Who can help prepare an FDA 510(k) submission like Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

Q: Who is the manufacturer of Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)?

Harbour Health, LLC filed the 510(k) submission for Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) (K210944).

Q: What is the FDA product code for Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)?

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 Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)?

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

K210944 · Harbour Health, LLC · LZA · Apr 29, 2021 · General Hospital

Device Facts

Record ID	K210944
Device Name	Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Applicant	Harbour Health, LLC
Product Code	LZA · General Hospital
Decision Date	Apr 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1
Attributes	3rd-Party Reviewed

Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Cloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, blue nitrile examination glove; ambidextrous design with textured fingertips, straight fingers, and beaded cuff. Used in medical settings by examiners to prevent cross-contamination. Tested per ASTM D6978-05(2019) for resistance to chemotherapy drug permeation; provides barrier protection against specific chemotherapy agents. Output is physical barrier protection; healthcare providers use gloves during patient examinations and chemotherapy handling to reduce exposure risk. Benefits include reduced contamination risk and protection against hazardous drug exposure.

Clinical Evidence

Bench testing only. Evaluated per ASTM D6319-19 (physical properties), ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder), and ASTM D6978-05(2019) (chemotherapy drug permeation). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Design: Ambidextrous, textured fingertips, beaded cuff, straight fingers. Dimensions/Physical properties comply with ASTM D6319-19. Non-sterile, single-use, disposable. Chemotherapy resistance tested per ASTM D6978-05(2019).

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners to prevent contamination between patient and examiner. Suitable for use with chemotherapy drugs as specified in the permeation testing results.

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

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K182600)

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 29, 2021 Harbour Health LLC % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059 Re: K210944 Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: March 28, 2021 Received: March 30, 2021 Dear Dave Yungvirt: 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. Clarence W. Murray III, Ph.D. Acting 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) K210944 #### Device Name Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) #### Indications for Use (Describe) A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Cloves to Permeation by Chemotherapy Drugs. #### Chemotherapy Drug Permeation: | No. | Chemotherapy Drug Tested | Concentration | Breakthrough Detection Time (Minutes | |-----|----------------------------|-------------------------|--------------------------------------| | 1 | Busulfan | 6 mg/ml (6,000 ppm) | > 240 | | 2 | Carboplatin | 10 mg/ml (10,000 ppm) | > 240 | | 3 | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5* | | 4 | Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 | | 5 | Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 | | 6 | Cytarabine | 100 mg/ml (100,000 ppm) | > 240 | | 7 | Dacarbazine | 10.0 mg/ml (10,000 ppm) | > 240 | | 8 | Docetaxel | 10 mg/ml (10,000 ppm) | > 240 | | 9 | Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | > 240 | | 10 | Etoposide | 20.0 mg/ml (20,000 ppm) | > 240 | | 11 | Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 | | 12 | Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 | | 13 | Mechlorethamine HCI | 1 mg/ml (1,000 ppm) | > 240 | | 14 | Methotrexate | 25 mg/ml (25,000 ppm) | > 240 | | 15 | Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 | | 16 | Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 | | 17 | Paclitaxel | 6.0 mg/ml (6,000 ppm) | > 240 | | 18 | Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4* | | 19 | Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 | * WARNING: Not recommended for use with Carmustine and Thiotepa. The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times: | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5 minutes | |-------------------|-------------------------|--------------| | Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Harbour Health. The logo consists of a yellow symbol on the left and the words "HARBOUR HEALTH" on the right. The symbol is made up of two vertical lines with a dotted cross in the middle. # 510(k) Summary 510(k) Summary [As required by 21 CFR 807.92(c)] K210944 Submitter / 510(k) Sponsor Harbour Health LLC 4590 MacArthur Boulevard, Suite 500 Newport Beach, CA 92660 Registration Number: 3017153466 Contact Person Jared Koenig CEO Tel: (949) 629-5068 Email: jared@factorydirecthealth.com Summary Preparation Date 19 April 2021 Type of 510(k) Submission Traditional Device Name / Classification Trade Name: Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) Common Name: Non-powdered patient examination glove Classification Name: Medical Gloves with Chemotherapy Labeling Claims - Test For Use with Chemotherapy Drugs Product Code: LZA, LZC, OPJ Review Panel: General Hospital Regulatory Class: Class 1 Regulation Number: 21 CFR 880.6250 Predicate Device Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Device Name: Drugs (Blue) 510(k) Number: K182600 510(k) Owner: Better Care Plastic Technology Co., Ltd Device Description The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a non-sterile, single use only, disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are nitrile, powder free, and blue in color. They feature an ambidextrous design with textured fingertips, Harbour Health LLC 4590 MacArthur Boulevard. Suite 500 Newport Beach, CA 92660 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Harbour Health. The logo consists of a stylized "H" formed by two vertical lines with a series of dots in the center, resembling a plus sign. To the right of the symbol, the words "HARBOUR HEALTH" are written in a simple, sans-serif font. straight fingers, and a beaded cuff. The gloves are available in sizes small, medium, large, and extralarge, packaged in a chipboard box. The gloves are designed and manufactured in accordance with ASTM D6319-19 and tested for use with chemotherapy drugs per ASTM D6978-05(2019). Indications for Use A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug Tested | Concentration | Breakthrough Detection Time (Minutes) | |----------------------------|-------------------------|------------------------------------------| | Busulfan | 6 mg/ml (6,000 ppm) | > 240 | | Carboplatin | 10 mg/ml (10,000 ppm) | > 240 | | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5* | | Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 | | Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 | | Cytarabine | 100 mg/ml (100,000 ppm) | > 240 | | Dacarbazine | 10.0 mg/ml (10,000 ppm) | > 240 | | Docetaxel | 10 mg/ml (10,000 ppm) | > 240 | | Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | > 240 | | Etoposide | 20.0 mg/ml (20,000 ppm) | > 240 | | Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 | | Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 | | Mechlorethamine HCI | 1 mg/ml (1,000 ppm) | > 240 | | Methotrexate | 25 mg/ml (25,000 ppm) | > 240 | | Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 | | Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 | | Paclitaxel | 6.0 mg/ml (6,000 ppm) | > 240 | | Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4* | | Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 | Table 1: Chemotherapy Drug Permeation * WARNING: Not recommended for use with Carmustine and Thiotepa. The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times: | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5 minutes | |-------------------|-------------------------|--------------| | Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4 minutes | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Harbour Health. The logo consists of a yellow symbol on the left and the words "HARBOUR HEALTH" on the right. The symbol is made up of two vertical lines with a plus sign in the middle, formed by small yellow dots. ## Summary of Technological Characteristics | Characteristic | Proposed Device | Predicate Device | Comparison Analysis | |----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Device Name | Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | N/A | | 510(k) Reference | K210944 | K182600 | N/A | | Product Owner | Harbour Health LLC | Better Care Plastic Technology Co., Ltd. | N/A | | Product Code | LZA, LZC, OPJ | LZA, LZC | Similar | | Intended Use | The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The proposed device was tested for use with chemotherapy drugs per ASTM D6978-05(2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2013) and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation. | Same | | Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Material | Nitrile | Nitrile | Same | | Color | Blue | Blue | Same | | Design Features | Ambidextrous Textured fingertips Beaded cuff Straight fingers | Ambidextrous | Similar | | Sizes | Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large | Same | | Rx vs OTC | OTC | OTC | Same | | Sterile vs Non- Sterile | Non-Sterile | Non-Sterile | Same | | Disposable vs Non- Disposable | Disposable | Disposable | Same | | Single Use vs Reusable | Single Use | Single Use | Same | | Characteristic | Proposed Device | Predicate Device | Comparison Analysis | | Dimensions - Width | Complies with ASTM D6319-19 Small: 80 ± 10mm Medium: 95 ± 10mm Large: 110 ± 10mm Extra Large: 120 ± 10mm | Complies with ASTM D6319-19 Extra Small: 70 ± 10mm Small: 80 ± 10mm Medium: 95 ± 10mm Large: 110 ± 10mm Extra Large: 120 ± 10mm | Same | | Dimensions - Thickness | Complies with ASTM D6319-19 Palm: 0.05mm min. Finger: 0.05mm min. | Complies with ASTM D6319-19 Palm: 0.05mm min. Finger: 0.05mm min. | Same | | Dimensions - Length | Complies with ASTM D6319-19 Small: 220mm min. Medium/Large/Extra Large: | Complies with ASTM D6319-19 Small: 220mm min. Medium/Large/Extra Large: 230mm min. | Similar | | Physical Properties - Tensile Strength | Complies with ASTM D6319-19 Before Aging: $\ge$ 14 MPa, min. After Aging: $\ge$ 14 MPa, min. | Complies with ASTM D6319-19 Before Aging: $\ge$ 14 MPa, min. After Aging: $\ge$ 14 MPa, min. | Same | | Physical Properties - Elongation | Complies with ASTM D6319-19 Before Aging: 500% min. After Aging: 400% min. | Complies with ASTM D6319-19 Before Aging: 500% min. After Aging: 400% min. | Same | | Freedom from Holes | Complies with ASTM D6319-19 and ASTM D5151-19 G-1, AQL 2.5 | In accordance with ASTM D 5151- 06, following ASTM D6319- 10, G-1, AQL 2.5 | Similar | | Powder or Powder Free | Powder Free | Powder Free | Same | | Residual Powder | Complies with ASTM D6319-19 $\le$ 2 mg per glove | In accordance with ASTM D6124- 06 (Reapproved 2017), following ASTM D6319-10 $\le$ 2 mg per glove | Same | | Characteristic | Proposed Device | Predicate Device | Comparison Analysis | | Biocompatibility | Complies with ANSI/AAMI/ISO 10993-5 (2009) • Under the conditions of the study, the device is potentially cytotoxic. Complies with ANSI/AAMI/ISO 10993-10 (2010) • Under the conditions of the study, the device is a non- irritant and a non-sensitizer. Complies with ANSI/AAMI/ISO 10993-11 (2017) • Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ANSI/AAMI/ISO 10993-10 (2010) • Not a skin irritant • Not a skin sensitizer | Similar | | Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as tested per ASTM D6978-05 (2019) | | | | | Bleomycin | Not tested | 15.0 mg/ml (15,000 ppm) > 240 minutes | Different | | Busulfan | 6.0 mg/ml (6,000 ppm) > 240 minutes | 6.0 mg/ml (6,000 ppm) > 240 minutes | Same | | Carboplatin | 10.0 mg/ml (10,000 ppm) > 240 minutes | 10.0 mg/ml (10,000 ppm) > 240 minutes | Same | | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) 14.5 minutes | 3.3 mg/ml (3,300 ppm) 11.0 minutes | Same | | Chloroquine | Not tested | 50.0 mg/ml (50,000 ppm) > 240 minutes | Different | | Cisplatin | 1 mg/ml (1,000 ppm) > 240 minutes | 1 mg/ml (1,000 ppm) > 240 minutes | Same | | Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) > 240 minutes | 20 mg/ml (20,000 ppm) > 240 minutes | Same | | Cyclosporin | Not tested | 100.0 mg/ml (100,000 ppm) > 240 minutes | Different | | Cytarabine | 100.0 mg/ml (100,000 ppm) > 240 minutes | 100.0 mg/ml (100,000 ppm) > 240 minutes | Same | | Dacarbazine | 10 mg/ml (10,000 ppm) > 240 minutes | 10 mg/ml (10,000 ppm) > 240 minutes | Same | | Daunorubicin | Not tested | 5.0 mg/ml (5,000 ppm) > 240 minutes | Different | | Docetaxel | 10.0 mg/ml (10,000 ppm) > 240 minutes | 10.0 mg/ml (10,000 ppm) > 240 minutes | Same | | Characteristic | Proposed Device | Predicate Device | Comparison Analysis | | Doxorubicin HCI | 2 mg/ml (2,000 ppm) > 240 minutes | 2 mg/ml (2,000 ppm) > 240 minutes | Same | | Epirubicin (Ellence) | Not tested | 2.0 mg/ml (2,000 ppm) > 240 minutes | Different | | Etoposide | 20 mg/ml (20,000 ppm) > 240 minutes | 20 mg/ml (20,000 ppm) > 240 minutes | Same | | Fludarabine | Not tested | 25.0 mg/ml (25,000 ppm) > 240 minutes | Different | | Fluorouracil | 50 mg/ml (50,000 ppm) > 240 minutes | 50 mg/ml (50,000 ppm) > 240 minutes | Same | | Gemcitabine (Gemzar) | Not tested | 38.0 mg/ml (38,000 ppm) > 240 minutes | Different | | Idarubicin | Not tested | 1.0 mg/ml (1,000 ppm) > 240 minutes | Different | | Ifosfamide | 50.0 mg/ml (50,000 ppm) > 240 minutes | 50.0 mg/ml (50,000 ppm) > 240 minutes | Same | | Irinotecan | Not tested | 20.0 mg/ml (20,000 ppm) > 240 minutes | Different | | Mechlorethamine HCI | 1.0 mg/ml (1,000 ppm) > 240 minutes | 1.0 mg/ml (1,000 ppm) > 240 minutes | Same | | Melphalan | Not tested | 5.0 mg/ml (5,000 ppm) > 240 minutes | Different | | Methotrexate | 25 mg/ml (25,000 ppm) > 240 minutes | 25 mg/ml (25,000 ppm) > 240 minutes | Same | | Mitomycin C | 0.5 mg/ml (500 ppm) > 240 minutes | 0.5 mg/ml (500 ppm) > 240 minutes | Same | | Mitoxantrone | 2.0 mg/ml (2,000 ppm) > 240 minutes | 2.0 mg/ml (2,000 ppm) > 240 minutes | Same | | Oxaliplatin | Not tested | 2.0 mg/ml (2,000 ppm) > 240 minutes | Different | | Paclitaxel | 6 mg/ml (6,000 ppm) > 240 minutes | 6 mg/ml (6,000 ppm) > 240 minutes | Same | | Paraplatin | Not tested | 10.0 mg/ml (10,000 ppm) > 240 minutes | Different | | Retrovir | Not tested | 10.0 mg/ml (10,000 ppm) > 240 minutes | Different | | Rituximab | Not tested | 10.0 mg/ml (10,000 ppm) > 240 minutes | Different | | Thiotepa | 10 mg/ml (10,000 ppm) 47.4 minutes…

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

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Device Story

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Technological Characteristics

Indications for Use

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Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

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