SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove

K211003 · Showa Best Glove, Inc. · LZA · Jan 19, 2022 · General Hospital

Device Facts

• Record ID: K211003
• Device Name: SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
• Applicant: Showa Best Glove, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Jan 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

Device Story

Disposable, non-sterile, blue nitrile butadiene rubber medical examination glove; worn by clinicians to prevent cross-contamination during patient examinations. Device provides barrier protection; tested for permeation resistance against 29 chemotherapy drugs per ASTM D6978-05. Used in clinical settings; operated by healthcare professionals. Output is physical barrier protection; informs clinical decision-making by enabling safe handling of chemotherapy agents. Benefits include reduced risk of exposure to hazardous drugs and patient-clinician contamination.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including ASTM D6319-10 (dimensions, tensile strength, elongation, freedom from holes, residual powder) and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing (ISO 10993-10, ISO 10993-11) confirmed the device is not a primary skin irritant, not a contact sensitizer, and not toxic.

Technological Characteristics

Nitrile butadiene rubber; blue; powder-free; non-sterile. Dimensions and physical properties meet ASTM D6319-10. Permeation resistance tested per ASTM D6978-05. Biocompatibility per ISO 10993-10 and ISO 10993-11. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical device worn on examiner's hands or fingers to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs per ASTM D6978-05.

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

• Polymer Patient Examination Glove (K200581)

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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

January 19, 2022

Showa Best Glove, Inc. Jeffrey Richardson Director of Operations 579 Edison Street Menlo, Georgia 30731

Re: K211003

Trade/Device Name: SHOWA® Blue Nitrile Powder Free Medical Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: December 8, 2021 Received: December 9, 2021

Dear Jeffrey Richardson:

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.

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

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

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD 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) K211003

Device Name

SHOWA®Blue Nitrile Powder Free Medical Examination Glove

#### Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

Chemotherapy Drugs and Concentration Minimum breakthrough detection time (Min) ug/cm2/min Chemotherapy Drug and concentration Minimum Breakthrough, detection time in minutes, minutes 1) Blenoxane (15.0 mg/ml) 15,000 ppm >240 minutes 2) Busulfan (6.0 mg/ml) 6,000 ppm >240 minutes 3) Carboplatin (10.0 mg/ml) 10,000 ppm >240 minutes 4) Carmustine (3.3 mg/ml) 3,300 ppm 73.7 minutes 5) Cisplatin (1.0 mg/ml) 1,000 ppm >240 minutes 6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm >240 minutes 7) Cytarabine (100.0 mg/ml) 100,000 ppm >240 minutes 8) Dacarbazine (10.0 mg/ml) 10,000 ppm >240 minutes 9) Daunorubicin HCl (5.0 mg/ml) 5,000 ppm >240 minutes 10) Docetaxel (10.0 mg/ml) 10,000 ppm >240 minutes l 1) Doxorubicin HCl (2.0 mg/ml) 2,000 ppm >240 minutes 12) Epirubicin HCl (2.0 mg/ml) 2,000 ppm >240 minutes 13) Etoposide (20.0 mg/ml) 20,000 ppm >240 minutes 14) Fludarabine (25.0 mg/ml) 25.000 ppm >240 minutes 15) Fluorouracil (50.0 mg/ml 50,000 ppm >240 minutes 16) Gemcitabine (38.0 mg/ml) 38,000 ppm >240 minutes 17) Idarubicin HCl (1.0 mg/ml) 1,000 ppm >240 minutes 18) Ifosfamide (50.0 mg/ml) 50,000 ppm >240 minutes 19) Irinotecan (20.0 mg/ml) 20,000 ppm >240 minutes 20) Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm >240 minutes 21) Melphalan (5.0 mg/ml) 5,000 ppm >240 minutes 22) Methotrexate (25.0 mg/ml) 25,000 ppm >240 minutes 23) Mitomycin C (0.5 mg/ml) 500 ppm >240 minutes 24) Mitoxantrone (2.0 mg/ml) 2,000 ppm >240 minutes 25) Paclitaxel (6.0 mg/ml) 6,000 ppm >240 minutes 26) Rituximab (10.0 mg/ml) 10,000 ppm >240 minutes 27) ThioTepa (10.0 mg/ml)10,000 ppm 25.4 minutes 28) Trisenox (1.0 mg/ml) 1,000 ppm >240 minutes 29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm >240 minutes The maximum testing time is 240 minutes. Warning: Do not use with Carmustine or ThioTepa.

. ..

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

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."

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

# 510(k) Summary K211003 DATE OF PREPARATION: January 14, 2022

#### I. SUBMITTER

Showa Best Glove, Inc. 579 Edison Street Menlo. GA 30731 Tel: [phone] Fax: [phone]

#### II. OFFICIAL CORRESPONDENCE/CONTACT PERSON

Jeffrey Richardson Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: [phone] Fax: [phone] Email: [e-mail]

#### III. 510(K) PREPARER

Brian Moseley Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: [phone] Fax: [phone] Email: [e-mail]

#### IV.PROPOSED DEVICE

Trade Name/Proprietary Name: SHOWA® Blue Nitrile Powder Free Medical Examination Glove Common or Usual Name: Nitrile Patient Examination Glove Classification Name: Patient Examination Glove Regulation: 21 CFR 880.6250 Device Classification: Class: I Product Code: LZA, LZC

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

### V. PREDICATE DEVICE

Device Classification Name: Polymer Patient Examination Glove 510(k) Number: K200581 Product Code: LZA, LZC Applicant: Hartelega NGC SDN.BHD. Kawasan Perindustrian Tanjung Sepang, MY 43900

#### VI.DEVICE DESCRIPTION

The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a Nitrile Butadiene Rubber, blue in color, powder free and non-sterile (per 21 CFR Part 880.6250, class I). The device meets all the specifications in ASTM D6319-10. Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.

The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is designed to be used for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between the patient and the examiner (product code LZA). In addition, these gloves were tested for use with chemotherapy drugs (product code LZC) in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

#### VII. INDICATIONS FOR USE

A patient examination qlove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

| Chemotherapy Drug and concentration | Minimum Breakthrough, detection<br>time in minutes, minutes |
|---------------------------------------------|-------------------------------------------------------------|
| 1) Blenoxane (15.0 mg/ml) 15,000 ppm | >240 |
| 2) Busulfan (6.0 mg/ml) 6,000 ppm | >240 |
| 3) Carboplatin (10.0 mg/ml) 10,000 ppm | >240 |
| 4) Carmustine (3.3 mg/ml) 3,300 ppm | 73.7 |
| 5) Cisplatin (1.0 mg/ml) 1,000 ppm | >240 |
| 6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm | >240 |
| 7) Cytarabine (100.0 mg/ml) 100,000 ppm | >240 |
| 8) Dacarbazine (10.0 mg/ml) 10,000 ppm | >240 |
| 9) Daunorubicin HCI (5.0 mg/ml) 5,000 ppm | >240 |
| 10) Docetaxel (10.0 mg/ml) 10,000 ppm | >240 |
| 11) Doxorubicin HCI (2.0 mg/ml) 2,000 ppm | >240 |
| 12) Epirubicin HCI (2.0 mg/ml) 2,000 ppm | >240 |
| 13) Etoposide (20.0 mg/ml) 20,000 ppm | >240 |
| 14) Fludarabine (25.0 mg/ml) 25,000 ppm | >240 |

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

| 15) Fluorouracil (50.0 mg/ml 50,000 ppm | >240 |
|------------------------------------------|------|
| 16) Gemcitabine (38.0 mg/ml) 38,000 ppm | >240 |
| 17) Idarubicin HCl (1.0 mg/ml) 1,000 ppm | >240 |
| 18) Ifosfamide (50.0 mg/ml) 50,000 ppm | >240 |

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

| 19) Irinotecan (20.0 mg/ml) 20,000 ppm | >240 |
|-----------------------------------------------|------|
| 20) Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm | >240 |
| 21) Melphalan (5.0 mg/ml) 5,000 ppm | >240 |
| 22) Methotrexate (25.0 mg/ml) 25,000 ppm | >240 |
| 23) Mitomycin C (0.5 mg/ml) 500 ppm | >240 |
| 24) Mitoxantrone (2.0 mg/ml) 2,000 ppm | >240 |
| 25) Paclitaxel (6.0 mg/ml) 6,000 ppm | >240 |
| 26) Rituximab (10.0 mg/ml) 10,000 ppm | >240 |
| 27) ThioTepa (10.0 mg/ml)10,000 ppm | 25.4 |
| 28) Trisenox (1.0 mg/ml) 1,000 ppm | >240 |
| 29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm | >240 |

The maximum testing time is 240 minutes. Warning: Do not use with Carmustine or ThioTepa.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VIII.

| | Proposed Device | | Predicate Device | | Comparison |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------|
| Characteristics | SHOWA® Blue Nitrile Powder Free Medical<br>Examination Glove K211003 | | Polymer Patient Examination Glove<br>510(k) Number K200581 | | |
| Device<br>Description/<br>Regulation<br>Number | Patient examination glove 21 CFR § 880.6250 | | Patient examination glove 21 CFR §<br>880.6250 | | Same |
| Product Code | LZA, LZC | | LZA, LZC, QDO | | Similar |
| Indications for<br>Use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands or fingers to<br>prevent contamination<br>between patient and<br>examiner.<br>These gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 Standard<br>Practice for Assessment<br>of Medical Glove to<br>Permeation by<br>chemotherapy drugs.<br>Chemotherapy Drugs and<br>Concentration<br>1) Blenoxane (15.0 mg/ml)<br>15,000 ppm<br>2) Busulfan (6.0 mg/ml) 6,000<br>ppm<br>3) Carboplatin (10.0 mg/ml)<br>10,000 ppm<br>4) Carmustine (3.3 mg/ml)<br>3,300 ppm | Minimum<br>Breakthrough,<br>detection time in<br>minutes, minutes<br>>240 minutes<br>>240 minutes<br>>240 minutes<br>73.7 minutes | Biodegradable Nitrite Powder Free<br>Examination Gloves Tested for Use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate (Blue) is a non-sterile disposable<br>device intended for medical purpose that<br>is worn on the examiner's hand to prevent<br>contamination between patient and<br>examiner. It is also tested to be used<br>against Chemotherapy Drugs and<br>Fentanyl Citrate, These gloves were<br>tested for use with chemotherapy drugs<br>and Fentanyl Citrate as per ASTM<br>D6978-05 (Reapproved 2013) Standard<br>Practice for Assessment of Medical<br>Gloves to Permeation by Chemotherapy<br>Drugs.<br>Chemotherapy Drug and<br>Concentration<br>Carmustine (3.3 mg/ml)<br>Cisplatin (1.0 mg/ml)<br>Cyclophosphamide (20.0<br>mg/ml)<br>Dacarbazine (10.0 mg/ml)<br>Doxorubicin Hydrochloride<br>(2.0 mg/ml)<br>Etoposide (20.0 mg/ml)<br>Fluorouracil (50.0 mg/ml)<br>Methotrexate (25.0 mg/ml) | Minimum<br>Breakthrough<br>Detection<br>Time in<br>Minutes<br>21.4<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240 | Similar |

{8}------------------------------------------------

| 5) Cisplatin (1.0 mg/ml) 1,000 ppm | >240 minutes | Paclitaxel (6.0 mg/ml) | >240 |
|---------------------------------------------|--------------|---------------------------------|------|
| 6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm | >240 minutes | Thiotepa (10.0 mg/ml) | 67.2 |
| 7) Cytarabine (100.0 mg/ml) | >240 minutes | Vincristine Sulfate (1.0 mg/ml) | >240 |
| | | Azacytidine (25.0 mg/ml) | >240 |

{9}------------------------------------------------

| | 100,000 ppm | | | | | | | | |
|-----------------------------------|----------------------------------------------------------------------------------------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------|--|------|--|--|
| | 8) Dacarbazine (10.0 mg/ml)<br>10,000 ppm | >240 minutes | Carboplatin (10.0 mg/ml) | >240 | | | | | |
| | 9) Daunorubicin HCI (5.0 mg/ml) 5,000 ppm | >240 minutes | Docetaxel (10 mg/ml) | >240 | | | | | |
| | 10) Docetaxel (10.0 mg/ml) 10,000 ppm | >240 minutes | Epirubicin (2.0 mg/ml) | >240 | | | | | |
| | 11) Doxorubicin HCI (2.0 mg/ml) 2,000 ppm | >240 minutes | Gemcitabine (38 mg/ml) | >240 | | | | | |
| | 12) Epirubicin HCI (2.0 mg/ml) 2,000 ppm | >240 minutes | Ifosfamide (50 mg/ml) | >240 | | | | | |
| | 13) Etoposide (20.0 mg/ml) 20,000 ppm | >240 minutes | Irinotecan (20 mg/ml) | >240 | | | | | |
| | 14) Fludarabine (25.0 mg/ml) 25,000 ppm | >240 minutes | Mitoxantrone (2.0 mg/ml) | >240 | | | | | |
| | 15) Fluorouracil (50.0 mg/ml 50,000 ppm | >240 minutes | Oncovin (1.0 mg/ml) | >240 | | | | | |
| | 16) Gemcitabine (38.0 mg/ml) 38,000 ppm | >240 minutes | Oxaliplatin (5 mg/ml) | >240 | | | | | |
| | 17) Idarubicin HCI (1.0 mg/ml) 1,000 ppm | >240 minutes | Vinorelbine () 0 mg/ml) | >240 | | | | | |
| | 18) Ifosfamide (50.0 mg/ml) 50,000 ppm | >240 minutes | Please note that Carmustine and Thiotepa have extremely low penetration times of 21.4 minutes and 67.2 minutes respectively.<br>Warning: Do not use with Carmustine | | | | | | |
| | 19) Irinotecan (20.0 mg/ml) 20,000 ppm | >240 minutes | | | | | | | |
| | 20) Mechlorethamine HCI (1.0 mg/ml) 1,000 ppm | >240 minutes | | | | | | | |
| | 21) Melphalan (5.0 mg/ml) 5,000 ppm | >240 minutes | | | | | | | |
| | 22) Methotrexate (25.0 mg/ml) 25,000 ppm | >240 minutes | | | | | | | |
| | 23) Mitomycin C (0.5 mg/ml) 500 ppm | >240 minutes | Fentanyl Citrate and<br>Concentration | Minimum<br>Breakthrough<br>Detection Time<br>in Minutes | | | | | |
| | 24) Mitoxantrone (2.0 mg/ml) 2,000 ppm | >240 minutes | | | | | | | |
| | 25) Paclitaxel (6.0 mg/ml) 6,000 ppm | >240 minutes | | | | | | | |
| | 26) Rituximab (10.0 mg/ml) 10,000 ppm | >240 minutes | Fentanyl Citrate Injection<br>(100 mcg/2ml) | >240 | | | | | |
| | 27) ThioTepa (10.0 mg/ml)10,000 ppm | 25.4 minutes | | | | | | | |
| | 28) Trisenox (1.0 mg/ml) 1,000 ppm | >240 minutes | | | | | | | |
| | 29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm | >240 minutes | | | | | | | |
| | The maximum testing time is 240 minutes.<br>Warning: Do not use with Carmustine or ThioTepa. | | | | | | | | |
| Material Use | Nitrile | | Nitrile | | Same | | | | |
| Color | Blue | | Blue | | Same | | | | |
| Sterility | Non-Sterile | | Non-Sterile | | Same | | | | |
| Dimensions | Meets ASTM D6319-10 | | Meets ASTM D6319-10 | | Same | | | | |
| Physical<br>Properties | Meets ASTM D6319-10 | | Meets ASTM D6319-10 | | Same | | | | |
| Freedom from<br>Holes<br>(D 5151) | AQL 2.5 Inspection Meets ASTM D5151-06 | | AQL 2.5 Inspection Meets ASTM D5151-06 | | Same | | | | |
| Residual Powder<br>(D 6124) | Meets ASTM D6124-06 | | Meets ASTM D6124-06 | | Same | | | | |
| Biocompatibility | Biocompatibility<br>test – Primary<br>Skin Irritation Test<br>(ISO 10993-10) | | Under the conditions of the study, not a<br>primary skin irritant. | | Under the conditions of the study, not a<br>primary skin irritant. | | Same | | |

{10}------------------------------------------------

| Biocompatibility<br>test – Dermal<br>Sensitization<br>Assay (ISO<br>10993-10) | Under conditions of the study, not a contact<br>sensitizer | Under conditions of the study, not a<br>contact sensitizer | Same |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|------|
| Biocompatibility<br>test – Acute | Under conditions of the ISO Acute Systemic<br>Injection test, not toxic | Under conditions of the ISO Acute<br>Systemic Injection test, not toxic | Same |

{11}------------------------------------------------

| systemic toxicity<br>Study (ISO<br>10993-11) | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Resistance<br>against<br>Chemotherapy<br>Drugs Standards<br>Practice for<br>Assessment of<br>resistance of<br>Medical Glove to<br>Permeation by<br>Chemotherapy<br>drugs<br>ASTM D6978-5<br>(2013) | Breakthrough greater than 240 min.<br>• Blenoxane (15.0 mg/ml)<br>• Busulfan (6.0 mg/ml)<br>• Carboplatin (10.0 mg/ml)<br>• Cisplatin (1.0 mg/ml)<br>• Cyclophosphamide (20.0 mg/ml)<br>• Cytarabine (100.0 mg/ml)<br>• Dacarbazine (10.0 mg/ml)<br>• Daunorubicin HCI (5.0 mg/ml)<br>• Docetaxel (10.0 mg/ml)<br>• Doxorubicin HCI (2.0 mg/ml)<br>• Epirubicin HCI (2.0 mg/ml)<br>• Etoposide (20.0 mg/ml)<br>• Fludarabine (25.0 mg/ml)<br>• Fluorouracil (50.0 mg/ml)<br>• Gemcitabine (38.0 mg/ml)<br>• Idarubicin HCI (1.0 mg/ml)<br>• Ifosfamide (50.0 mg/ml)<br>• Irinotecan (20.0 mg/ml)<br>• Mechlorethamine HCI (1.0 mg/ml)<br>• Melphalan (5.0 mg/ml)<br>• Methotrexate (25.0 mg/ml)<br>• Mitomycin C (0.5 mg/ml)<br>• Mitoxantrone (2.0 mg/ml)<br>• Paclitaxel (6.0 mg/ml)<br>• Rituximab (10.0 mg/ml)<br>• Trisenox (1.0 mg/ml)<br>• Vincristine Sulfate (1.0 mg/ml)<br><br>Breakthrough at 73.7 min.<br>Carmustine (3.3 mg/ml)<br><br>Breakthrough at 25.4 min.<br>ThioTepa (10.0 mg/ml) | Breakthrough greater than 240 min.<br>• Cisplatin (1.0 mg/ml)<br>• Cyclophosphamide (20.0 mg/ml)<br>• Dacarbazine (10.0 mg/ml)<br>• Doxorubicin Hydrochloride (2.0<br>mg/ml)<br>• Etoposide (20.0 mg/ml)<br>• Fluorouracil (50.0 mg/ml)<br>• Methotrexate (25.0 mg/ml)<br>• Mitomycin C (0.5 mg/ml)<br>• Paclitaxel (6.0 mg/ml)<br>• Vincristine Sulfate (1.0 mg/ml)<br>• Azacytidine (25.0 mg/m1)<br>• Carboplatin (10.0 mg/ml)<br>• Docetaxel (10 mg/ml)<br>• Epirubicin (2.0 mg/ml)<br>• Gemcitabine (38 mg/ml)<br>• Ifosfamide (50 mg/ml)<br>• Irinotecan (20 mg/ml)<br>• Mitoxantrone (2.0 mg/ml)<br>• Oncovin (1.0 mg/ml)<br>• Oxaliplatin (5 mg/ml)<br>• Vinorelbine (10 mg/ml)<br>• Fentanyl Citrate (100 mcg/2ml)<br><br>Breakthrough at 21.4 min.<br>Carmustine (3.3 mg/ml)<br><br>Breakthrough at 67.2 min.<br>Thiotepa (10.0 mg/ml) | Similar |

# IX. SUMMARY OF NONCLINICAL TESTING

| Test Method | Purpose | Acceptance Criteria | Results |
|---------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ASTM D6319-10 | Demonstrate<br>accurate sizing | Dimensions<br>Overall Length (mm) =<br>220 mm (sizes XS – S) and<br>230 mm (sizes M - XL)<br>Width (± 10 mm)<br>Size XS = 70 mm Size S = 80 mm Size M = 95 mm<br>Size L = 110 mm Size XL = 120 mm<br>Thickness at Palm (mm) = 0.05 min.<br>Thickness at Finger Tip (mm) = 0.05 min. | Pass |

{12}------------------------------------------------

| ASTM D6319-10 | Demonstrate<br>tensile<br>conforming<br>properties | Before Aging (D 412):<br>Tensile Strength (MPa) = 14 min<br>Ultimate Elongation (%) = 500 min. | Pass |
|---------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------|
| | | After Aging (D 573) (70°C ± 2°C for 166 hrs ± 2 hrs.):<br>Tensile Strength (MPa) = 14 min<br>Ultimate Elongation (%) = 400 min | |

{13}------------------------------------------------

| ASTM D6319-10 | Demonstrate<br>glove integrity | Freedom from Holes (D 5151)<br>AQL 2.5 Inspection Level G-1 | Pass |
|--------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------|------|
| ASTM D6319-10 | Demonstrate<br>biocompatibility:<br>Residual powder | Residual Powder (D 6124)<br>≤ 2.0 mg/pc | Pass |
| Primary Skin<br>Irritation Test<br>ISO 10993-10 | Demonstrate<br>biocompatibility:<br>Skin irritation | Under the conditions of the study, Not a primary skin<br>irritant. | Pass |
| Dermal<br>Sensitization<br>Assay<br>ISO 10993-10 | Demonstrate<br>biocompatibility:<br>Skin sensitivity | Under the conditions of the study, Not a contact<br>sensitizer. | Pass |
| Acute Systemic<br>toxicity Study<br>ISO 10993-11 | Demonstrate<br>biocompatibility:<br>acute systemic<br>toxicity | Under conditions of the ISO Acute Systemic Injection<br>test, not toxic | Pass |
| Open box testing<br>AAMI 11737-1 | Demonstrate<br>acceptable open<br>box bioburden | Acceptable bioburden levels after 30 days open box | Pass |

# X. SUMMARY OF CLINICAL TESTING

No clinical testing was performed.

### XI. CONCLUSION

The conclusions drawn from the non-clinical testing demonstrates that the SHOWA® Blue Nitrile Powder Free Medical Examination Glove is as safe, as effective, and performs as well or better than the legally marketed device (K200581).