCL (2 mg/ml) | ||
| Doxorubicin HCL (2 mg/ml) | Ellence (2 mg/ml) | ||
| Ellence (2 mg/ml) | Eribulin Mesylate (0.5 mg/ml) | ||
| Etoposide (20 mg/ml) | Etoposide (20 mg/ml) | ||
| Fludarabine (25 mg/ml)Fluorouracil (50 mg/ml) | Fludarabine (25 mg/ml) | ||
| Fulvestrant (50 mg/ml) | Fluorouracil (50 mg/ml) | ||
| Gemcitabine (38 mg/ml) | Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml) | ||
| Idarubicin (1 mg/ml) | Idarubicin (1 mg/ml) | ||
| Ifosfamide (50 mg/ml) | Ifosfamide (50 mg/ml) | ||
| Irinotecan (20 mg/ml) | Irinotecan (20 mg/ml) | ||
| Mechlorethamine HCL (1 mg/ml) | Mechlorethamine HCL (1 mg/ml) | ||
| Melphalan (5 mg/ml) | Melphalan (5 mg/ml) | ||
| Methotrexate (25 mg/ml) | Methotrexate (25 mg/ml) | ||
| Mitomycin (0.5 mg/ml) | Mitomycin (0.5 mg/ml) | ||
| Mitoxantrone (2 mg/ml) | Mitoxantrone (2 mg/ml) | ||
| Oxaliplatin (2 mg/ml) | Oxaliplatin (2 mg/ml) | ||
| Paclitaxel (6 mg/ml) | Paclitaxel (6 mg/ml) | ||
| Paraplatin (10 mg/ml)Pemetrexed (25 mg/ml) | Paraplatin (10 mg/ml) | ||
| Pertuzumab (30 mg/ml) | Pemetrexed (25 mg/ml)Pertuzumab (30 mg/ml) | ||
| Raltitrexed (0.5 mg/ml) | Raltitrexed (0.5 mg/ml) | ||
| Retrovir (10 mg/ml) | Retrovir (10 mg/ml) | ||
| Rituximab (10 mg/ml) | Rituximab (10 mg/ml) | ||
| Temsirolimus (25 mg/ml) | Temsirolimus (25 mg/ml) | ||
| Trastuzumab (21 mg/ml) | Trastuzumab (21 mg/ml) | ||
| ThioTEPA (10 mg/ml) | ThioTEPA (10 mg/ml) | ||
| Topotecan HCL (1 mg/ml) | Topotecan HCL (1 mg/ml) | ||
| Triclosan (2 mg/ml) | Triclosan (1 mg/ml) | ||
| Trisonex (1 mg/ml) | Trisonex (1 mg/ml) | ||
| Vincrinstine Sulfate (1 mg/ml) | Vincrinstine Sulfate (1 mg/ml) | ||
| Vinblastine (1 mg/ml) | Vinblastine (1 mg/ml) | ||
| Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml) | Vinorelbine (10 mg/ml) | ||
| Carmustine (3.3 mg/ml) | Zoledronic Acid (0.8 mg/ml)Carmustine (3.3 mg/ml) permeation | ||
| permeation occurred at 128.5 | occurred at 80.4 minutes | ||
| minutes | |||
| ASTM D5151-06Standard TestMethod forDetection ofHoles in MedicalGloves | Testing of the subject device shows itmeets the 2.5% AQL requirement inthe standards for leakage. The devicemeets the acceptance criteria of thestandard. | Testing of the subject deviceshows it meets the 2.5% AQLrequirement in the standards forleakage. The device meets theacceptance criteria of the standard. | Same |
| ASTM D6124-06Standard TestMethod forResidualPowder onMedical Gloves | Residual powder on the subjectdevice is an average of 0.4mg/glove within the powder-freelimit of < 2 mg maximum powderper glove and meets theacceptance criteria for powder-free. | Residual powder on the subjectdevice is an average of .4 mg/glovewithin the powder-free limit of < 2mg maximum powder per gloveand meets the acceptance criteriafor powder- free. | Same |
| ASTM D6319-10StandardSpecification forNitrileExaminationGloves forMedicalApplications | The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject devicemeet the requirements for tensilestrength with an average beforeaging of 36.80 MPa and afteraging of 41.06 MPa and elongationof 748% before aging and 627%after aging. | The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject devicemeet the requirements for tensilestrength with an average beforeaging of 38.6 MPa and after agingof 37.5 MPa and elongation of702% before aging and 584% afteraging. | Similar |
| ISO 10993Biologicalevaluation ofmedicaldevices - Testsfor SystemicToxicity | Acceptance criteria: No signs ofsystemic toxicity up to 72 hourspost injection.Result: No systemic toxicityobserved. | Acceptance criteria: No signs ofsystemic toxicity up to 72 hourspost injection.Result: No systemic toxicityobserved. | Same |
| ISO 10993Biologicalevaluation ofmedical devices- Part 10: Testsfor Irritation andSkinSensitization | SensitizationAcceptance Criteria: Therequirements of the test were metas Grades of less than 1 wereobserved in the test group and thepositive 1-chloro-2,4-dinitrobenzene (DNCB) controlpreformed as anticipated.Result: The test article extractsshowed no evidence of causingdelayed dermal contactsensitization in the guinea pig(Grade 0).IrritationAcceptance Criteria: Therequirements of the test were metas Grades of less than 1 wereobserved.Result: Based on the criteria ofthe protocol, C2016-0105 PurpleMax Powder-Free Exam Glovewas considered non-irritating. | SensitizationAcceptance Criteria: Therequirements of the test were metas Grades of less than 1 wereobserved in the test group and thepositive 1-chloro-2,4-dinitrobenzene (DNCB) controlpreformed as anticipated.Result: The test article extractsshowed no evidence of causingdelayed dermal contactsensitization in the guinea pig(Grade 0).IrritationAcceptance Criteria: Therequirements of the test were metas Grades of less than 1 wereobserved.Result: Based on the criteria of theprotocol, C2016-0105 Purple MaxPowder-Free Exam Glove wasconsidered non-irritating. | Same |
| Summary of non-clinicaltesting | Device follows consensus standards:• ASTM D5151-06 Standard Test Method for Detection of Holesin Medical Gloves• ASTM D6319-10 Standard Specification for Nitrile ExaminationGloves for Medical Applications• ASTM D6124-06 Standard Test Method for Residual Powderon Medical Gloves• ASTM D6978-05 Standard Practice for Assessment ofResistance of Medical Gloves to Permeation by ChemotherapyDrugs• ISO 10993-11:2006, Biological evaluation of medical devices -Part 11: Tests for Systemic Toxicity• ISO 10993-10: 2010: Biological evaluation of medical devices -Part 10: Tests for Irritation and Skin SensitizationThere are no different technological characteristics of the subject devicecompared to the predicate device. They are powder-free non-sterile nitrile examgloves tested for resistance to permeation by chemotherapy drugs. The subjectdevice has a longer cuff and is thicker at the palm. | ||
| Conclusion: | Performance data supports the conclusion that the subject device is as safe, aseffective, and performs as well as the legally marketed device that was submittedand cleared under K160709. |
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§ 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.