(261 days)
The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, 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 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:
- Azacitidine (25 mg/ml)
- Bendamustine HCl (5 mg/ml)
- Bleomycin Sulfate (15 mg/ml)
- Bortezomib (1 mg/ml)
- Busulfan (6 mg/ml)
- Capecitabine (26 mg/ml)
- Carboplatin (10 mg/ml)
- Carfilzomib (2 mg/ml)
- Cetuximab (2 mg/ml)
- Cisplatin (1 mg/ml)
- Cladribine (1 mg/ml)
- Cyclophosphamide (20 mg/ml)
- Cytarabine HCl (100 mg/ml)
- Dacarbazine (10 mg/ml)
- Dactinomycin (0.5 mg/ml)
- Daunorubicin HCl (5 mg/ml)
- Decitabine (5 mg/ml)
- Docetaxel (10 mg/ml)
- Doxorubicin HCl (2 mg/ml)
- Epirubicin HCl (2 mg/ml)
- Etoposide (20 mg/ml)
- Fludarabine Phosphate (25 mg/ml)
- Fluorouracil (50 mg/ml)
- Fulvestrant (50 mg/ml)
- Gemcitabine HCl (38 mg/ml)
- Idarubicin HCl (1 mg/ml)
- Ifosfamide (50 mg/ml)
- Irinotecan HCl (20 mg/ml)
- Leuprolide Acetate (5 mg/ml)
- Mechlorethamine HCl (1 mg/ml)
- Melphalan HCl (5 mg/ml)
- Methotrexate (25 mg/ml)
- Mitomycin C (0.5 mg/ml)
- Mitoxantrone HCl (2 mg/ml)
- Oxaliplatin (5 mg/ml)
- Paclitaxel (6 mg/ml)
- Pemetrexed (25 mg/ml)
- Raltitrexed (0.5 mg/ml)
- Rituximab (10 mg/ml)
- Temsirolimus (25 mg/ml)
- Topotecan HCl (1 mg/ml)
- Trisenox (Arsenic Trioxide) (1 mg/ml)
- Vinblastine Sulfate (1 mg/ml)
- Vincristine (1 mg/ml)
- Vinorelbine Tartrate (10 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes:
- Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes.
- Thiotepa (10 mg/ml) No breakthrough up to 99.1 minutes.
- Warning- Not for use with Carmustine and ThioTEPA
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
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
- Chloroquine (50 mg/ml)
- Cyclosporin A (100 mg/ml)
- Cytovene (10 mg/ml)
- Retrovir (10 mg/ml)
- Triclosan (2 mg/ml)
- Zoledronic Acid (0.8 mg/ml)
The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable, 9.5" purple‐colored, chlorinated, nitrile, powder‐free, textured fingertip, ambidextrous, sterile patient examination gloves.
The provided text is a 510(k) clearance letter and summary for medical examination gloves, not an AI/ML device. Therefore, it does not contain information related to AI/ML specific acceptance criteria or study details such as:
- Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on the physical and chemical properties of the gloves and their resistance to various chemicals, using established ASTM and ISO standards for medical gloves.
However, I can extract the acceptance criteria and reported device performance for these medical gloves based on the provided document.
Analysis of Acceptance Criteria and Device Performance for Medical Gloves
The document details the non-clinical testing performed on the Halyard Purple Nitrile* Powder-Free Exam Gloves to demonstrate their safety and effectiveness. The acceptance criteria and the results of these tests are clearly outlined.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319 | Length ≥230 mm Palm Width Size Small: 70 - 90 mm Med: 85–105 mm Large: 100 - 120 mm Finger thickness ≥0.05 mm Palm thickness ≥0.05 mm Cuff thickness ≥0.05 mm | Meets requirements |
| Physical Properties (Tensile Strength & Elongation) | ASTM D 6319 | AQL 4.0 Before Aging: Tensile Strength: ≥14 MPa Ultimate elongation: ≥500% After Aging: Tensile Strength: ≥14 MPa Ultimate elongation: ≥400% | Meets requirements. The physical dimensions and properties (tensile strength before and after aging, and elongation before and after aging) met the requirements of the standard. |
| Freedom from Pinholes | ASTM D 6319, ASTM D 5151 | AQL 2.5% No leakage | Meets requirements. Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. |
| Sterility | ANSI/AAMI/ISO 11137 | 10⁻⁶ | 10⁻⁶ |
| Powder Free | ASTM D 6124, ASTM D 6319 | ≤ 2 mg / glove | Meets requirements. Residual powder on the subject device is an average of 0.4 mg/glove, which is within the powder-free limit of < 2 mg maximum powder per glove. |
| Test for Irritation | ISO 10993, Part 23 | Grade 1 (Implies non-irritant) | 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 (Implies non-sensitizer) | 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. | 51 Drugs tested showed minimum breakthrough detection time up to 240 minutes, including various concentrations of: Azacitidine, Bendamustine HCl, Bleomycin Sulfate, Bortezomib, Busulfan, Capecitabine, Carboplatin, Carfilzomib, Cetuximab, Cisplatin, Cladribine, Cyclophosphamide, Cytarabine HCl, Dacarbazine, Dactinomycin, Daunorubicin HCl, Decitabine, Docetaxel, Doxorubicin HCl, Epirubicin HCl, Etoposide, Fludarabine Phosphate, Fluorouracil, Fulvestrant, Gemcitabine HCl, Idarubicin HCl, Ifosfamide, Irinotecan HCl, Leuprolide Acetate, Mechlorethamine HCl, Melphalan HCl, Methotrexate, Mitomycin C, Mitoxantrone HCl, Oxaliplatin, Paclitaxel, Pemetrexed, Raltitrexed, Rituximab, Temsirolimus, Topotecan HCl, Trisenox (Arsenic Trioxide), Vinblastine Sulfate, Vincristine, Vinorelbine Tartrate.Exceptions (breakthrough detected in less than 100 minutes):- Carmustine (3.3 mg/ml): No breakthrough up to 44.5 minutes (Warning: Not for use).- Thiotepa (10 mg/ml): No breakthrough up to 99.1 minutes (Warning: Not for use). |
| Resistance to Permeation by Hazardous Drugs (Opioids) | ASTM D6978‐05 | No breakthrough for up to 240 minutes for listed drugs. | No breakthrough detected up to 240 minutes for:- Fentanyl Citrate Injection (100 mcg/2 ml)- Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
| Resistance to Permeation by Other Hazardous Drugs | ASTM D6978‐05 | No breakthrough for up to 240 minutes for listed drugs. | No breakthrough detected up to 240 minutes for:- Chloroquine (50 mg/ml)- Cyclosporin A (100 mg/ml)- Cytovene (10 mg/ml)- Retrovir (10 mg/ml)- Triclosan (2 mg/ml)- Zoledronic Acid (0.8 mg/ml) |
2. Sample size used for the test set and the data provenance
The document indicates that testing was performed according to specific ASTM and ISO standards (e.g., ASTM D6978-05, ASTM D5151, ASTM D6124, ASTM D6319, ISO 10993 Parts 10, 11, 23, ANSI/AAMI/ISO 11137). These standards inherently define the sample sizes and methodologies for testing. For instance, AQL (Acceptable Quality Level) values like 2.5% and 4.0% are mentioned for pinholes and physical properties, which dictates sampling plans for quality control.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of an AI/ML study. It is implied to be laboratory testing data generated prospectively for the purpose of this 510(k) submission, confirming product specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to the evaluation of medical gloves. The "ground truth" for glove performance is established by adherence to recognized international standards (ASTM, ISO, ANSI/AAMI) for physical, chemical permeation, and biocompatibility testing, rather than expert human interpretation of medical images or data. The testing is objective and quantitative.
4. Adjudication method for the test set
Not applicable. Testing involves standardized objective measurements, not subjective human evaluations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. MRMC studies are relevant for imaging diagnostics or other AI/ML applications where human interpretation is a key component. This document describes the testing of a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical product.
7. The type of ground truth used
The "ground truth" used is defined by the objective measurement criteria and methodologies specified in the cited international standards (ASTM D6978-05, ASTM D5151, ASTM D6319, ASTM D6124, ISO 10993, ANSI/AAMI/ISO 11137). For example, for chemical permeation, the ground truth is the chemical breakthrough time measured according to ASTM D6978-05. For biocompatibility, it's the observed biological reactions in animal models or in vitro tests compared to established toxicity/irritation/sensitization thresholds.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this document describes a physical medical device, not an AI/ML system.
FDA 510(k) Clearance Letter - K243172
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 18, 2025
O&M Halyard, Inc.
Caitlin Senter
Director, Global Regulatory Affairs
9120 Lockwood Blvd
Mechanicsville, Virginia 23116
Re: K243172
Trade/Device Name: Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles
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: September 30, 2024
Received: May 9, 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.
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"
Page 2
K243172 - Caitlin Senter Page 2
(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-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).
Page 3
K243172 - Caitlin Senter Page 3
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)
K243172
Device Name
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs;
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles
Indications for Use (Describe)
The Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs or Sterile Singles, 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 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:
- Azacitidine (25 mg/ml)
- Bendamustine HCl (5 mg/ml)
- Bleomycin Sulfate (15 mg/ml)
- Bortezomib (1 mg/ml)
- Busulfan (6 mg/ml)
- Capecitabine (26 mg/ml)
- Carboplatin (10 mg/ml)
- Carfilzomib (2 mg/ml)
- Cetuximab (2 mg/ml)
- Cisplatin (1 mg/ml)
- Cladribine (1 mg/ml)
- Cyclophosphamide (20 mg/ml)
- Cytarabine HCl (100 mg/ml)
- Dacarbazine (10 mg/ml)
- Dactinomycin (0.5 mg/ml)
- Daunorubicin HCl (5 mg/ml)
- Decitabine (5 mg/ml)
- Docetaxel (10 mg/ml)
- Doxorubicin HCl (2 mg/ml)
- Epirubicin HCl (2 mg/ml)
- Etoposide (20 mg/ml)
- Fludarabine Phosphate (25 mg/ml)
- Fluorouracil (50 mg/ml)
- Fulvestrant (50 mg/ml)
- Gemcitabine HCl (38 mg/ml)
- Idarubicin HCl (1 mg/ml)
- Ifosfamide (50 mg/ml)
- Irinotecan HCl (20 mg/ml)
- Leuprolide Acetate (5 mg/ml)
- Mechlorethamine HCl (1 mg/ml)
- Melphalan HCl (5 mg/ml)
- Methotrexate (25 mg/ml)
- Mitomycin C (0.5 mg/ml)
- Mitoxantrone HCl (2 mg/ml)
- Oxaliplatin (5 mg/ml)
- Paclitaxel (6 mg/ml)
- Pemetrexed (25 mg/ml)
FORM FDA 3881 (8/23) Page 1 of 2
Page 5
- Raltitrexed (0.5 mg/ml)
- Rituximab (10 mg/ml)
- Temsirolimus (25 mg/ml)
- Topotecan HCl (1 mg/ml)
- Trisenox (Arsenic Trioxide) (1 mg/ml)
- Vinblastine Sulfate (1 mg/ml)
- Vincristine (1 mg/ml)
- Vinorelbine Tartrate (10 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes:
- Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes.
- Thiotepa (10 mg/ml) No breakthrough up to 99.1 minutes.
- Warning- Not for use with Carmustine and ThioTEPA
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
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
- Chloroquine (50 mg/ml)
- Cyclosporin A (100 mg/ml)
- 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23) Page 2 of 2
Page 6
510(k) Summary for K243172
This summary of 510(k) K243172 is being submitted in accordance with 21 CFR 807.92.
| Date Summary was Prepared | June 18, 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* Powder‐Free Exam Gloves, Sterile Pairs;Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Singles |
| Device Submission Trade name and Description | Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs;Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Singles |
| Device Common Name | Medical Exam Gloves |
| Device Product Code and Classification Name | LZA Class I, 21 CFR §880.6250 Polymer 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 | Kimberly‐Clark Purple Nitrile XTRA* Sterile Powder‐Free Exam Glove (Chemotherapy Glove) ‐ 12 Sterile Pairs (K102032) |
| Reference Devices | Halyard Purple Nitrile, Powder‐Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K213929) |
| Subject Device Description | The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable, 9.5" purple‐colored, chlorinated, nitrile, powder‐free, textured fingertip, ambidextrous, sterile patient examination gloves. |
Page 7
| Indications for Use | Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, 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 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:- Azacitidine (25 mg/ml)- Bendamustine HCl (5 mg/ml)- Bleomycin Sulfate (15 mg/ml)- Bortezomib (1 mg/ml)- Busulfan (6 mg/ml)- Capecitabine (26 mg/ml)- Carboplatin (10 mg/ml)- Carfilzomib (2 mg/ml)- Cetuximab (2 mg/ml)- Cisplatin (1 mg/ml)- Cladribine (1 mg/ml)- Cyclophosphamide (20 mg/ml)- Cytarabine HCl (100 mg/ml)- Dacarbazine (10 mg/ml)- Dactinomycin (0.5 mg/ml)- Daunorubicin HCl (5 mg/ml)- Decitabine (5 mg/ml)- Docetaxel (10 mg/ml)- Doxorubicin HCl (2 mg/ml)- Epirubicin HCl (2 mg/ml)- Etoposide (20 mg/ml)- Fludarabine Phosphate (25 mg/ml)- Fluorouracil (50 mg/ml)- Fulvestrant (50 mg/ml)- Gemcitabine HCl (38 mg/ml)- Idarubicin HCl (1 mg/ml)- Ifosfamide (50 mg/ml)- Irinotecan HCl (20 mg/ml)- Leuprolide Acetate (5 mg/ml)- Mechlorethamine HCl (1 mg/ml)- Melphalan HCl (5 mg/ml)- Methotrexate (25 mg/ml)- Mitomycin C (0.5 mg/ml)- Mitoxantrone HCl (2 mg/ml)- Oxaliplatin (5 mg/ml)- Paclitaxel (6 mg/ml)- Pemetrexed (25 mg/ml)- Raltitrexed (0.5 mg/ml)- Rituximab (10 mg/ml)- Temsirolimus (25 mg/ml)- Topotecan HCl (1 mg/ml) |
Page 8
- Trisenox (Arsenic Trioxide) (1 mg/ml)
- Vinblastine Sulfate (1 mg/ml)
- Vincristine (1 mg/ml)
- Vinorelbine Tartrate (10 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes:
- Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes.
- Thiotepa (10 mg/ml) No breakthrough up to 99.1 minutes.
- Warning- Not for use with Carmustine and ThioTEPA
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
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
- Chloroquine (50 mg/ml)
- Cyclosporin A (100 mg/ml)
- Cytovene (10 mg/ml)
- Retrovir (10 mg/ml)
- Triclosan (2 mg/ml)
- Zoledronic Acid (0.8 mg/ml)
Page 9
| Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|
| FDA Product Code | LZA, LZC, OPJ, QDO | LZA, LZC | LZA, OPJ, QDO |
| FDA Classification | Class I | Class I | Class I |
| Regulation Number | 880.6250 | 880.6250 | 880.6250 |
| Common Name | Medical Exam Glove | Medical Exam Glove | Medical Exam Glove |
| Device Trade Name | Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Singles | Kimberly‐Clark Purple Nitrile XTRA* Sterile Powder‐Free Exam Glove (Chemotherapy Glove) ‐ 12 Sterile Pairs | Halyard Purple Nitrile, Powder‐Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
| Intended Use/Indications for Use | Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, 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 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: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 | A powder‐free 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. In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978‐05: The following drugs had NO breakthrough detected up to 240 minutes: Bleomycin Sulfate (15 mg/ml) Busulfan (6 mg/ml) Carboplatin (10 mg/ml) Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Cytarabine HCl (100 mg/ml) Dacarbazine (10 mg/ml) Daunorubicin HCl (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (Adriamycin) (2 mg/ml) | Halyard Purple Nitrile* Powder‐Free Exam Gloves, 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 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: Azacitidine (25 |
Page 10
| Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|
| mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carfilzomib (2 mg/ml) Cetuximab (2 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cytarabine HCl (100 mg/ml) Dacarbazine (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (2 mg/ml) Etoposide (20 mg/ml) Fludarabine Phosphate (25 mg/ml) Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine HCl (38 mg/ml) Idarubicin HCl (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan HCl (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 | Ellence (Epirubicin) (2 mg/ml) Etoposide (20 mg/ml) Fludarabine (25 mg/ml) Fluorouracil (adrucil) (50 mg/ml) Gemcitabine (38.0 mg/ml) | mg/ml) Bendamustine HCl (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 HCl (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) |
Page 11
| Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|
| mg/ml) Mitoxantrone HCl (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Trisenox (Arsenic Trioxide) (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine Tartrate (10 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes. Thiotepa (10 mg/ml) No breakthrough up to 99.1 minutes. Warning‐ Not for use with Carmustine and ThioTEPA 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 | 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) MitomycinC (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 | 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 |
Page 12
| Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|
| Fluid/Fentanyl Citrate Injection Mix 50/50 Solution The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes: Chloroquine (50 mg/ml) Cyclosporin A (100 mg/ml) Cytovene (10 mg/ml) Retrovir (10 mg/ml) Triclosan (2 mg/ml) Zoledronic Acid (0.8 mg/ml) | 55.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes. Warning‐ Not for use with Carmustine and ThioTEPA No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | 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 No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |
| Technological Characteristics | Colored, 9.5 inch, chlorinated, nitrile, powder‐free, textured fingertip, ambidextrous, sterile patient examination glove | Colored, 9.5 inch, chlorinated, nitrile, powder‐free, textured fingertip, ambidextrous, sterile patient examination glove | Colored, 9.5 inch, chlorinated, nitrile, powder‐free, textured fingertips, ambidextrous, non‐sterile patient examination glove |
| Sizes of gloves | S, M, L | S, M, L | XS, S, M, L, XL |
| Color | Purple | Purple | Purple |
Page 13
| Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|
| Texture | Textured fingertips | Textured fingertips | Textured fingertips |
| Sterility | Sterile | Sterile | Non‐Sterile |
| 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 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. |
| Standard | Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|---|
| 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: Azacitidine (25 mg/ml) | These chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978‐05: The following drugs had NO breakthrough detected up to 240 minutes: Bleomycin Sulfate (15 mg/ml) | The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) | Similar |
Page 14
| Standard | Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|---|
| Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carfilzomib (2 mg/ml) Cetuximab (2 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cytarabine HCl (100 mg/ml) Dacarbazine (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (2 mg/ml) Etoposide (20 mg/ml) Fludarabine Phosphate (25 mg/ml) Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine HCl (38 mg/ml) Idarubicin HCl (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan HCl (5 mg/ml) | Busulfan (6 mg/ml) Carboplatin (10 mg/ml) Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Cytarabine HCl (100 mg/ml) Dacarbazine (10 mg/ml) Daunorubicin HCl (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (Adriamycin) (2 mg/ml) Ellence (Epirubicin) (2 mg/ml) Etoposide (20 mg/ml) Fludarabine (25 mg/ml) Fluorouracil (adrucil) (50 mg/ml) Gemcitabine (38.0 mg/ml) | Bendamustine HCl (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 HCl (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) |
Page 15
| Standard | Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|---|
| Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCl (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Trisenox (Arsenic Trioxide) (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine Tartrate (10 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes. Thiotepa (10 mg/ml) No breakthrough up to 99.1 minutes. Warning‐ Not for use with Carmustine and ThioTEPA The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes: Chloroquine (50 mg/ml) Cyclosporin A (100 | 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) MitomycinC (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 | 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 |
Page 16
| Standard | Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|---|
| mg/ml) Cytovene (10 mg/ml) Retrovir (10 mg/ml) Triclosan (2 mg/ml) Zoledronic Acid (0.8 mg/ml) | 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 | 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 | ||
| 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) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | Not Previously Tested | No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | Different |
| 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 | 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 | 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 | Same |
Page 17
| Standard | Subject Device | Predicate Device (K102032) | Reference Device (K213929) | Comparison |
|---|---|---|---|---|
| meets the acceptance criteria for powder‐free. | for powder‐free | for powder‐free. | ||
| ASTM D6319‐10 Standard Specification for Nitrile Examination Gloves for Medical Applications | The physical dimensions of the subject device are 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 physical dimensions of the predicate device are within the limits of 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. | The physical dimensions of the reference device are within the limits of 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. | Same |
SUMMARY OF NON‐CLINICAL TESTING
| Brief description of non‐clinical tests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Length ≥230 mmPalm Width Size Small: 70 ‐ 90 mmMed: 85–105 mmLarge: 100 ‐ 120 mmFinger thickness ≥0.05 mmPalm thickness ≥0.05 mmCuff thickness ≥0.05 mm | Meets requirements |
Page 18
| Brief description of non‐clinical tests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| 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 | |
| Sterility | ANSI/AAMI/ISO 11137 | 10⁻⁶ | 10⁻⁶ | |
| Powder Free | ASTM D 6124ASTM D 6319 | ≤ 2 mg / glove | Meets requirements | |
| Test for irritation | ISO 10993, Part 23 | Grade 1 | 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. | |
| 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 44.5 minutes |
Page 19
| Brief description of non‐clinical tests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Thiotepa 10mg/ml minimum breakthrough detection time is 99.1 minutes. |
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject devices (Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles) are as safe, as effective, and performs as well as the legally marketed devices cleared under K102032.
§ 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.