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 · O&M Halyard, Inc. · LZA · Sep 27, 2024 · General Hospital

Device Facts

• Record ID: K241909
• Device Name: 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
• Applicant: O&M Halyard, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Sep 27, 2024
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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 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) 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 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) (50 mcg/2 ml)

Device Story

Disposable, non-sterile, 9.5-inch purple nitrile examination gloves; textured fingertips; ambidextrous. Designed to prevent cross-contamination between patient and examiner. Tested per ASTM D6978-05 for permeation resistance against various chemotherapy drugs and opioids (Fentanyl Citrate). Used in clinical settings by healthcare professionals. Provides barrier protection; reduces risk of exposure to hazardous drugs. Low dermatitis potential claim supported by clinical sensitization testing.

Clinical Evidence

Clinical prospective study (n=204) using Jordan-King modification of the Draize test to evaluate Type IV allergic contact sensitization. Results: device was non-irritating and showed no clinical evidence of residual chemical additives inducing Type IV allergy.

Technological Characteristics

Material: Nitrile; powder-free; chlorinated. Dimensions: 9.5 inch length; textured fingertips. Sizes: XS, S, M, L, XL, XXL. Biocompatibility: Tested per ISO 10993-10 (sensitization), ISO 10993-11 (systemic toxicity), and ISO 10993-23 (irritation). Non-sterile.

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs, Fentanyl Citrate, and simulated gastric acid per ASTM D6978-05. Contraindicated for use with Carmustine and Thiotepa.

Regulatory Classification

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.

Predicate 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)

Reference Devices

• Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution (K213937)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 27, 2024

O&M Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K241909

Trade/Device Name: 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 Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: June 30, 2024 Received: July 1, 2024

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.

{1}------------------------------------------------

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 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-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 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-device-advicecomprehensive-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-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-regulatory

{2}------------------------------------------------

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K241909

#### Device Name

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

### Indications for Use (Describe)

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 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) 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) FORM FDA 3881 (8/23)

{4}------------------------------------------------

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

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) (50 mcg/2 ml)

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)

### 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a light gray color.

# 510(k) Summary for K241909

This summary of 510(k) K241909 is being submitted in accordance with 21 CFR 807.92.

| Date Summary was Prepared | September 27, 2024 |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | O & M Halyard, Inc.<br>9120 Lockwood Boulevard<br>Mechanicsville, VA 231161 |
| Primary Contact for<br>this 510(k) Submission | Caitlin Senter, MS, RAC<br>Tel: [phone]<br>Email: [e-mail] |
| Marketed Device Trade Name | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,<br>Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric<br>Acid and Fentanyl in Simulated Gastric Acid |
| Device Submission Trade name<br>and Description | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,<br>Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric<br>Acid and Fentanyl in Simulated Gastric Acid |
| Device Common Name | Medical Exam Gloves |
| Device Product Code<br>and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove<br>LZC Class I, 21 CFR §880.6250 medical glove, specialty<br>OPJ Class I, 21 CFR §880.6250 Medical Gloves with Chemotherapy Labeling<br>Claims - Test For Use with Chemotherapy Drugs<br>QDO Class I, 21 CFR §880.6250 Fentanyl and Other Opioid Protection Glove |
| Predicate Device | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with<br>Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in<br>Simulated Gastric Acid (K213929) |
| Reference Device | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves<br>Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated<br>Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution (K213937) |
| Subject Device Description | The Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis<br>Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate,<br>Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable,<br>9.5 " purple-colored, chlorinated, nitrile, powder-free, textured fingertip,<br>ambidextrous, non-sterile patient examination gloves. |
| Indications for Use | 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:<br><br>The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:<br>Azacitidine (25 mg/ml)<br>Bendamustine HCl (5 mg/ml)<br>Bleomycin Sulfate (15 mg/ml)<br>Bortezomib (1 mg/ml)<br>Busulfan (6 mg/ml)<br>Capecitabine (26 mg/ml)<br>Carboplatin (10 mg/ml)<br>Carlzomib (2 mg/ml)<br>Cetuximab (2 mg/ml)<br>Chloroquine (50 mg/ml)<br>Cisplatin (1 mg/ml)<br>Cladribine (1 mg/ml)<br>Cyclophosphamide (20 mg/ml)<br>Cyclosporin A (100 mg/ml)<br>Cytarabine (Cytosine) (100 mg/ml)<br>Cytovene (Ganciclovir) (10 mg/ml)<br>Dacarbazine (DTIC) (10 mg/ml)<br>Dactinomycin (0.5 mg/ml)<br>Daunorubicin HCl (5 mg/ml)<br>Decitabine (5 mg/ml)<br>Docetaxel (10 mg/ml)<br>Doxorubicin HCl (2 mg/ml)<br>Epirubicin HCl (Ellence) (2 mg/ml)<br>Etoposide (Toposar) (20 mg/ml)<br>Fludarabine (25 mg/ml)<br>5-Fluorouracil (50 mg/ml)<br>Fulvestrant (50 mg/ml)<br>Gemcitabine (38 mg/ml)<br>Idarubicin (1 mg/ml)<br>Ifosfamide (50 mg/ml)<br>Irinotecan HCl (20 mg/ml)<br>Leuprolide Acetate Salt (5 mg/ml)<br>Mechlorethamine HCl (1 mg/ml)<br>Melphalan (5 mg/ml)<br>Methotrexate (25 mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone (2 mg/ml)<br>Oxaliplatin (5 mg/ml)<br>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 | |
| | |
| 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 | |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in a light gray color. The font is sans-serif and the overall design is clean and professional.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a gray color. The ampersand symbol is placed between the two words.

| Technological Characteristics Comparison Table | | | | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…