(207 days)
The Halyard Purple Xtra Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable devices 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 and Fentanyl Citrate as per ASTM -D6978-05:
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
Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes
Carmustine (3.3 mg/ml) permeation occurred at 169.8 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 (1 mg/ml) No breakthrough up to 240 minutes
Trisenox (0.1 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
Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable, purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile patient examination gloves.
This document is a 510(k) premarket notification for Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. It describes the device's technical characteristics and performance data compared to a predicate device.
The acceptance criteria and study that proves the device meets them are related to the physical and chemical properties of the gloves and their barrier efficacy against certain hazardous substances, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone algorithm performance, ground truth establishment for training set) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding the acceptance criteria and the performance studies that were conducted to support the substantial equivalence claim.
Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for these exam gloves is based on established ASTM and ISO standards for medical gloves, focusing on their physical integrity, powder content, biocompatibility, and resistance to permeation by chemotherapy drugs and fentanyl citrate.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Standard | Acceptance Criteria | Reported Device Performance (Subject Device) |
|---|---|---|---|
| Dimensions | ASTM D6319 | Length $\geq$ 230mm; Palm width (size-specific range); Finger/Palm Thickness $\geq$ 0.050 mm; Cuff Thickness 0.10-0.13 mm (Halyard) | The physical dimensions of the subject device are within the limits of the standard. |
| Physical Properties (Tensile Strength & Ultimate Elongation) | ASTM D6319 | Before Aging: Tensile Strength $\geq$ 14 MPa, Ultimate elongation $\geq$ 500%After Aging: Tensile Strength $\geq$ 14 MPa, Ultimate elongation $\geq$ 400% | Physical properties of the subject device meet the requirements for tensile strength and elongation in the standard. |
| Freedom from Pinholes | ASTM D6319, ASTM D5151 | AQL 2.5% (Acceptable Quality Level for leakage)No leakage | Testing of the subject device shows it meets the AQL requirement in the standards for leakage. |
| Powder-Free | ASTM D6124, ASTM D6319 | $\le$ 2 mg / glove (maximum powder per glove) | Residual powder on the subject device is within the powder-free limits prescribed in the standards (average of 0.4 mg/glove). |
| ISO Indirect Irritation Study | ISO 10993, Part 10 | Primary Irritation Index $\le$ 2.0 | Under the conditions of the study, the device is not an irritant. |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals | No evidence of systemic toxicity. |
| ISO Dermal Sensitization | ISO 10993, Part 10 | Grade < 1 | Under the conditions of the study, the device is not a sensitizer. |
| Resistance to Permeation by Chemotherapy Drugs | ASTM D6978-05 | No breakthrough was detected for up to 240 minutes for all listed chemotherapy drugs (with specific breakthrough time noted for Carmustine) | Performance for subject device: 51 chemotherapy drugs showed no breakthrough for up to 240 minutes, except for Carmustine which had permeation at 169.8 minutes. This is documented against the predicate device's performance where Carmustine permeated at 48.6 minutes. This indicates better performance for the subject device regarding Carmustine. |
| Resistance to Permeation by Fentanyl Citrate Injection | ASTM D6978-05 | No breakthrough up to 240 minutes | No signs of breakthrough after 4 hours for Fentanyl Citrate Injection (100 mcg/2ml). This was a new claim not tested for the predicate device. |
| Clinical Study (for Type IV allergic contact sensitization) | Jordan-King modification of the Draize test (as recommended by FDA) | (Implied: Device is non-irritating and shows no clinical evidence of residual chemical additives that may induce Type IV allergy) | A 204 subject study was completed. Under the conditions of the study, the subject device was non-irritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. |
2. Sample Size for the Test Set and Data Provenance:
- Non-Clinical Tests: For tests based on ASTM standards (e.g., D6319, D5151, D6124, D6978), the sample sizes are determined by the specific standard's testing methodology, often involving a certain number of gloves per batch or condition to achieve statistical significance (e.g., AQL for pinholes). The document does not explicitly state these per-test sample sizes but confirms adherence to the standards.
- Biocompatibility Tests (ISO 10993): These involve animal testing, with sample sizes determined by the ISO standards for systemic toxicity, irritation, and sensitization. The document doesn't provide the exact number of animals but states the acceptance criteria were met.
- Clinical Study (Type IV Allergic Contact Sensitization): A 204 subject study was completed.
- Data Provenance: The document does not specify the country of origin for the non-clinical or clinical test data. Given it's an FDA submission for a US-based company (O & M Halyard, Inc., Alpharetta, GA), it's highly probable the testing was conducted in the US or in labs compliant with US regulatory requirements. The studies implicitly appear to be prospective studies conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- N/A. The ground truth for this device is based on objective laboratory measurements and standardized test procedures (e.g., chemical breakthrough, physical dimensions, tensile strength, biological responses in animal/human models as per ISO/ASTM standards). It does not involve expert consensus on interpreting images or clinical cases like an AI/ML diagnostic device would.
4. Adjudication Method for the Test Set:
- N/A. Adjudication is not relevant to the nature of these physical and chemical performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- N/A. This is a physical product, not an AI/ML diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
- N/A. This is a physical product.
7. The Type of Ground Truth Used:
- The ground truth for this device's performance is established through objective, standardized laboratory measurements and biological responses to samples of the device, as defined by ASTM and ISO protocols. This includes:
- Quantitative measurements (e.g., length, thickness, tensile strength, residual powder, breakthrough time for chemicals).
- Qualitative observations of biological reactions in animal models (for toxicity, irritation, sensitization).
- Clinical observations in human subjects (for allergic sensitization).
8. The Sample Size for the Training Set:
- N/A. There is no "training set" in the context of this traditional medical device. The device's manufacturing process and material composition are developed and optimized through R&D, not trained on data in a machine learning sense.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As there is no training set for this type of device, this question is not applicable. The device's design and manufacturing rely on established engineering principles and material science, validated through the non-clinical and clinical testing described.
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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, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 13, 2020
O & M Halyard, Inc. Steven Dowdley Associate Director of Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K192241
Trade/Device Name: Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves 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, LZC, QDO Dated: February 10, 2020 Received: February 12, 2020
Dear Steven Dowdley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192241 Device Name
The Halyard Puple Xtra Steile, Low Dermatitis Potential Nitule Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citiate
Indications for Use (Describe)
The Halyad Purple Xtra Steile, Low Dermatitis Potental Nutile Powder-Fiee Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citateis are disposable devices intended for medical purposes that is worn on the examinel's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05 :
Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes Azacıtıdine (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 Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 169.8 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladiibine (1 0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cytarabıne 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 breakthıough 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 Ep11 ubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabıne (25 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50 mg/ml) No breakthıough 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 Iiinotecan (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 mınutes Mitoxantıone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatın (2 mg/ml) No breaktlı ough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Paraplatın (10 mg/ml) No breakthrough up to 240 mınutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
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Pertuzumab (30 mg/ml) No breakthrough up to 240 mınutes Raltitlexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovii (10 mg/ml) No breakthrough up to 240 minutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsuolimus (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 (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 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
Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue. The design inside the circle appears to be two curved shapes, one white and one green.
510(k) Summary – K192241
| Date Summarywas Prepared | March 12, 2020 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc.5405 Windward ParkwayAlpharetta, GA 30004 |
| Primary Contact forthis 510(k) Submission | Steven Dowdley, RACTel: 678-451-8062Email: steven.dowdley@hyh.com |
| Device Trade Name | Halyard Purple Xtra Sterile, Low Dermatitis Potential, Powder-Free ExamGloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
| Halyard Purple Sterile, Low Dermatitis Potential, Powder-Free Exam GlovesTested for Use with Chemotherapy Drugs and Fentanyl Citrate | |
| Device Common Name | Medical Exam Gloves |
| Device Product Codeand Classification Name | LZAClass I, 21 CFR §880.6250Patient Examination Glove |
| Subsequent Product Codes | LZCClass I, 21 CFR §880.6250Patient Examination Glove, SpecialtyQDOClass I, 21 CFR §880.6250Fentanyl and other opioid protection glove |
| Predicate Device | K102032KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREEEXAM GLOVE (CHEMOTHERAPY GLOVE) |
| Subject Device Description | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and FentanylCitrate are disposable, purple-colored, chlorinated, nitrile, powder-free,textured fingertip, ambidextrous, sterile patient examination gloves.The devices follow consensus standards:· ASTM D5151-06 Standard Test Method for Detection of Holes inMedical Gloves· ASTM D6319-10 Standard Specification for Nitrile Examination Glovesfor Medical Applications• ASTM D6124-06 Standard Test Method for Residual Powder on MedicalGloves· ASTM D6978-05 Standard Practice for Assessment of Resistance ofMedical Gloves to Permeation by Chemotherapy Drugs· ISO 10993-11:2017, 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 Sensitization |
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Image /page/5/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, block letters. The design inside the circle appears to be two stylized shapes, one white and one green.
| Indications for Use | The Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and FentanylCitrate are disposable devices intended for medical purposes that is worn onthe examiner's hand to prevent contamination between patient and examiner.These gloves were tested for use with the following chemotherapy drugs andFentanyl Citrate as per ASTM -D6978-05:Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutesAzacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutesBendamustine (5 mg/ml) No breakthrough up to 240 minutesBortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutesBleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutesBusulfan (6 mg/ml) No breakthrough up to 240 minutesCarboplatin (10 mg/ml) No breakthrough up to 240 minutesCarfilzomib (2 mg/ml) No breakthrough up to 240 minutesCarmustine (3.3 mg/ml) permeation occurred at 169.8 minutesCetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutesCisplatin (1 mg/ml) No breakthrough up to 240 minutesCladribine (1.0 mg/ml) No breakthrough up to 240 minutesCyclophosphamide (20 mg/ml) No breakthrough up to 240 minutesCytarabine HCL (100 mg/ml) No breakthrough up to 240 minutesCytovene (10 mg/ml) No breakthrough up to 240 minutesDacarbazine (10 mg/ml) No breakthrough up to 240 minutesDaunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutesDecitabine (5 mg/ml) No breakthrough up to 240 minutesDocetaxel (10 mg/ml) No breakthrough up to 240 minutesDoxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutesEpirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutesEtoposide (20 mg/ml) No breakthrough up to 240 minutesFludarabine (25 mg/ml) No breakthrough up to 240 minutesFluorouracil (50 mg/ml) No breakthrough up to 240 minutesFulvestrant (50 mg/ml) No breakthrough up to 240 minutesGemcitabine (38 mg/ml) No breakthrough up to 240 minutesIdarubicin (1 mg/ml) No breakthrough up to 240 minutesIfosfamide (50 mg/ml) No breakthrough up to 240 minutesIrinotecan (20 mg/ml) No breakthrough up to 240 minutesMechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutesMelphalan (5 mg/ml) No breakthrough up to 240 minutesMethotrexate (25 mg/ml) No breakthrough up to 240 minutesMitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutesMitoxantrone (2 mg/ml) No breakthrough up to 240 minutesOxaliplatin (2 mg/ml) No breakthrough up to 240 minutesPaclitaxel (6 mg/ml) No breakthrough up to 240 minutesParaplatin (10 mg/ml) No breakthrough up to 240 minutesPemetrexed (25 mg/ml) No breakthrough up to 240 minutesPertuzumab (30 mg/ml) No breakthrough up to 240 minutesRaltitrexed (0.5 mg/ml) No breakthrough up to 240 minutesRetrovir (10 mg/ml) No breakthrough up to 240 minutesRituximab (10 mg/ml) No breakthrough up to 240 minutesTemsirolimus (25 mg/ml) No breakthrough up to 240 minutesTrastuzumab (21 mg/ml) No breakthrough up to 240 minutesThioTEPA (10 mg/ml) No breakthrough up to 240 minutesTopotecan HCL (1 mg/ml) No breakthrough up to 240 minutesTriclosan (1 mg/ml) No breakthrough up to 240 minutesTrisenox (0.1 mg/ml) No breakthrough up to 240 minutesVincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutesVinblastine (1 mg/ml) No breakthrough up to 240 minutesVinorelbine (10 mg/ml) No breakthrough up to 240 minutes | Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes | |
|---|---|---|---|
| Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes. |
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Image /page/6/Picture/0 description: The image shows the logo for Halyard. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, bold letters. The design inside the circle appears to be two curved shapes, one white and one green, resembling sails or stylized mountains.
Technological Characteristics Comparison Table
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| K192241 | K102032 | ||
| FDA Product Code | LZA, LZC, QDO | LZC, LZA | Same |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | Halyard Purple Xtra andPurple Sterile, LowDermatitis Potential,Powder-Free ExamGloves Tested for Usewith ChemotherapyDrugs and FentanylCitrate | Kimberly Clark Purple Xtraand Purple Sterile, Powder-Free Exam Gloves Tested forUse with ChemotherapyDrugs | Same |
| Intended Use | The Halyard Purple Xtraand Purple Sterile, LowDermtatis Potential,Powder-Free ExamGloves Tested for Usewith ChemotherapyDrugs and FentanylCitrates are disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves weretested for use withchemotherapy drugslisted on the label. | Kimberly Clark Purple Xtraand Purple Sterile, Powder-Free Exam Gloves Tested forUse with ChemotherapyDrugs are disposable deviceintended for medical purposesthat is worn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves were tested foruse with chemotherapy drugslisted on the label. | Different |
| TechnologicalCharacteristics | The glove is a colored,nitrile, powder-free,textured fingertip,ambidextrous, patientexamination glove. | The glove is a colored, nitrile,powder-free, texturedfingertip, ambidextrous,patient examination glove. | Same |
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Sterile | Sterile | Same |
| Biocompatibility | Based ISO 10993Biological evaluation ofMedical devices - Testfor Systemic Injection,the test article wasconsidered non-toxic.Meets the acceptancecriteria. | Based ISO 10993 Biologicalevaluation of Medical devices- Test for Systemic Injection,the test article wasconsidered non-toxic. Meetsthe acceptance criteria. | Same |
| Based on ISO 10993-Biological evaluation ofMedical Devices – Testfor Skin Irritation, thedevice extracts were notfound to cause asystemic response in theanimal model. Meets theacceptance criteria. | Based on ISO 10993-Biological evaluation ofMedical Devices - Test forSkin Irritation, the deviceextracts were not found tocause a systemic response inthe animal model. Meets theacceptance criteria. |
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Image /page/7/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, sans-serif font. The design inside the circle appears to be two curved shapes, one white and one green, creating a stylized image.
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Image /page/8/Picture/0 description: The image shows the logo for Halyard. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, sans-serif font. The design inside the circle appears to be two stylized shapes, one white and one green, resembling sails or stylized mountains.
| Standard | ResultsSubject Devices | ResultsPredicate Devices K102032 | Remarks |
|---|---|---|---|
| ASTM D6978-05StandardPractice forAssessment ofResistance ofMedical Glovesto Permeation byChemotherapyDrugs | Arsenic Trioxide (1 mg/ml) Nobreakthrough up to 240 minutes | Bleomycin sulfate (15 mg/ml) Nobreakthrough up to 240 minutes | Similar |
| Azacitidine (Vidaza) (25 mg/ml) Nobreakthrough up to 240 minutes | Busulfan (6 mg/ml) No breakthrough up to240 minutes | ||
| Bendamustine (5 mg/ml) Nobreakthrough up to 240 minutes | Carboplatin (10 mg/ml) No breakthrough upto 240 minutes | ||
| Bortezomib (Velcade) (1 mg/ml) Nobreakthrough up to 240 minutes | Carmustine (3.3 mg/ml) permeationoccurred at 48.6 minutes | ||
| Bleomycin sulfate (15 mg/ml) Nobreakthrough up to 240 minutes | Cyclophosphamide (20 mg/ml) Nobreakthrough up to 240 minutes | ||
| Busulfan (6 mg/ml) No breakthrough upto 240 minutes | Cytarabine HCL (100 mg/ml) Nobreakthrough up to 240 minutes | ||
| Carboplatin (10 mg/ml) No breakthroughup to 240 minutes | Dacarbazine (10 mg/ml) No breakthroughup to 240 minutes | ||
| Carfilzomib (2 mg/ml) No breakthroughup to 240 minutes | Daunorubicin HCL (5 mg/ml) Nobreakthrough up to 240 minutes | ||
| Carmustine (3.3 mg/ml) permeationoccurred at 169.8 minutes | Docetaxel (10 mg/ml) No breakthrough upto 240 minutes | ||
| Cetuximab (Erbitux) (2 mg/ml) Nobreakthrough up to 240 minutes | Doxorubicin HCL (2 mg/ml) Nobreakthrough up to 240 minutes | ||
| Cisplatin (1 mg/ml) No breakthrough upto 240 minutes | Epirubicin (Ellence) (2 mg/ml) Nobreakthrough up to 240 minutes | ||
| Cladribine (1.0 mg/ml) No breakthroughup to 240 minutes | Etoposide (20 mg/ml) No breakthrough upto 240 minutes | ||
| Cyclophosphamide (20 mg/ml) Nobreakthrough up to 240 minutes | Fludarabine (25 mg/ml) No breakthrough upto 240 minutes | ||
| Cytarabine HCL (100 mg/ml) Nobreakthrough up to 240 minutes | Fluorouracil (50 mg/ml) No breakthrough upto 240 minutes | ||
| Cytovene (10 mg/ml) No breakthroughup to 240 minutes | Gemcitabine (38 mg/ml) No breakthroughup to 240 minutes | ||
| Dacarbazine (10 mg/ml) Nobreakthrough up to 240 minutes | Idarubicin (1 mg/ml) No breakthrough up to240 minutes | ||
| Daunorubicin HCL (5 mg/ml) Nobreakthrough up to 240 minutes | Ifosfamide (50 mg/ml) No breakthrough upto 240 minutes | ||
| Decitabine (5 mg/ml) No breakthroughup to 240 minutes | Irinotecan (20 mg/ml) No breakthrough upto 240 minutes | ||
| Docetaxel (10 mg/ml) No breakthroughup to 240 minutes | Mechlorethamine HCL (1 mg/ml) Nobreakthrough up to 240 minutes |
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HALYARD
| Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes | Melphalan (5 mg/ml) No breakthrough up to 240 minutes |
|---|---|
| Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes | Methotrexate (25 mg/ml) No breakthrough up to 240 minutes |
| Etoposide (20 mg/ml) No breakthrough up to 240 minutes | Mitomycin (0.5 mg/ml) No breakthrough up to 240 minutes |
| Fludarabine (25 mg/ml) No breakthrough up to 240 minutes | Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes |
| Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes | Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes |
| Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes | Paraplatin (10 mg/ml) No breakthrough up to 240 minutes |
| Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes | Rituximab (10 mg/ml) No breakthrough up to 240 minutes |
| Idarubicin (1 mg/ml) No breakthrough up to 240 minutes | ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes |
| Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes | Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes |
| Irinotecan (20 mg/ml) No breakthrough up to 240 minutes | Vincrinstine Sulfate (1 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 breakthroughup to 240 minutes | |
| Temsirolimus (25 mg/ml) Nobreakthrough up to 240 minutes | |
| Trastuzumab (21 mg/ml) Nobreakthrough up to 240 minutes | |
| ThioTEPA (10 mg/ml) No breakthroughup to 240 minutes | |
| Topotecan HCL (1 mg/ml) Nobreakthrough up to 240 minutes | |
| Triclosan (1 mg/ml) No breakthrough upto 240 minutes | |
| Trisenox (0.1 mg/ml) No breakthroughup to 240 minutes | |
| Vincrinstine Sulfate (1 mg/ml) Nobreakthrough up to 240 minutes | |
| Vinblastine (1 mg/ml) No breakthroughup to 240 minutes | |
| Vinorelbine (10 mg/ml) No breakthroughup to 240 minutes | |
| Zoledronic Acid (0.8 mg/ml) Nobreakthrough up to 240 minutes |
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HALYARD 11
| Performance Data for Fentanyl Citrate Injection | |||
|---|---|---|---|
| Standard | ResultsSubject Devices | ResultsPredicate Devices K102032 | Remarks |
| ASTM D 6978 | Fentanyl Citrate Injection, (100mcg/2mL). No breakthrough up to 240minutes | Not tested | Different |
| ASTM D5151-06Standard TestMethod forDetection ofHoles in MedicalGloves | Testing of the subject device showsit meets the 2.5% AQL requirementin the standards for leakage. Thedevice meets the acceptance criteriaof the standard. | Testing of the subject device shows itmeets the 2.5% AQL requirement inthe standards for leakage. The devicemeets the acceptance criteria of thestandard. | Same |
|---|---|---|---|
| -------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
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Image /page/11/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue. The design inside the circle appears to be two curved shapes, one white and one green, resembling stylized sails or mountains.
| ASTM D6124-06Standard TestMethod forResidual Powderon MedicalGloves | Residual powder on the subjectdevice is an average of 0.4mg/glove within the powder-free limitof < 2 mg maximum powder perglove and meets the acceptancecriteria for powder- free. | Residual powder on the subject deviceis an average of 0.4 mg/glove withinthe powder-free limit of < 2 mgmaximum powder per glove and meetsthe acceptance criteria for powder-free. | Same |
|---|---|---|---|
| ASTM D6319-10StandardSpecification forNitrileExaminationGloves forMedicalApplications | The physical dimensions of thesubject device are within the limits ofthe standard and the physicalproperties of the subject device metthe requirements for tensile strengthbefore and after aging. The subjectdevice also met the requirement forelongation before and after aging. | The physical dimensions of the subjectdevice are within the limits of thestandard and the physical properties ofthe subject device met therequirements for tensile strengthbefore and after aging. The subjectdevice also met the requirement forelongation before and after aging. | Same |
| ISO 10993Biologicalevaluation ofmedical devices | Meets acceptance criteria | Meets acceptance criteria | Same |
Non- Clinical Testing Summary
PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICE:
| Brief descriptionof non-clinicaltests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Length $\geq$ 230mmPalm width SizeXtra-Small: 60 – 80 mmSmall: 70 – 90 mmMedium: 85 – 105 mmLarge: 100 – 120 mmXtra-Large: 110-130 mmFinger Thickness$\geq$ 0.050 mmPalm Thickness$\geq$ 0.050 mmCuff Thickness0.10-0.13 mm (Halyard) | The physicaldimensions of thesubject device arewithin the limits of thestandard. | |
| Physical Properties | ASTM D 6319 | AQL 4.0BeforeTensile Strength: $\geq$ 14 MPaUltimate elongation: $\geq$ 500%AfterTensile Strength: $\geq$ 14 MPaUltimate elongation: $\geq$ 400% | Physical propertiesof the subject devicemeet therequirements fortensile strength andelongation inthe standard. | |
| Freedom from Pinholes | ASTM D 6319ASTM D 5151 | AQL 2.5%No leakage | Testing of thesubject deviceshows it meets theAQL requirement inthestandards for leakage. | |
| Powder-Free | ASTM D 6124ASTM D 6319 | $≤$ 2 mg / glove | Residual powder onthe subject device iswithin the powder-free limits prescribedin thestandards. | |
| ISO Indirect IrritationStudy | ISO 10993, Part 10 | Primary Irritation Index$\le$ 2.0 | Under the conditions ofthestudy the device isnot an irritant. | |
| ISO Systemic ToxicityStudy | ISO 10993, Part 11 | No animals treated with testextracts exhibit greaterreaction than controlanimals | No evidence ofsystemic toxicity. | |
| ISO DermalSensitization | ISO 10993, Part 10 | Grade < 1 | Under the conditionsof the study thedevice is not asensitizer. | |
| Standard Practice forAssessment ofResistance of MedicalGloves to Permeationby ChemotherapyDrugs | ASTM D6978-05 | No breakthrough was detectedfor up to 240 minutes | Acceptance criteria:No signs ofbreakthrough for thesubject device after 4hours for 51chemotherapy drugs.Carmustine showedno signs ofbreakthrough until169.8 minutes.No signs ofbreakthrough after 4hours for FentanylCitrate Injection(100 mcg/2ml) | |
| Brief descriptionof clinical tests: | A 204 subject study was completed to evaluate whether the level of residual chemical additives in thesubject device induced Type IV allergic contact sensitization by repetitive applications to the skin ofnormal healthy human volunteers using the Jordan-King modification of the Draize test asrecommended by the FDA.Under the conditions of the study, the subject device was nonirritating and showed no clinicalevidence of residual chemical additives that may induce Type IV allergy in human subject | |||
| Conclusions: | The conclusions drawn from the nonclinical and clinical tests demonstrate that the subject devices (theHalyard Purple Xtra and Purple Sterile, Low Dermatitis Potential Powder-Free Exam Gloves Tested forUse with Chemotherapy Drugs and Fentanyl Citrate) are as safe, as effective, and performs as well asor better than the legally marketed devices cleared under K102032. |
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Image /page/12/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, bold letters. The design inside the circle appears to be an abstract representation of a sail or a similar shape.
§ 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.