Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)

K162095 · Yty Industry (Manjung) Sdn Bhd · LZA · Nov 2, 2016 · General Hospital

Device Facts

• Record ID: K162095
• Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Nov 2, 2016
• Decision: SESE
• Submission Type: Traditional
• 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 finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs.

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves; intended for medical use to prevent cross-contamination between patient and examiner. Device provides barrier protection; tested for resistance to permeation by specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings by healthcare providers. Output is physical barrier protection; healthcare provider uses glove during patient examination or chemotherapy drug handling. Benefits include reduced risk of contamination and exposure to hazardous drugs. Warning: Not for use with Carmustine or ThioTEPA due to low permeation times.

Clinical Evidence

Bench testing only. Performance data includes barrier integrity (ASTM D5151-06), physical properties (ASTM D6319-10), powder content (ASTM D6124-06), and biocompatibility (ISO 10993-10). Chemotherapy drug permeation testing performed per ASTM D6978-05.

Technological Characteristics

Material: Nitrile latex compound. Form factor: Disposable, powder-free, finger-textured, non-sterile gloves. Dimensions: Min 240mm length, thickness 0.05-0.14mm. Standards: ASTM D6319-10, ASTM D6978-05, ASTM D6124-06, ISO 10993-10. Connectivity: None. Sterilization: Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs.

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

• Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs (K141982)
• Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) (K151997)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three overlapping profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

YTY Industry (Manjung) Sdn. Bhd., Punitha Samy Deputy Manager-DC/RA Lot 1422-1424 Batu 10 Lekir Sitiawan, Perak 32020 MY

Re: K162095

Trade/Device Name: Non-sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Original Blue, Cobalt Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 19, 2016 Received: September 23, 2016

Dear Punitha Samy:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K162095

### Device Name

Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Original Blue

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 finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|--------------------------------------------|-------------------------------------|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 1.84 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 0.76 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 1.84 minutes ThioTEPA (10.0 mg/ml): 0.76 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.

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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."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K162095

### Device Name

Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue

#### 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 finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|--------------------------------------------|-------------------------------------|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 1.82 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 0.93 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 1.82 minutes ThioTEPA (10.0 mg/ml): 0.93 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.

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

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 Druq 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."

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## K162095

## 510 (K) SUMMARY SHEETS

| 1.0 | | | <b>510 (K) SUMMARY</b> |
|-----|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 2.0 | <b>Submitter</b> | YTY INDUSTRY (MANJUNG) SDN. BHD.,<br>Lot 1422-1424, Batu 10 Lekir<br>32020 Sitiawan, Perak<br>Malaysia | |
| | <b>Tel</b> | 605-6908533 | |
| | <b>Fax</b> | 605-6908533 | |
| | <b>Name of Contact Person</b> | Punitha Samy (Ms)<br>E-mail: [e-mail] | |
| | <b>Date Summary Prepared</b> | November 2, 2016 | |
| 3.0 | <b>Name of Device</b> | | |
| | <b>Trade Name:</b> | Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves,<br>Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | |
| | <b>Common Name:</b> | Nitrile Examination Gloves | |
| | <b>Classification Name:</b> | Patient Examination Gloves, Powder Free | |
| | <b>Device Classification:</b> | I | |
| | | Regulation No. & Classification Name: Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC)<br>Patient Examination Gloves (21 CFR 880.6250 product code LZA) | |

Panel:

General Hospital

#### 4.0 Identification of The Legally Marketed Devices that equivalency is claimed:

| Device Name | Dermagrip Powder Free<br>Blue Nitrile Patient<br>Examination Gloves, Non-<br>Sterile, Tested for use with<br>Chemotherapy Drugs | Nitrile Powder Free<br>Examination Gloves Tested<br>for Use with<br>Chemotherapy Drugs -<br>Violet Blue (VBLU) |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Predicate 510(K)<br>number: | K141982 | K151997 |
| Device Classification: | 1 | 1 |
| Product Code: | LZC | LZC |

## Sec 1 Sum Page 1 of 8

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#### 5.0 Description of The Device

Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

#### 6.0 The Intended Use of Glove

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

| Characteristic | Concentration | K162095<br>Original Blue | K162095<br>Cobalt Blue |
|-------------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Average Breakthrough Detection Time (minutes) | |
| Carboplatin | 10mg/ml | > 240 | > 240 |
| *Carmustine | 3.3mg/ml | 1.84 | 1.82 |
| Cisplatin (BCNU) | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide<br>(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| Doxorubicin<br>Hydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 | > 240 |
| Methotrexate | 25mg/ml | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 0.76 | 0.93 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | | *WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 1.84 minutes and ThioTepa: 0.76 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA | * WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 1.82 minutes and ThioTepa: 0.93 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA |

Sec 1 Sum Page 2 of 8

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#### 7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion

There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) have the below technological characteristic compared to ASTM or Equivalent standards.

This glove is compliant with the ASTM standards and similar to the predicate device in the market, which has a glove thickness less than 0.10mm and length less than 270mm. The chemotherapy claim is similar to Predicate.

| Table 1 – Predicate 1 | | |
|-----------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Standards | Device Performance |
| | | Predicate K162095 – Original Blue |
| 510(K) Number | | K141982 K162095 |
| Dimension | ASTM D6319-10 | Min 240mm Min 240mm |
| Physical Properties | ASTM D6319-10 | Meets Meets |
| Thickness | ASTM D6319-10 | Finger 0.07 – 0.10mm 0.09 – 0.14mm<br>Palm 0.07 – 0.09mm 0.07 - 0.10mm<br>Cuff 0.06 – 0.08mm 0.06 – 0.09mm |
| Powder-free | ASTM D6124-06<br>(<2mg/glove) | Meets Meets |
| Bio-compatibility | Primary skin<br>irritation<br>ISO 10993-10 (2010)<br>Dermal Sensitization<br>ISO 10993-10 (2010) | Not a primary skin irritant<br>under the conditions of<br>the study Under the condition of<br>the study the device is<br>non-irritant<br>Not a contact sensitizer<br>under the conditions of<br>the study Under the condition of<br>the study the device is<br>non-sensitizer |

| | Table 1 - Predicate 1 | |
|--|-----------------------|--|
|--|-----------------------|--|

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| Characteristic | Tested according<br>to ASTM D6978-<br>05 | Device Performance | |
|-------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Concentration | Predicate-K141982 | K162095– Original Blue |
| | | Average Breakthrough Detection Time (minutes) | |
| Carboplatin | 10mg/ml | - | > 240 |
| *Carmustine | 3.3mg/ml | 15 | 1.84 |
| Cisplatin | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide<br>(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| Doxorubicin<br>Hydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide (Ifex) | 50.0mg/ml | > 240 | > 240 |
| Methotrexate | 25mg/ml | - | > 240 |
| Mitomycin C | 0.5mg/ml | - | > 240 |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 2.0 | 0.76 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | | *WARNING: Please note that<br>the following drugs have<br>extremely low permeation<br>times: Carmustine (BCNU) :<br>15 minutes and Thiotepa : 2<br>minutes | *WARNING: Please note that<br>the following drugs have<br>extremely low permeation<br>times: Carmustine: 1.84<br>minutes and ThioTepa: 0.76<br>minutes. NOT TO BE USED<br>WITH CARMUSTINE OR<br>THIOTEPA |

## Table 2 – Predicate 1

# Table 3 – Predicate 2

| Characteristic | Standards | Device Performance | |
|---------------------|------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|
| | | Predicate | K162095 – Cobalt Blue |
| 510(K) Number | | K151997 | K162095 |
| Dimension | ASTM D6319-10 | Min 240mm | Min 240mm |
| Physical Properties | ASTM D6319-10 | Meets | Meets |
| Thickness | Finger | 0.10min | 0.10min |
| | Palm | 0.07 – 0.09mm | 0.07 – 0.09mm |
| | Cuff | | 0.05 - 0.08mm |
| Powder-free | ASTM D6124-06<br>(< 2mg/glove) | Meets | Meets |
| Bio-compatibility | Primary skin<br>irritation<br>ISO 10993-10<br>(2010) | Not a primary skin irritant under<br>the conditions of the study | Under the condition of the<br>study the device is non-<br>irritant |
| | Dermal<br>Sensitization<br>ISO 10993-10<br>(2010) | Not a contact sensitizer under<br>the conditions of the study | Under the condition of the<br>study the device is non-<br>sensitizer |

Sec 1 Sum Page 4 of 8

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| Table 4 - Predicate 2 | | | |
|-------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Tested according to<br>ASTM D6978-05 | Device Performance | |
| | | Predicate - K151997 | K162095 – Cobalt Blue |
| | | Average Breakthrough Detection Time (minutes) | |
| | Concentration | Predicate | Current |
| Carboplatin | 10mg/ml | - | > 240 |
| *Carmustine | 3.3mg/ml | 10.2 | 1.82 |
| Cisplatin | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide<br>(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| Doxorubicin<br>Hydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide (Ifex) | 50.0mg/ml | - | > 240 |
| Methotrexate | 25mg/ml | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 |
| Mitoxantrone | 2 mg/ml | - | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 30.2 | 0.93 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | | * Please note that<br>Carmustine and Thiotepa<br>have extremely low<br>permeation times of 10.2<br>minutes and 30.2<br>minutes | * WARNING: Please note that<br>the following drugs have<br>extremely low permeation<br>times: Carmustine: 1.82<br>minutes and ThioTepa: 0.93<br>minutes. NOT TO BE USED<br>WITH CARMUSTINE OR<br>THIOTEPA |

Table 4 – Predicate 2

Sec 1 SUM Page 5 of 8

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| Table 5 Device Performance | | | | | |
|-----------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Predicate<br>K141982 | K162095<br>Original Blue | Predicate<br>K151997 | K162095<br>Cobalt Blue | Medical Glove<br>Manual (1661) and<br>Standards |
| Water tightness<br>(1000ml) | Passes | Passes | Passes | Passes | ASTM D5151-06 |
| Color | Blue | Original Blue | Violet Blue | Cobalt Blue | ASTM D6319-10<br>(Reapproved 2015) |
| Material | Nitrile | Nitrile | Nitrile | Nitrile | Labeling |
| Size | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Labeling |
| Texture | Finger Textured | Finger Textured | Finger<br>Textured | Finger<br>Textured | |
| Single Use | Single Use | Single Use | Single Use | Single Use | Labeling |
| Bio-compatibility | Passes | Passes | Passes | Passes | Primary Skin Irritation |
| | Not primary skin<br>irritant under the<br>conditions of the study. | Under the condition of the<br>study the device is non-irritant | Under the condition of<br>the study the device is<br>non-irritant | Under the condition of the<br>study the device is non-<br>irritant | ISO 10993-10: 2010(E)<br>Test for Irritation and<br>Skin Sensitization &<br>Consumer Product<br>Safety Commission II,<br>Part 1500 |
| | Passes<br>Not a contact sensitizer<br>under the conditions of<br>the study. | Passes<br>Under the condition of the<br>study the device in non-<br>sensitizer | Passes<br>Under the condition of<br>the study the device in<br>non-sensitizer | Passes<br>Under the condition of the<br>study the device in non-<br>sensitizer | Dermal Sensitization -<br>ISO 10993-10(E) &<br>Consumer Product<br>Safety Commission,<br>Title 16, Chapter II,<br>Part 1500.3 (c) (4) |

Tahle 5

Sec 1 SUM Page 6 of 8

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| Indications for Use | A patient<br>Examination glove is a<br>medical device intended<br>for medical purposes<br>that is worn on the<br>examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | A patient examination gloves is a<br>disposable device intended for<br>medical purpose that is worn on the<br>examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. This glove is<br>also tested for use against<br>Chemotherapy<br>Drugs. The Chemotherapy Drugs<br>and its permeation time is listed as<br>below. | Is nonsterile<br>disposable device<br>intended for medical<br>purpose that is worn on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. It is also<br>tested to be used against<br>Chemotherapy Drugs. | A patient examination gloves is a<br>disposable device intended for<br>medical purpose that is worn on the<br>examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. This<br>glove is also tested for use against<br>Chemotherapy<br>Drugs. The Chemotherapy Drugs<br>and its permeation time is listed as<br>below. | This gloves meet all<br>current specifications<br>listed under ASTM<br>specifications D6319-10 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | *Carmustine3.3mg/ml15<br>Cisplatin 1.0mg/ml ><br>240<br>Cyclophosphamide<br>Cytoxan) 20.0mg/ml > | Tested Chemotherapy<br>Drug And Concentration | Carmustine (3.3 mg/ml)<br>10.2 minutes<br>Cisplatin (1.0 mg/ml) >240<br>minutes<br>Cyclophosphamide (20<br>mg/ml) >240 minutes<br>Dacarbazine (10.0 mglml)<br>>240 minutes<br>Doxorubicin<br>Hydrochloride (2.0 mg/ml)<br>>240 minutes<br>Etoposide (20.0 mg/ml)<br>>240 minutes | Tested Chemotherapy<br>Drug And Concentration | |
| | 240<br>Dacarbazine (DTIC)<br>10.0mg/ml> 240<br>Doxorubicin<br>Hydrochloride 2.0mg/ml><br>240<br>Etoposide (Toposar)<br>20.0mg/ml> 240 | Carboplatin, 10 mg/ml<br>Carmustine (3.3 mg/ml)<br>Cisplatin (BCNU), 1.0<br>mg/ml<br>Cyclophosphamide<br>(Cytoxan), 20.0 mg/ml<br>Dacarbazine (DTIC), 10.0<br>mg/ml | Fluorouracil (50.0 mg/ml)<br>Methotrexate (25 mg/ml) | Carboplatin, 10mg/ml<br>Carmustine (3.3 mg/ml)<br>Cisplatin (BCNU), 1.0<br>mg/ml<br>Cyclophosphamide<br>(Cytoxan), 20.0 mg/ml<br>Dacarbazine (DTIC), 10.0<br>mg/ml | |
| | Fluorouracil 50.0mg/ml><br>240<br>Ifosfamide (Ifex)<br>50.0mg/ml> 240 | Doxorubicin<br>Hydrochloride, 2.0 mg/ml<br>Etoposide (Toposar), 20.0<br>mg/ml | | Doxorubicin<br>Hydrochloride, 2.0 mg/ml<br>Etoposide (Toposar), 20.0<br>mg/ml | |
| | Mitoxantrone 2 mg/ml><br>240<br>Paclitaxel (Taxol)<br>6.0mg/ml> 240<br>Thiotepa 10.0mg/ml 2.0 | Fluorouracil, 50.0 mg/ml<br>Ifosfamide , 50.0 mg/ml<br>Methotrexate, 25 mg/ml<br>Mitomycin C, 0.5 mg/ml<br>Mitoxantrone, 2 mg/ml | Mitomycin C (0.5 mg/ml)<br>>240 minutes<br>Paclitaxel (6.0 mg/ml)<br>>240 minutes<br>Thiotepa (10.0 mg/ml)<br>30.2 minutes<br>Vincristine Sulfate (1.0<br>mg/ml) >240 minutes<br>Please note that<br>Carmustine and Thiotepa<br>have extremely low | Fluorouracil, 50.0 mg/ml<br>Ifosfamide , 50.0 mg/ml<br>Methotrexate, 25 mg/ml<br>Mitomycin C, 0.5 mg/ml<br>Mitoxantrone, 2 mg/ml | |
| | Vincristine Sulfate<br>1.0mg/ml> 240<br>Warning Statement | Paclitaxel (Taxol), 6.0<br>mg/ml<br>ThioTEPA (10.0 mg/ml)<br>Vincristine Sulfate, 1.0 | | Paclitaxel (Taxol), 6.0<br>mg/ml<br>ThioTEPA (10.0 mg/ml) | |
| | *WARNING: Please note<br>that the following drugs<br>have extremely low | mg/ml<br>The following chemotherapy drugs and | | mg/ml<br>The following chemotherapy drugs and | |
| | permeation times:<br>Carmustine (BCNU) : 15<br>minutes and Thiotepa : 2<br>minutes | concentration have extremely low<br>permeation time.<br>Carmustine (3.3 mg/ml): 1.84 min<br>ThioTEPA (10.0 mg/ml): 0.76 min | | concentration have extremely low<br>permeation time.<br>Carmustine (3.3 mg/ml): 1.82 min<br>ThioTEPA (10.0 mg/ml): 0.93 min | |
| | | Average<br>Break<br>through<br>Detection<br>Time | | Average<br>Break<br>through<br>Detection<br>Time | |
| | | >240 min | | >240 min | |
| | | 1.84 min | | 1.82 min | |
| | | >240 min | | >240 min | |
| | | >240 min | | >240 min | |
| | | >240 min | | >240 min | |
| | | >240 min | | >240 min | |
| | | >240 min | | >240 min | |
| | | >240 min | | >240 min | |
| | | >240 min…