Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)

Q: Who is the manufacturer of Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)?

Nephron Nitrile, LLC submitted the Special clearance for Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K231349).

Q: What is the FDA product code for Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

Q: What is the regulatory pathway for Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)?

510(k) clearance (submission type: Special).

K231349 · Nephron Nitrile, LLC · LZA · Jun 6, 2023 · General Hospital

Device Facts

Record ID	K231349
Device Name	Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
Applicant	Nephron Nitrile, LLC
Product Code	LZA · General Hospital
Decision Date	Jun 6, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.6250
Device Class	Class 1

Intended Use

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves; blue color; fingertip textured; ambidextrous; beaded cuff. Used by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against chemotherapy drugs and fentanyl per ASTM D6978-05 (2019). Provides barrier protection during clinical examinations. Benefits include protection against patient-to-examiner contamination and specific chemical exposure during handling of chemotherapy agents and fentanyl.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: Nitrile (NBR). Form: Powder-free, fingertip textured, beaded cuff, ambidextrous. Standards: ASTM D6319-19 (specifications), ASTM D6978-05 (2019) (chemotherapy/fentanyl permeation), ASTM D5151-19 (holes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-23 (irritation), ISO 10993-10 (sensitization), ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs and fentanyl.

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

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) (K223559)

Related Devices

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K211547 — Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) · Edma Group, LLC · Jul 15, 2021
K232764 — Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate · Eco Medi Glove Sdn. Bhd. · Feb 7, 2024
K210944 — Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) · Harbour Health, LLC · Apr 29, 2021

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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. June 6, 2023 Nephron Nitrile, LLC. Lou Kennedy Chief Executive Officer 4777 12th Street Extension West Columbia, South Carolina 29172 Re: K231349 Trade/Device Name: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) 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: May 9, 2023 Received: May 9, 2023 Dear Lou Kennedy: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Bifeng Qian -S Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K231349 #### Device Name Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) Indications for Use (Describe) Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) 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: | Bleomycin Sulfate (15.0 mg/ml) | Doxorubicin HCl (2.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) | |--------------------------------|-----------------------------|---------------------------------| | Busulfan (6.0 mg/ml) | Epirubicin HCl (2.0 mg/ml) | Melphalan (5.0 mg/ml) | | Carboplatin (10.0 mg/ml) | Etoposide (20.0 mg/ml) | Methotrexate (25.0 mg/ml) | | Cisplatin (1.0 mg/ml) | Fludarabine (25.0 mg/ml) | Mitomycin C (0.5 mg/ml) | | Cyclophosphamide (20.0 mg/ml) | Fluorouracil (50.0 mg/ml) | Mitoxantrone HCl (2.0 mg/ml) | | Cytarabine (100.0 mg/ml) | Gemcitabine (38.0 mg/ml) | Paclitaxel (6.0 mg/ml) | | Dacarbazine (10.0 mg/ml) | Idarubicin HCl (1.0 mg/ml) | Rituximab (10.0 mg/ml) | | Daunorubicin HCl (5.0 mg/ml) | Ifosfamide (50.0 mg/ml) | Trisenox (1.0 mg/ml) | | Docetaxel (10.0 mg/ml) | Irinotecan (20.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) | The following chemotherapy drugs have low permeation times: Thiotepa (10.0 mg/ml) : 128.1 minutes Carmustine (3.3 mg/ml) : 33.8 minutes Warning: Not for Use with: Carmustine, Thiotepa The tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL). Permeation: no breakthrough up to 240 minutes Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ ### A. APPLICANT INFORMATION | 510(K) Owner's Name | Nephron Nitrile, LLC. | |---------------------|---------------------------------------------------------| | Address | 4777 12th Street Extension, West Columbia, SC 29172. | | Phone | 844-937-3888 | | Fax | 1-803-926-9853 | | E-mail | lkennedy@nephronpharm.com | | Contact Person | Lou Kennedy | | Designation | Chief Executive Officer | | Contact Number | 1-803-569-3110 | | Contact Email | lkennedy@nephronpharm.com | | Date Prepared | 31 May 2023 | ### B. DEVICE IDENTIFICATION | Name of the device | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------| | Product proprietary or trade name | Nephron Nitrile | | Common or usual name | Nitrile Examination Gloves (Tested for use with Chemotherapy drugs and Fentanyl) | | 510(k) Number | K231349 | | Classification name | Patient Examination Glove, Specialty | | Device Classification | Class-1 | | Product Code | LZA, LZC, OPJ, QDO | | Regulation Number | 21 CFR 880.6250 | | Review Panel | General Hospital | ### C. PREDICATE DEVICE | Predicate Device | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | |------------------|-------------------------------------------------------------------------------------------------------| | 510(k) Number | K223559 | | Regulatory Class | Class-1 | | Product code | LZA, LZC, OPJ | | Owner | Nephron Nitrile, LLC. | {4}------------------------------------------------ #### D. DESCRIPTION OF THE DEVICE: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19. Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only. Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) with sizes Medium, Large, X-Large and XX-Large are included in the submission. ### E. INDICATION FOR USE OF THE DEVICE: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl in accordance with ASTM D6978-05 (2019) 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 | | | The tested | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | 240 minutes: | | | Opioid is: | | Bleomycin Sulfate (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (10.0 mg/ml) Daunorubicin HCl (5.0 mg/ml) Docetaxel (10.0 mg/ml) | Doxorubicin HCl (2.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (38.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml) Rituximab (10.0 mg/ml) Trisenox (1.0 mg/ml) Vincristine Sulfate (1.0 mg/ml) | Fentanyl Citrate Injection (100 mcg/2 mL) Permeation: no breakthrough up to 240 minutes | | The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes Warning: Not for Use with: Carmustine, Thiotepa | | | minutes | {5}------------------------------------------------ ### F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison | | |-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | PREDICATE | SUBJECT | | | | | 510(K) Number | --- | K223559 | K231349 | | | | Name of device | --- | Nephron Nitrile Powder- Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Different: Except for the addition of Fentanyl for subject device, it is identical | | | Product Code | --- | LZA, LZC, OPJ | LZA, LZC, OPJ, QDO | Different: Added one product code | | | Indication for use | --- | Nephron Nitrile Powder- Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Different: Except for the addition of Fentanyl for subject device, it is identical Note: Adding the Fentanyl to the indication does not affect the intended use. | | | Regulation Number | --- | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical | | | Material | --- | Nitrile | Nitrile | Identical | | | Color | --- | Blue | Blue | Identical | | | Size | --- | M, L, XL, XXL | M, L, XL, XXL | Identical | | | Single Use | --- | Single-use | Single-use | Identical | | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison | | | | | PREDICATE | SUBJECT | | | | 510(K) Number | --- | K223559 | K231349 | | | | Sterile/non sterile | --- | Non Sterile | Non Sterile | Identical | | | Rx Only or OTC | --- | OTC | OTC | Identical | | | Dimensions - Length | ASTM D6319-19 | Minimum 230 mm (sizes M - XXL) | Minimum 230 mm (sizes M - XXL) | Identical | | | Dimensions - Width | ASTM D6319-19 | M: 95±10 mm L: 110±10 mm XL: 120±10 mm XXL: 130±10 mm | M: 95±10 mm L: 110±10 mm XL: 120±10 mm XXL: 130±10 mm | Identical | | | Physical Properties- Tensile Strength | ASTM D63192019 | Before aging 14MPa, min | Before aging 14MPa, min | Identical | | | | | After aging 14MPa, min | After aging 14MPa, min | Identical | | | Physical Properties- Ultimate Elongation | ASTM D63192019 | Before aging 500%, min | Before aging 500%, min | Identical | | | | | After aging 400%, min | After aging 400%, min | Identical | | | Thickness | ASTM D6319-19 | Palm: Minimum 0.05 mm Finger: Minimum 0.05 mm | Palm: Minimum 0.05 mm Finger: Minimum 0.05 mm | Identical | | | Powder Free Residue | ASTM D6319- 19 | ≤ 2 mg per glove | ≤ 2 mg per glove | Identical | | | Freedom from holes | ASTM D5151- 2019 | In accordance with ASTM D 5151-19, following ASTM D6319-19, G-I, AQL 2.5 | In accordance with ASTM D 5151-19, following ASTM D6319- 19, G-I, AQL 2.5 | Identical | | | Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time | ASTM D6978- 05 (2019) | Bleomycin Sulfate 15 mg/ml (15,000 ppm) >240 Minutes | Bleomycin Sulfate 15 mg/ml (15,000 ppm) >240 Minutes | Identical | | | | | Busulfan 6 mg/ml (6,000 ppm) >240 Minutes | Busulfan 6 mg/ml (6,000 ppm) >240 Minutes | Identical | | | | | Carboplatin 10 mg/ml (10,000 ppm) >240 Minutes | Carboplatin 10 mg/ml (10,000 ppm) >240 Minutes | Identical | | | | | Carmustine 3.3 mg/ml (3,300 ppm) 33.8 Minutes | Carmustine 3.3 mg/ml (3,300 ppm) 33.8 Minutes | Identical | | | | | Cisplatin 1 mg/ml (1,000 ppm) >240 Minutes | Cisplatin 1 mg/ml (1,000 ppm) >240 Minutes | Identical | | | CHARACTERISTICS STANDARDS | | DEVICE PERFORMANCE | PREDICATE | SUBJECT | Comparison | | 510(K) Number | --- | K223559 | K231349 | | | | | | Cyclophosphamide 20 mg/ml (20,000 ppm) >240 Minutes | Cyclophosphamide 20 mg/ml (20,000 ppm) >240 Minutes | Identical | | | | | Cytarabine 100 mg/ml (100,000 ppm) >240 Minutes | Cytarabine 100 mg/ml (100,000 ppm) >240 Minutes | Identical | | | | | Dacarbazine 10 mg/ml (10,000 ppm) >240 Minutes | Dacarbazine 10 mg/ml (10,000 ppm) >240 Minutes | Identical | | | | | Daunorubicin HCl 5 mg/ml (5,000 ppm) >240 Minutes | Daunorubicin HCl 5 mg/ml (5,000 ppm) >240 Minutes | Identical | | | | | Docetaxel 10 mg/ml (10,000 ppm) >240 Minutes | Docetaxel 10 mg/ml (10,000 ppm) >240 Minutes | Identical | | | | | Doxorubicin HCl 2 mg/ml (2,000 ppm) >240 Minutes | Doxorubicin HCl 2 mg/ml (2,000 ppm) >240 Minutes | Identical | | | | | Epirubicin HCl 2 mg/ml (2,000 ppm) >240 Minutes | Epirubicin HCl 2 mg/ml (2,000 ppm) >240 Minutes | Identical | | | | | Etoposide 20 mg/ml (20,000 ppm) >240 Minutes | Etoposide 20 mg/ml (20,000 ppm) >240 Minutes | Identical | | | | | Fludarabine 25 mg/ml (25,000 ppm) >240 Minutes | Fludarabine 25 mg/ml (25,000 ppm) >240 Minutes | Identical | | | | | Fluorouracil 50 mg/ml (50,000 ppm) >240 Minutes | Fluorouracil 50 mg/ml (50,000 ppm) >240 Minutes | Identical | | | | | Gemcitabine 38 mg/ml (38,000 ppm) >240 Minutes | Gemcitabine 38 mg/ml (38,000 ppm) >240 Minutes | Identical | | | | | Idarubicin HCl 1 mg/ml (1,000 ppm) >240 Minutes…