(270 days)
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
- Arsenic Trioxide (1 mg/ml)
- Bendamustine, (5 mg/ml)
- Blenoxane (15 mg/ml)
- Bleomycin (15 mg/ml)
- Bortezomib (1 mg/ml)
- Busulfan (6 mg/ml)
- Carboplatln (10 mg/ml)
- Carfilzomib (2 mg/ml)
- Cetuximab (2 mg/ml)
- Cisplatin (1 mg/ml)
- Cyclophosphamide (Cytoxan) (20 mg/ml)
- Cytarabine (100 mg/ml)
- Dacarbazine (DTIC) {10 mg/ml)
- Daunorubicin {5 mg/ml)
- Decitabine (5 mg/ml)
- Docetaxel (10 mg/ml)
- Doxorubicin HCL (2 mg/ml)
- Ellence (2 mg/ml)
- Erbitux (2 mg/ml)
- Eribilin Mesylate (0.5 mg/ml)
- Etoposide (Toposar) (20 mg/ml)
- Fludarabine (25 mg/ml)
- Fulvestrant (50 mg/ml)
- Gemcitabine (Gemzar) (38 mg/ml)
- Idarubicin (1 mg/ml)
- Ifosfamide (IFEX) (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 (Taxol) (6 mg/ml)
- Paraplatin (10 mg/ml)
- Pemetrexed Disodium (25 mg/ml)
- Pertuzumab (30 mg/ml)
- Raltitrexed (0.5 mg/ml)
- Rituximab (Rituxan) (10 mg/ml)
- Temsirolimus (25 mg/ml)
- Thiotepa (10 mg/ml)
- Topotecan HCL (1 mg/ml)
- Trastuzumab (21 mg/ml)
- Trisenox (1 mg/ml)
- Velcade (1 mg/ml)
- Vinblastine (1 mg/ml)
- Vinorelbine (10 mg/ml)
Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100 mcg/2 ml)
- Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)
Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
- Cytovene (10 mg/ml)
- Retrovir (10 mg/ml)
- Triclosan (2 mg/ml)
- Zoledronic Acid (0.8 mg/ml)
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.
The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.
However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319 | Length ≥230 mmPalm Width Size X-Small: 60 – 80 mmSmall: 70 - 90 mmMed: 85–105 mmLarge: 100 - 120 mmX-Large: 110-130 mmXX-Large: 120-140 mmFinger thickness ≥0.05 mmPalm thickness ≥0.05 mmCuff thickness ≥0.05 mm | Meets requirements |
| Physical Properties | ASTM D 6319 | AQL 4.0Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Meets requirements (Tensile strength and elongation before and after aging met requirements) |
| Freedom from Pinholes | ASTM D 6319ASTM D 5151 | AQL 2.5%No leakage | Meets requirements (Meets the 2.5% AQL requirement for leakage) |
| Powder Free | ASTM D 6124ASTM D 6319 | ≤ 2 mg / glove | Meets requirements (Average of 0.4 mg/glove, within the < 2 mg maximum powder per glove limit) |
| Test for irritation | ISO 10993, Part 23 | ≤ 0.4 | Under the conditions of the study, the device is not an irritant. |
| Test for acute systemic toxicity | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals. | Under the conditions of the study, no evidence of acute systemic toxicity. |
| Test for skin sensitization | ISO 10993, Part 10 | Grade < 1.0 | Under the conditions of the study, the device is not a sensitizer. |
| Resistance to Permeation by Chemotherapy Drugs | ASTM D6978-05 | No breakthrough for up to 240 minutes for listed drugs. Specific breakthrough time for Carmustine defined (e.g., 80.4 minutes for predicate, 60 minutes for subject). | 51 Chemotherapy drugs tested showed minimum breakthrough detection time up to 240 minutes (no breakthrough).Carmustine (3.3mg/ml) minimum breakthrough detection time is 60 minutes.Fentanyl Citrate Injection (100 mcg/2 ml) and Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution) showed minimum breakthrough detection time up to 240 minutes (no breakthrough). |
| Modified DRAIZE-95 Test (Low Dermatitis Potential) | N/A | Not explicitly defined as a numerical criterion, but implies demonstration of non-irritating and non-sensitizing properties related to chemical additives for Type IV allergic contact sensitization. | Under the conditions of the study, the subject device was nonirritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. |
2. Sample size used for the test set and the data provenance
- Chemotherapy and Hazardous Drug Permeation (ASTM D6978-05): The document does not specify the exact sample size (number of gloves/runs per drug) for the permeation tests. The data provenance is not specified, but it would have been generated from laboratory testing of the manufactured gloves.
- Biocompatibility (ISO 10993 parts 10, 11, 23): "No animals" for systemic toxicity implies a small animal study; the exact number is not stated. For irritation, an animal study is also implied. For skin sensitization, the "Grade < 1.0" implies a quantitative assessment from an animal study. Data provenance is laboratory testing.
- Physical Properties (ASTM D6319, D5151, D6124): These standards typically involve statistical sampling plans for testing batches of gloves (e.g., AQL levels). The exact number of gloves tested is not explicitly stated in the summary but assumes testing according to the standards. Data provenance is laboratory testing.
- Modified DRAIZE-95 Test (Low Dermatitis Potential):
- Sample Size: 204 human subjects.
- Data Provenance: Prospective human clinical study. The country of origin is not specified, but these types of studies for FDA clearance are generally conducted under U.S. or international clinical study guidelines.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical glove undergoing non-clinical and a small clinical study, not an AI/software device requiring expert interpretation for ground truth. The "ground truth" here is objective laboratory measurements (e.g., breakthrough time, physical dimensions, chemical residues) and clinical observations of skin reactions.
4. Adjudication method for the test set
Not applicable. For laboratory tests, results are typically determined by instrumental readings and standard protocols. For the human clinical study, it would involve direct observation and assessment by trained clinical personnel (e.g., dermatologists or nurses) of skin reactions, but an explicit adjudication method (like 2+1) usually associated with image interpretation is not mentioned.
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
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
- Chemotherapy and Hazardous Drug Permeation: Objective measurement of chemical permeation/breakthrough time using analytical techniques (e.g., gas chromatography).
- Biocompatibility: Objective biological responses in animal models (e.g., presence/absence of toxicity, irritation, sensitization).
- Physical Properties: Objective measurements (e.g., length, width, thickness, tensile strength, elongation, powder amount) and qualitative assessment for pinholes (e.g., water leak test).
- Modified DRAIZE-95 Test: Clinical observations by dermatological or trained personnel of skin irritation and allergic reactions in human subjects.
8. The sample size for the training set
Not applicable. The glove's performance is not determined by a "training set" in the context of machine learning. The manufacturing process is refined based on quality control and adherence to standards, but there isn't a "training set" like in AI.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" for this type of medical device clearance.
FDA 510(k) Clearance Letter - K243604
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 18, 2025
O&M Halyard, Inc.
Caitlin Senter
Director, Global Regulatory Affairs
1220 Old Alpharetta Rd.
Ste. 320
Alpharetta, Georgia 30005
Re: K243604
Trade/Device Name: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, OPJ, QDO
Dated: November 21, 2024
Received: July 7, 2025
Dear Caitlin Senter:
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 (the 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 available 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.
Page 2
K243604 - Caitlin Senter Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243604 - Caitlin Senter Page 3
assistance/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,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K243604
Device Name
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
Indications for Use (Describe)
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
- Arsenic Trioxide (1 mg/ml)
- Bendamustine, (5 mg/ml)
- Blenoxane (15 mg/ml)
- Bleomycin (15 mg/ml)
- Bortezomib (1 mg/ml)
- Busulfan (6 mg/ml)
- Carboplatln (10 mg/ml)
- Carfilzomib (2 mg/ml)
- Cetuximab (2 mg/ml)
- Cisplatin (1 mg/ml)
- Cyclophosphamide (Cytoxan) (20 mg/ml)
- Cytarabine (100 mg/ml)
- Dacarbazine (DTIC) {10 mg/ml)
- Daunorubicin {5 mg/ml)
- Decitabine (5 mg/ml)
- Docetaxel (10 mg/ml)
- Doxorubicin HCL (2 mg/ml)
- Ellence (2 mg/ml)
- Erbitux (2 mg/ml)
- Eribilin Mesylate (0.5 mg/ml)
- Etoposide (Toposar) (20 mg/ml)
- Fludarabine (25 mg/ml)
- Fulvestrant (50 mg/ml)
- Gemcitabine (Gemzar) (38 mg/ml)
- Idarubicin (1 mg/ml)
- Ifosfamide (IFEX) (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 (Taxol) (6 mg/ml)
- Paraplatin (10 mg/ml)
- Pemetrexed Disodium (25 mg/ml)
- Pertuzumab (30 mg/ml)
- Raltitrexed (0.5 mg/ml)
FORM FDA 3881 (8/23) Page 1 of 2
Page 5
- Rituximab (Rituxan) (10 mg/ml)
- Temsirolimus (25 mg/ml)
- Thiotepa (10 mg/ml)
- Topotecan HCL (1 mg/ml)
- Trastuzumab (21 mg/ml)
- Trisenox (1 mg/ml)
- Velcade (1 mg/ml)
- Vinblastine (1 mg/ml)
- Vinorelbine (10 mg/ml)
Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100 mcg/2 ml)
- Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)
Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
- Cytovene (10 mg/ml)
- Retrovir (10 mg/ml)
- Triclosan (2 mg/ml)
- Zoledronic Acid (0.8 mg/ml)
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 2 of 2
Page 6
510(k) Summary for K243604
Page 1 of 13
This summary of 510(k) K243604 is being submitted in accordance with 21 CFR 807.92.
| Date Summary was Prepared | July 31, 2025 |
|---|---|
| 510(k) Submitter | O&M Halyard, Inc.1220 Old Alpharetta Rd., Ste. 320Alpharetta, GA 30005 |
| Primary Contact for this 510(k) Submission | Caitlin Senter, MS, RACTel: 678-221-7330Email: caitlin.senter@owens-minor.com |
| Marketed Device Trade Name | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid |
| Device Submission Trade name and Description | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid |
| Device Common Name | Medical Exam Gloves |
| Device Product Code and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination GloveLZC Class I, 21 CFR §880.6250 medical glove, specialtyOPJ Class I, 21 CFR §880.6250 Medical Gloves with Chemotherapy Labeling Claims - Test for Use with Chemotherapy DrugsQDO Class I, 21 CFR §880.6250 Fentanyl and Other Opioid Protection Glove |
| Predicate Device | HALYARD* PURPLE NITRILE - XTRA* Powder Free-Exam Gloves (K160709) |
| Reference Device | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909) |
| Subject Device Description | The Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves. |
Page 7
Page 2 of 13
| Indications for Use | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:Arsenic Trioxide (1 mg/ml)Bendamustine, (5 mg/ml)Blenoxane (15 mg/ml)Bleomycin (15 mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Carboplatln (10 mg/ml)Carfilzomib (2 mg/ml)Cetuximab (2 mg/ml)Cisplatin (1 mg/ml)Cyclophosphamide (Cytoxan) (20 mg/ml)Cytarabine (100 mg/ml)Dacarbazine (DTIC) {10 mg/ml)Daunorubicin {5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCL (2 mg/ml)Ellence (2 mg/ml)Erbitux (2 mg/ml)Eribilin Mesylate (0.5 mg/ml)Etoposide (Toposar) (20 mg/ml)Fludarabine (25 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (Gemzar) (38 mg/ml)ldarubicin (1 mg/ml)lfosfamide (IFEX) (50 mg/ml)lrinotecan (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 (Taxol) (6 mg/ml)Paraplatin (10 mg/ml)Pemetrexed Disodium (25 mg/ml)Pertuzumab (30 mg/ml)Raltitrexed (0.5 mg/ml)Rituximab (Rituxan) (10 mg/ml)Temsirolimus (25 mg/ml)Thiotepa (10 mg/ml)Topotecan HCL (1 mg/ml)Trastuzumab (21 mg/ml)Trisenox (1 mg/ml)Velcade (1 mg/ml)Vinblastine (1 mg/ml) |
Page 8
Page 3 of 13
Vinorelbine (10 mg/ml)
Carmustine (3.3 mg/ml) permeation occurred at 60 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100 mcg/2 ml)
- Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)
Caution: Testing showed a minimum breakthrough time of 60 minutes with Carmustine.
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
- Cytovene (10 mg/ml)
- Retrovir (10 mg/ml)
- Triclosan (2 mg/ml)
- Zoledronic Acid (0.8 mg/ml)
Technological Characteristics Comparison Table
| Subject Device | Predicate Device (K160709) | Reference Device (K241909) | Comparison | |
|---|---|---|---|---|
| FDA Product Code | LZA, LZC, OPJ, QDO | LZC | LZA, LZC, OPJ, QDO | Similar |
| FDA Classification | Class I | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | 880.6250 | Same |
| Common Name | Patient Examination Glove | Patient Examination Glove | Patient Examination Glove | Same |
| Device Trade Name | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves | HAYLARD* PURPLE NITRILE – XTRA* Powder Free Exam Gloves | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Similar |
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| Intended Use/Indications for Use | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:Arsenic Trioxide (1 mg/ml)Bendamustine, (5 mg/ml)Blenoxane (15 mg/ml)Bleomycin (15 mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Carboplatln (10 mg/ml)Carfilzomib (2 mg/ml)Cetuximab (2 mg/ml)Cisplatin (1 mg/ml)Cyclophosphamide (Cytoxan) (20 mg/ml)Cytarabine (100 mg/ml)Dacarbazine (DTIC) {10 mg/ml)Daunorubicin {5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCL (2 mg/ml)Ellence (2 mg/ml)Erbitux (2 mg/ml)Eribilin Mesylate (0.5 mg/ml)Etoposide (Toposar) (20 | 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.HALYARD* PURPLE NITRILE - XTRA* Powder Pree Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutesArsenic Trioxide (1 mg/ml)Azacitidine (Vidaza) (25 mg/ml)Bendamustine (5 mg/ml)Bleomycin Sulfate (15 mg/ml)Bortezomib (Velcade) (1 mg/ml)Busulfan (6 mg/ml)Carlzomib (2 mg/ml)Carboplatin (10 mg/ml)Carmustine (3.3 mg/ml)Cetuximab (Erbitux) (2 mg/ml)Cisplatin (1 mg/ml)Cyclophosphamide (20 mg/ml)Cytarabine HCl (100 mg/ml)Cytovene (10 mg/ml)Dacarbazine (10 mg/ml) | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are 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 and Gastric Acid as per ASTM -D6978-05:The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:Azacitidine (25 mg/ml)Bendamustine HCI (5 mg/ml)Bleomycin Sulfate (15 mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26 mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50 mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20 mg/ml)Cyclosporin A (100 mg/ml) | SimilarAdding Low Dermatitis Potential claim to subject device as compared to reference predicate |
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mg/ml)Fludarabine (25 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (Gemzar) (38 mg/ml)ldarubicin (1 mg/ml)lfosfamide (IFEX) (50 mg/ml)lrinotecan (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 (Taxol) (6 mg/ml)Paraplatin (10 mg/ml)Pemetrexed Disodium (25 mg/ml)Pertuzumab (30 mg/ml)Raltitrexed (0.5 mg/ml)Rituximab (Rituxan) (10 mg/ml)Temsirolimus (25 mg/ml)Thiotepa (10 mg/ml)Topotecan HCL (1 mg/ml)Trastuzumab (21 mg/ml)Trisenox (1 mg/ml)Velcade (1 mg/ml)Vinblastine (1 mg/ml)Vinorelbine (10 mg/ml)Carmustine (3.3 mg/ml) permeation occurred at 60 minutes.The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:Fentanyl Citrate Injection (100 mcg/2 ml)Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)Caution: Testing showed a minimum breakthrough time of 60 minutes with Carmustine.The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:Cytovene (10 mg/ml)Retrovir (10 mg/ml)Triclosan (2 mg/ml)Zoledronic Acid (0.8 mg/ml) | Daunorubicin Hcl (5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2 mg/ml)Ellence (2 mg/ml)Eribulin Mesylate (0.5 mg/ml)Etoposid (20 mg/ml)Fludarabine (25 mg/ml)Fulvestrant (50 mg/ml)Fluorouracil (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 (5 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)Thiotepa (10 mg/ml)Topotecan HCl (1 mg/ml)Trastuzumab (21 mg/ml)Triclosan (1 mg/ml)Trisenox (0.1 mg/ml)Vinblastine (1 mg/ml)Vincristine Sulfate (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml) | Cytarabine (Cytosine) (100 mg/ml)Cytovene (Ganciclovir) (10 mg/ml)Dacarbazine (DTIC) (10 mg/ml)Dactinomycin (0.5 mg/ml)Daunorubicin HCI (5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2 mg/ml)Epirubicin HCl (Ellence) (2 mg/ml)Etoposide (Toposar) (20 mg/ml)Fludarabine (25 mg/ml)5-Fluorouracil (50 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml)Idarubicin (1 mg/ml)Ifosfamide (50 mg/ml)Irinotecan HCl (20 mg/ml)Leuprolide Acetate Salt (5 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 (5 mg/ml)Paclitaxel (6 mg/ml)Pemetrexed (25 mg/ml)Raltitrexed (0.5 mg/ml)Retrovir (10 mg/ml)Rituximab (10 mg/ml)Temsirolimus (25 mg/ml)Topotecan HCI (1 mg/ml)Triclosan (2 mg/ml) |
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Fentanyl Citrate Injection (100 mcg/2 ml)Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)Caution: Testing showed a minimum breakthrough time of 60 minutes with Carmustine.The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:Cytovene (10 mg/ml)Retrovir (10 mg/ml)Triclosan (2 mg/ml)Zoledronic Acid (0.8 mg/ml) | | Trisenox (1 mg/ml)Vinblastine Sulfate (1 mg/ml)Vincristine (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml)The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.Warning- Not for use with Carmustine and ThioTEPAThe following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:Fentanyl Citrate Injection (100 mcg/2 ml)Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution) (50 mcg/2 ml) |
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| Technological Characteristics | Colored, 12 inch, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove | Colored, 12 inch, chlorinated, nitrile, powder-free, textured fingertips, ambidextrous, non-sterile patient examination glove | Colored, 9.5 inch, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove | Similar |
|---|---|---|---|---|
| Sizes of gloves | XS, S, M, L, XL, XXL | XS, S, M, L, XL | XS, S, M, L, XL, XXL | Similar Adding XXL size to subject device |
| Color | Purple | Purple | Purple | Similar |
| Texture | Textured fingertips | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Based on ISO 10993, Part 11 Biological Evaluation of Medical Devices – Test for systemic toxicity, the test article was considered non- toxic. Meets the acceptance criteria.Based on ISO 10993, Part 23- Biological Evaluation of Medical Devices – Test for irritation, the test article was considered non-irritant. Meets the acceptance criteria.Based on ISO 10993, Part 10 - Biological Evaluation of Medical Devices – Test for skin sensitization, the test article was considered a non- sensitizer. Meets the acceptance criteria. | Based ISO 10993 Biological Evaluation of Medical devices – Test for systemic toxicity, the test article was considered non-toxic. Meets the acceptance criteria.Based on ISO 10993, Part 10- Biological Evaluation of Medical Devices – Test for irritation, the test article was considered non- irritant. Meets the acceptance criteria.Based on ISO 10993, Part 10 - Biological Evaluation of Medical Devices – Test for skin sensitization, the test article was considered non-sensitizer. Meets the acceptance criteria. | Based on ISO 10993, Part 11 Biological Evaluation of Medical Devices – Test for systemic toxicity, the test article was considered non- toxic. Meets the acceptance criteria.Based on ISO 10993, Part 23- Biological Evaluation of Medical Devices – Test for irritation, the test article was considered non-irritant. Meets the acceptance criteria.Based on ISO 10993, Part 10 - Biological Evaluation of Medical Devices – Test for skin sensitization, the test article was considered a non- sensitizer. Meets the acceptance criteria. | Same |
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Performance Data for Chemotherapy Drugs
| Standard | Subject Device | Predicate Device (K160709) | Reference Device (K241909) | Remarks |
|---|---|---|---|---|
| ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:Arsenic Trioxide (1 mg/ml)Bendamustine, (5 mg/ml)Blenoxane (15 mg/ml)Bleomycin (15 mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Carboplatln (10 mg/ml)Carfilzomib (2 mg/ml)Cetuximab (2 mg/ml)Cisplatin (1 mg/ml)Cyclophosphamide (Cytoxan) (20 mg/ml)Cytarabine (100 mg/ml)Dacarbazine (DTIC) {10 mg/ml)Daunorubicin {5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCL (2 mg/ml)Ellence (2 mg/ml)Erbitux (2 mg/ml)Eribilin Mesylate (0.5 mg/ml)Etoposide (Toposar) (20 mg/ml)Fludarabine (25 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (Gemzar) (38 mg/ml)ldarubicin (1 mg/ml)lfosfamide (IFEX) (50 mg/ml)lrinotecan (20 mg/ml)Mechlorethamine HCL (1 mg/ml) | HALYARD* PURPLE NITRILE - XTRA* Powder Pree Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutesArsenic Trioxide (1 mg/ml)Azacitidine (Vidaza) (25 mg/ml)Bendamustine (5 mg/ml)Bleomycin Sulfate (15 mg/ml)Bortezomib (Velcade) (1 mg/ml)Busulfan (6 mg/ml)Carlzomib (2 mg/ml)Carboplatin (10 mg/ml)Carmustine (3.3 mg/ml)Cetuximab (Erbitux) (2 mg/ml)Cisplatin (1 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)Ellence (2 mg/ml)Eribulin Mesylate (0.5 mg/ml)Etoposide (20 mg/ml)Fludarabine (25 mg/ml) | The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:Azacitidine (25 mg/ml)Bendamustine HCI (5 mg/ml)Bleomycin Sulfate (15 mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26 mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50 mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20 mg/ml)Cyclosporin A (100 mg/ml)Cytarabine (Cytosine) (100 mg/ml)Cytovene (Ganciclovir) (10 mg/ml)Dacarbazine (DTIC) (10 mg/ml)Dactinomycin (0.5 mg/ml)Daunorubicin HCI (5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2 mg/ml)Epirubicin HCl (Ellence) (2 mg/ml)Etoposide (Toposar) (20 mg/ml) | Similar |
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Melphalan (5 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2 mg/ml)Oxaliplatin (2 mg/ml)Paclitaxel (Taxol) (6 mg/ml)Paraplatin (10 mg/ml)Pemetrexed Disodium (25 mg/ml)Pertuzumab (30 mg/ml)Raltitrexed (0.5 mg/ml)Rituximab (Rituxan) (10 mg/ml)Temsirolimus (25 mg/ml)Thiotepa (10 mg/ml)Topotecan HCL (1 mg/ml)Trastuzumab (21 mg/ml)Trisenox (1 mg/ml)Velcade (1 mg/ml)Vinblastine (1 mg/ml)Vinorelbine (10 mg/ml)Carmustine (3.3 mg/ml) permeation occurred at 60 minutes.Caution: Testing showed a minimum breakthrough time of 60 minutes with Carmustine.The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:Cytovene (10 mg/ml)Retrovir (10 mg/ml)Triclosan (2 mg/ml)Zoledronic Acid (0.8 mg/ml) | Fulvestrant (50 mg/ml)Fluorouracil (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 (5 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)Thiotepa (10 mg/ml)Topotecan HCl (1 mg/ml)Trastuzumab (21 mg/ml)Triclosan (1 mg/ml)Trisenox (0.1 mg/ml)Vinblastine (1 mg/ml)Vincristine Sulfate (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml) | Fludarabine (25 mg/ml)5-Fluorouracil (50 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml)Idarubicin (1 mg/ml)Ifosfamide (50 mg/ml)Irinotecan HCl (20 mg/ml)Leuprolide Acetate Salt (5 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 (5 mg/ml)Paclitaxel (6 mg/ml)Pemetrexed (25 mg/ml)Raltitrexed (0.5 mg/ml)Retrovir (10 mg/ml)Rituximab (10 mg/ml)Temsirolimus (25 mg/ml)Topotecan HCl (1 mg/ml)Triclosan (2 mg/ml)Trisenox (1 mg/ml)Vinblastine Sulfate (1 mg/ml)Vincristine (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml)The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.Warning- Not for use with Carmustine and ThioTEPA |
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Performance Data for Hazardous Drugs (opioids)
| ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:Fentanyl Citrate Injection (100 mcg/2 ml)Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution) | Not previously tested | The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:Fentanyl Citrate Injection (100 mcg/2 ml)Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | Similar |
|---|
Performance Data
| ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves | Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. | Testing of the predicate device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. | Testing of the reference device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. | Same |
|---|---|---|---|---|
| ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves | Residual powder on the subject device is an average of 0.4 mg/glove within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder-free. | Residual powder on the predicate device is an average of 0.4 mg/glove within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder-free. | Residual powder on the reference device is an average of 0.4 mg/glove within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder-free. | Same |
| ASTM D6319-10 Standard Specification for | The physical dimensions of the subject device are | The physical dimensions of the predicate device are within the limits of | The physical dimensions of the reference device are | Same |
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| Nitrile Examination Gloves for Medical Applications | within the limits of the standard and the physical properties of the subject device met the requirements for tensile strength before and after aging. The subject device also met the requirement for elongation before and after aging. | the standard and the physical properties of the predicate device met the requirements for tensile strength before and after aging. The predicate device also met the requirement for elongation before and after aging. | within the limits of the standard and the physical properties of the reference device met the requirements for tensile strength before and after aging. The reference device also met the requirement for elongation before and after aging. |
|---|---|---|---|
| Clinical test | A 204 subject study was completed to evaluate whether the level of residual chemical additives in the subject device induced Type IV allergic contact sensitization by repetitive applications to the skin of normal healthy human volunteers using the Jordan-King modification of the Draize test as recommended by the FDA. Under the conditions of the study, the subject device was nonirritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. | Not previously tested | A 204 subject study was completed to evaluate whether the level of residual chemical additives in the reference device induced Type IV allergic contact sensitization by repetitive applications to the skin of normal healthy human volunteers using the Jordan-King modification of the Draize test as recommended by the FDA. Under the conditions of the study, the reference device was nonirritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. |
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SUMMARY OF NON-CLINICAL TESTING
| Brief description of non-clinical tests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Meets requirementsLength ≥230 mmPalm Width Size X-Small: 60 – 80 mmSmall: 70 - 90 mmMed: 85–105 mmLarge: 100 - 120 mmX-Large: 110-130 mmXX-Large: 120-140 mmFinger thickness ≥0.05 mmPalm thickness ≥0.05 mmCuff thickness ≥0.05 mm | Meets requirements | |
| Physical Properties | ASTM D 6319 | AQL 4.0Before AgingTensile Strength: ≥14 MPaUltimate elongation: ≥500%After AgingTensile Strength: ≥14 MPaUltimate elongation: ≥400% | Meets requirements | |
| Freedom from Pinholes | ASTM D 6319ASTM D 5151 | AQL 2.5%No leakage | Meets requirements | |
| Powder Free | ASTM D 6124ASTM D 6319 | ≤ 2 mg / glove | Meets requirements | |
| Test for irritation | ISO 10993, Part 23 | ≤ 0.4 | Under the conditions of the study, the device is not an irritant. | |
| Test for acute systemic toxicity | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals. | Under the conditions of the study, no evidence of acute systemic toxicity. | |
| Test for skin sensitization | ISO 10993, Part 10 | Grade < 1.0 | Under the conditions of the study, the device is not a sensitizer. |
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| Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | ASTM D6978-05 | No breakthrough for up to 240 minutes | 51 Drugs tested showed minimum breakthrough detection time up to 240 minutesCarmustine 3.3mg/ml minimum breakthrough detection time is 60 minutesFentanyl Citrate Injection (100 mcg/2 ml)Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution) minimum breakthrough detection time up to 240 minutes. |
|---|
SUMMARY OF CLINICAL TESTING
| Test | Description | Results |
|---|---|---|
| Modified DRAIZE-95 Test to Evaluate Low Dermatitis Potential of Medical Gloves | A 204 subject study was completed to evaluate whether the level of residual chemical additives in the subject device induced Type IV allergic contact sensitization by repetitive applications to the skin of normal healthy human volunteers using the Jordan-King modification of the Draize test as recommended by the FDA. | Under the conditions of the study, the subject device was nonirritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. |
Conclusion:
The conclusions drawn from the nonclinical and clinical tests demonstrate that the subject device, Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid, are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K160709.
§ 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.