Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate

K193555 · Ever Global (Vietnam) Enterprise Corp · LZC · Jun 4, 2020 · General Hospital

Device Facts

• Record ID: K193555
• Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
• Applicant: Ever Global (Vietnam) Enterprise Corp
• Product Code: LZC · General Hospital
• Decision Date: Jun 4, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable non-sterile nitrile examination glove; provides barrier protection for examiner's hands/fingers; prevents cross-contamination between patient and examiner. Tested for permeation resistance against 55 chemotherapy drugs and fentanyl citrate per ASTM D6978-05. Used in clinical settings by healthcare professionals. Output is physical barrier protection; informs clinical decision-making regarding safe handling of hazardous drugs. Benefits include protection of healthcare personnel from exposure to chemotherapy agents and fentanyl.

Clinical Evidence

Bench testing only. Testing included dimensions (ASTM D6319-10), physical properties (tensile strength/elongation), water leak/pinhole testing (ASTM D5151-06), powder residual (ASTM D6124-06), biocompatibility (ISO 10993-5, ISO 10993-10), and chemotherapy/fentanyl permeation resistance (ASTM D6978-05).

Technological Characteristics

Nitrile compound; non-sterile; powder-free. Dimensions: 230mm (short) or 300mm (long) length; 0.05mm min thickness. Physical properties: 14 MPa min tensile strength; 500% min elongation (before aging). Biocompatibility: passes ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs and fentanyl citrate.

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

• Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs (K190403)

Submission Summary (Full Text)

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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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

June 4, 2020

Ever Global (Vietnam) Enterprise Corp % Elizabeth Deng U.S. Representative Elizabeth Deng 5748 Eaglewood Place Ranch Cucamonga, California 91730

Re: K193555

Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZC, LZA, QDO Dated: April 29, 2020 Received: May 5, 2020

Dear Elizabeth Deng:

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.

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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 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-regulatoryassistance/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.

CAPT Elizabeth Claverie, M.S. 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

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# Ever Global (Vietnam) Enterprise Corporation

Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | | | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--|---------------------------------------------------------------------------------------------|
| Indications for Use | | | | |
| 510(k) Number (if known) | K193555 | | | |
| Device Name | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate | | | |
| Indications for Use (Describe) | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or<br>fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with<br>chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of<br>Resistance of Medical gloves to Permeation by Chemotherapy Drugs. | | | |
| Test Chemotherapy Drug | Concentration (mg/ml) | Minimum Breakthrough Detection Time (Min.) | | |
| 01 Arsenic Trioxide | 1.0 | > 240 | | |
| 02 Azacitidine (Vidaza) | 25.0 | > 240 | | |
| 03 Bendamustine HCl | 5.0 | > 240 | | |
| 04 Bleomycin Sulfate | 15.0 | > 240 | | |
| 05 Bortezomib (Velcade) | 1.0 | > 240 | | |
| 06 Busulfan | 6.0 | > 240 | | |
| 07 Carboplatin | 10.0 | > 240 | | |
| 08 Carfilzomib | 2.0 | > 240 | | |
| 09 Carmustine (BCNU) | 3.3 | 6.2 | | |
| 10 Cetuximab (Erbitux) | 2.0 | > 240 | | |
| 11 Chloroquine | 50.0 | > 240 | | |
| 12 Cisplatin | 1.0 | > 240 | | |
| 13 Cladribine | 1.0 | > 240 | | |
| 14 Cyclophosphamide | 20.0 | > 240 | | |
| 15 Cyclosporine A | 100.0 | > 240 | | |
| 16 Cytarabine mg/ml) | 100.0 | > 240 | | |
| 17 Cytovene (Ganciclovir) | 10.0 | > 240 | | |
| 18 Dacarbazine | 10.0 | > 240 | | |
| 19 Daunorubicin | 5.0 | > 240 | | |
| 20 Decitabine | 5.0 | > 240 | | |
| 21 Docetaxel | 10.0 | > 240 | | |
| 22 Doxorubicin Hydrochloride | 2.0 | > 240 | | |
| 23 Epirubicin (Ellence) | 2.0 | > 240 | | |
| 24 Etoposide | 20.0 | > 240 | | |
| 25 Fludarabine | 25.0 | > 240 | | |
| 26 Fluorouracil | 50.0 | > 240 | | |
| 27 Fulvestrant | 50.0 | > 240 | | |
| 28 Gemcitabine | 38.0 | > 240 | | |
| 29 Idarubicin | 1.0 | > 240 | | |
| 30 Ifosfamide | 50.0 | > 240 | | |
| 31 Irinotecan | 20.0 | > 240 | | |
| 32 Mechlorethamine HCl | 1.0 | > 240 | | |
| 33 Melphalan | 5.0 | > 240 | | |
| 34 Methotrexate | 25.0 | > 240 | | |
| 35 Mesna | 100.0 | > 240 | | |
| 36 Mitomycin C | 0.5 | > 240 | | |
| 37 Mitoxantrone | 2.0 | > 240 | | |
| FORM FDA 3881 (7/17) | Page 1 of 2 | PSC Publishing Services [phone] | | |

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# Ever Global (Vietnam) Enterprise Corporation

Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam

| 38 Oxaliplatin | 5.0 | > 240 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--------------|
| 39 Paclitaxel | 6.0 | > 240 |
| 40 Paraplatin | 10.0 | > 240 |
| 41 Pemetrexed | 25.0 | > 240 |
| 42 Pertuzumab | 30.0 | > 240 |
| 43 Raltitrexed | 0.5 | > 240 |
| 44 Retrovir | 10.0 | > 240 |
| 45 Rituximab | 10.0 | > 240 |
| 46 Temsirolimus | 25.0 | > 240 |
| 47 Thiotepa | 10.0 | 13.6 |
| 48 Topotecan HCl | 1.0 | > 240 |
| 49 Trastuzumab | 21.0 | > 240 |
| 50 Triclosan | 2.0 | > 240 |
| 51 Trisenox | 1.0 | > 240 |
| 52 Vinblastine | 1.0 | > 240 |
| 53 Vincristine Sulfate | 1.0 | > 240 |
| 54 Vinorelbine | 10.0 | > 240 |
| 55 Zoledronic Acid | 0.8 | > 240 |
| Warning: do not use with Carmustine and Thiotepa.<br>The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: | | |
| Carmustine (BCNU) | 3.3 mg/ml | 6.2 minutes |
| Thiotepa | 10.0 mg/ml | 13.6 minutes |
| Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate<br>Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. | | |
| Type of Use (Select one or both, as applicable) | | |
| Image: Checkbox | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Image: Unchecked checkbox | Prescription Use (Part 21 CFR 801 Subpart D) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |
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# 510(K) SUMMARY

## K193555

#### 1.0 Submitter:

| Submitter's name : | Ever Global (Vietnam) Enterprise Corp. | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter's address : | Long Thanh Industrial Zone<br>Taman Village Dong Nai Province, VN 810000 | |
| Phone number : | 84-61-3514022 | |
| Fax number : | 84 -61-3514023 | |
| Name of contact person: | Jerry Lin | |
| Summary Preparation Date: | May 27th,2020 | |
| 2.0 US Agent: | | |
| US representative name: | Elizabeth Deng | |
| Company address: | 5748 Eaglewood Place<br>Rancho Cuamonga, California<br>Rancho Cucamonga, CA 91739 | |
| Telephone number: | 909 4659188 | |
| Contact email: | [e-mail] | |
| 3.0 Name of the Device | | |
| Proprietary/Trade name: | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For<br>Use With Chemotherapy Drugs and Fentanyl Citrate | |
| Common Name: | Nitrile Examination Gloves | |
| Classification Name: | Patient Examination Glove | |
| Device Classification: | Class I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Product Code: | LZA, LZC, QDO | |
| 4.0 Predicate device | | |
| Device Name: | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For<br>Use With Chemotherapy Drugs | |
| Company name: | Ever Global (Vietnam) Enterprise Corp. | |
| 510(K) Number: | K190403 | |

#### 5.0 Device Description:

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

#### 6.0 Indication for use:

# Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.

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| No. | Test Chemotherapy Drug and<br>Concentration | Minimum Breakthrough<br>Detection Time (Min.) |
|-----|---------------------------------------------|-----------------------------------------------|
| 1 | Arsenic Trioxide (1.0 mg/ml) | > 240 |
| 2 | Azacitidine (Vidaza) (25.0 mg/ml) | > 240 |
| 3 | Bendamustine HCl (5.0 mg/ml) | > 240 |
| 4 | Bleomycin Sulfate (15.0 mg/ml) | > 240 |
| 5 | Bortezomib (Velcade) (1.0 mg/ml) | > 240 |
| 6 | Busulfan (6.0 mg/ml) | > 240 |
| 7 | Carboplatin (10.0 mg/ml) | > 240 |
| 8 | Carfilzomib (2.0 mg/ml) | > 240 |
| 9 | Carmustine (BCNU), (3.3 mg/ml) | 6.2 |
| 10 | Cetuximab (Erbitux) (2.0 mg/ml) | > 240 |
| 11 | Chloroquine (50.0 mg/ml) | > 240 |
| 12 | Cisplatin (1.0 mg/ml) | > 240 |
| 13 | Cladribine (1.0 mg/ml) | > 240 |
| 14 | Cyclophosphamide (20.0 mg/ml) | > 240 |
| 15 | Cyclosporine A (100.0 mg/ml) | > 240 |
| 16 | Cytarabine (100.0 mg/ml) | > 240 |
| 17 | Cytovene (Ganciclovir) (10.0 mg/ml) | > 240 |
| 18 | Dacarbazine (10.0 mg/ml) | > 240 |
| 19 | Daunorubicin (5.0 mg/ml) | > 240 |
| 20 | Decitabine (5.0 mg/ml) | > 240 |
| 21 | Docetaxel (10.0 mg/ml) | > 240 |
| 22 | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| 23 | Epirubicin (Ellence) (2.0 mg/ml) | > 240 |
| 24 | Etoposide (20.0 mg/ml) | > 240 |
| 25 | Fludarabine (25.0 mg/ml) | > 240 |
| 26 | Fluorouracil (50.0 mg/ml) | > 240 |
| 27 | Fulvestrant (50.0 mg/ml) | > 240 |
| 28 | Gemcitabine (38.0 mg/ml) | > 240 |
| 29 | Idarubicin (1.0 mg/ml) | > 240 |
| 30 | Ifosfamide (50.0 mg/ml) | > 240 |
| 31 | Irinotecan (20.0 mg/ml) | > 240 |
| 32 | Mechlorethamine HCl (1.0 mg/ml) | > 240 |
| 33 | Melphalan (5.0 mg/ml) | > 240 |
| 34 | Methotrexate (25 mg/ml) | > 240 |
| 35 | Mesna (100 mg/ml) | > 240 |
| 36 | Mitomycin C (0.5 mg/ml) | > 240 |
| 37 | Mitoxantrone (2.0 mg/ml) | > 240 |
| 38 | Oxaliplatin (5.0 mg/ml) | > 240 |
| 39 | Paclitaxel (6.0mg/ml) | > 240 |
| 40 | Paraplatin (10.0 mg/ml) | > 240 |
| 41 | Pemetrexed (25.0 mg/ml) | > 240 |
| 42 | Pertuzumab (30.0 mg/ml) | > 240 |
| 43 | Raltitrexed (0.5 mg/ml) | > 240 |
| 44 | Retrovir (10.0 mg/ml) | > 240 |
| 45 | Rituximab (10.0 mg/ml) | > 240 |
| 46 | Temsirolimus (25.0 mg/ml) | > 240 |
| 47 | Thiotepa (10.0 mg/ml) | 13.6 |
| 48 | Topotecan HCl (1.0 mg/ml) | > 240 |
| 49 | Trastuzumab (21.0 mg/ml) | > 240 |
| 50 | Triclosan (2.0 mg/ml) | > 240 |
| 51 | Trisenox (1.0 mg/ml) | > 240 |
| 52 | Vinblastine (1.0 mg/ml) | > 240 |
| 53 | Vincristine Sulfate (1.0 mg/ml) | > 240 |
| 54 | Vinorelbine (10.0 mg/ml) | > 240 |
| 55 | Zoledronic Acid (0.8 mg/ml) | > 240 |

Table 1 Tested for use with 55 chemotherapy drugs.

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Warning: do not use with Carmustine and Thiotepa.

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

| Carmustine (BCNU), 3.3 mg/ml | 6.2 minutes |
|------------------------------|--------------|
| Thiotepa, 10.0 mg/ml | 13.6 minutes |

Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected for up to 240 minutes.

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7.0 Comparison of Technological characteristics between the predicate and subject devices:

| Device Characteristic | Predicate Device | Subject Device | Comparison |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product name | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate | similar |
| 510(K) No. | K190403 | K193555 | N/A |
| Product Owner | Ever Global (Vietnam) Enterprise Corporation | Ever Global (Vietnam) Enterprise Corporation | same |
| Product Code | LZA, LZC | LZA, LZC, QDO | similar |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Intended Use | The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs And Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | similar |
| Powder free | Yes | Yes | same |
| Size | Small/ Medium/Large/X Large | X Small/ Small/Medium/Large/X Large | X Small is additional. |
| Single Use | YES | YES | same |
| Non-Sterile | No | No | same |
| Dimensions-Length | Complies with ASTM D6319-10 230 mm min. | Short cuff ≥230mm<br>Long cuff ≥300mm | Long cuff is additional. |
| Dimensions - Palm Width | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | Similar.<br>X Small is additional. |
| | Small<br>Medium<br>Large | X Small 70±10<br>Small 80±10<br>Medium 95 ±10<br>Large 110±10 | |

Table 2 Comparison of Technological Characteristics

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| Dimensions - Thickness | | Complies with ASTM D6319-10<br>Palm 0.05mm min.<br>Finger 0.05 mm min.<br>Cuff 0.05 mm min | Complies with ASTM D6319-10<br>Palm 0.05mm min.<br>Finger 0.05 mm min.<br>Cuff 0.05 mm min | same | |
|--------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------|
| Physical<br>Properties | | Tensile Strength:<br>Before Aging 14 MPa, min.<br>After Aging 14 MPa, min.<br>Elongation:<br>Before Aging 500% min.<br>After Aging 400% min. | Tensile Strength:<br>Before Aging 14 MPa, min.<br>After Aging 14 MPa, min.<br>Elongation:<br>Before Aging 500% min.<br>After Aging 400% min. | same | |
| Residual<br>powder | | Complies with ASTM D6319-10<br>< 2mg per glove | Complies with ASTM D6319-10<br>< 2mg per glove | same | |
| Freedom from<br>Holes | | In accordance with ASTM D6319-<br>10 and ASTM D5151- 06<br>(reapproved 2015), G-1, AQL 2.5 | In accordance with ASTM D6319-<br>10 and ASTM D5151-06<br>(reapproved 2015), G-1, AQL 2.5 | same | |
| Biocompatibility | | AAMI/ANSI/ISO 10993-10<br>Passes<br>Not a skin irritant & Not a skin<br>sensitizer | AAMI/ANSI/ISO 10993-10 &<br>AAMI/ANSI/ISO 10993-5<br>Passes<br>Not a skin irritant, Not a skin<br>sensitizer & No cytotoxicity<br>reaction | same | |
| Chemotherapy drugs tested | | Breakthrough Detection Time in Minutes | | Comparison | |
| | | Predicate<br>device | Subject Device | | |
| | Device Characteristic | K190403 | Short Cuff | Long Cuff | |
| Arsenic Trioxide (1.0 mg/ml) | | - | > 240 | | Different |
| Azacitidine (Vidaza) (25.0 mg/ml) | | - | > 240 | | Different |
| Bendamustine HCI (5.0 mg/ml) | | - | > 240 | | Different |
| | Bleomycin Sulfate (15.0 mg/ml) | - | > 240 | | Different |
| | Bortezomib (Velcade) (1.0 mg/ml) | - | > 240 | | Different |
| Busulfan (6.0 mg/ml) | | - | > 240 | | Different |
| Carboplatin (10.0 mg/ml) | | - | > 240 | | Different |
| Carfilzomib (2.0 mg/ml) | | - | > 240 | | Different |
| Carmustine (BCNU), (3.3 mg/ml) | | 6.2 | 21.5 | 37.5 | Similar |
| Cetuximab (Erbitux) (2.0 mg/ml) | | - | > 240 | | Different |
| Chloroquine (50.0 mg/ml) | | - | > 240 | | Different |
| | Cisplatin (1.0 mg/ml) | > 240 | > 240 | | Same |
| | Cladribine (1.0 mg/ml) | - | > 240 | | Different |
| | Cyclophosphamide (20.0 mg/ml) | > 240 | > 240 | | Same |
| | Cyclosporin A (100.0 mg/ml) | - | > 240 | | Different |
| | Cytarabine (100.0 mg/ml) | - | > 240 | | Different |
| Dacarbazine (DTIC), (10.0 mg/ml) | > 240 | > 240 | Same | | |
| Daunorubicin (5.0 mg/ml) | - | > 240 | Different | | |
| Decitabine (5.0 mg/ml) | - | > 240 | Different | | |
| Docetaxel (10.0 mg/ml) | - | > 240 | Different | | |
| Doxorubicin Hydrochloride (2.0mg/ml) | > 240 | > 240 | Same | | |
| Epirubicin (Ellence) (2.0 mg/ml) | - | > 240…