HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

K162381 · Healthy Glove Co., Ltd. · LZA · Jan 31, 2017 · General Hospital

Device Facts

• Record ID: K162381
• Device Name: HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
• Applicant: Healthy Glove Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder-free 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. In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Non-sterile, lavender blue, powder-free, ambidextrous nitrile synthetic rubber examination glove; intended for single use by healthcare professionals to prevent cross-contamination. Device provides a physical barrier; tested for permeation resistance against 32 specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; provides protection during handling of chemotherapy agents. Benefits include reduced risk of exposure to hazardous drugs and patient-examiner contamination.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ASTM D6319-10 (physical properties, dimensions, thickness), ASTM D5151-06 (watertightness), ASTM D6124-06 (residual powder), ISO 10993-10 (biocompatibility/irritation/sensitization), and ASTM D6978-05 (chemotherapy drug permeation).

Technological Characteristics

Material: Nitrile synthetic rubber. Form factor: Ambidextrous, powder-free, lavender blue, textured fingers. Dimensions: 270 mm minimum length, various palm widths. Thickness: 0.10 mm minimum (finger/palm). Standards: ASTM D6319-10, ASTM D6978-05. Biocompatibility: ISO 10993-10 compliant. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn by medical personnel to prevent cross-contamination between patient and examiner. Tested for resistance to permeation by 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

• PURPLE NITRILE-XTRA* Powder-Free Exam - 12' Length (K113423)

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 caduceus or a series of interconnected human profiles.

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

January 31, 2017

Healthy Glove Co., Ltd Teoh Shee Managing Director 119 Kanchanavanich Road, Tambol Patong Hatyai, Songkhla, Thailand 90230

Re: K162381

Trade/Device Name: HG PRO XP® Nitrile Powder Free Examination Gloves Tested For Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: November 28, 2016 Received: December 5, 2016

Dear Teoh Shee:

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K162381

Device Name

HG PRO® XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

A powder-free 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.

In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The gloves have been tested with the following drugs and the respective breakthrough detection times are listed belov.

| No. | Chemotherapy Drugs and Concentrations | Breakthrough |
|-----|---------------------------------------|---------------|
| 1. | Blenoxane (15 mg/ml) | > 240 minutes |
| 2. | Busulfan (6 mg/ml) | > 240 minutes |
| 3. | Carboplatin (10 mg/ml) | > 240 minutes |
| 4. | Carmustine (BCNU) (3.3 mg/ml)* | 30.4 minutes |
| 5. | Cisplatin (1.0 mg/ml) | > 240 minutes |
| 6. | Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| 7. | Cytarabine (100 mg/ml) | > 240 minutes |
| 8. | Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| 9. | Daunorubicin (5 mg/ml) | > 240 minutes |
| 10. | Docetaxel (10.0 mg/ml) | > 240 minutes |
| 11. | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| 12. | Ellence (2 mg/ml) | > 240 minutes |
| 13. | Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| 14. | Fludarabine (25 mg/ml) | > 240 minutes |
| 15. | Fluorouracil (50.0 mg/ml) | > 240 minutes |
| 16. | Ganciclovir (10 mg/ml) | > 240 minutes |
| 17. | Gemcitabine (Gemzar) (38 mg/ml) | > 240 minutes |
| 18. | Idarubicin (1 mg/ml) | > 240 minutes |
| 19. | Ifosfamide (50.0 mg/ml) | > 240 minutes |
| 20. | Irinotecan (20.0 mg/ml) | > 240 minutes |
| 21. | Mechlorethamine HCl (1.0 mg/ml) | > 240 minutes |
| 22. | Melphalan (5 mg/ml) | > 240 minutes |
| 23. | Methotrexate (25 mg/ml) | > 240 minutes |
| 24. | Mitoxantrone (2.0mg/ml) | > 240 minutes |
| 25. | Mitomycin C (0.5 mg/ml) | > 240 minutes |
| 26. | Oxaliplatin (5 mg/ml) | > 240 minutes |
| 27. | Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| 28. | Rituximab (10 mg/ml) | > 240 minutes |
| 29. | Thiotepa (10.0 mg/ml) | > 240 minutes |
| 30. | Trisenox (0.1 mg/ml) | > 240 minutes |
| 31. | Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
| 32. | Vinorelbine (10 mg/ml) | > 240 minutes |

Detection Time in Minutes

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* Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) at 30.4 minutes

Type of Use (Select one or both, as applicable)

J Prescription Use (Part 21 CFR 801 Subpart D)

Z Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left and a white hexagon on the right. Inside the pink circle are four horizontal white lines. Inside the white hexagon are the letters "H" and "G" in blue.

## HEALTHY GLOVE CO., LTD. 119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: [phone] Fax: [phone]

# 510(k) SUMMARY Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

### 1.0 Submitter:

| Applicant: | Healthy Glove Co., Ltd<br>119 Kanchanavanich Road, Tambol Patong<br>Hat Yai, Songkhla 90230<br>Thailand |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Name of Contact Person: | Choh-Shee Teoh (Mr) |
| Preparation date: | November 24, 2016 |

### 2.0 Name of Subject Device:

| Trade/Proprietary Name(s): | HG PRO® XP Nitrile Powder Free Examination Gloves Tested for Use<br>with Chemotherapy Drugs |
|----------------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Nitrile Powder Free Examination Gloves Tested for Use with<br>Chemotherapy Drugs |
| Classification Name: | Patient Examination Gloves (21 CFR 880.6250) |
| Device Class: | I |
| Product Code: | LZA, LZC |

### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed

| Manufacturer: | Kimberly Clark Corporation |
|----------------------|----------------------------------------------------|
| Device Name: | PURPLE NITRILE-XTRA* Powder-Free Exam - 12' Length |
| 510(k): | K113423 |
| Regulatory Class: | I |
| Classification Name: | Patient Examination Gloves (21 CFR 880.6250) |
| Product Code: | LZA, LZC |

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Image /page/5/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left with horizontal lines inside, and a white hexagon on the right with the letters "HG" in blue. The text "SRITONG GROUP" is written in a bold, blue font below the logo.

### 4.0 Description of the Device:

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs are non-sterile, lavender blue colored, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Chemotherapy drugs listed in the Intended Use(s) section below, as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.

### 5.0 Intended Use of the Device:

A powder-free 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.

In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The gloves have been tested with the following drugs and the respective breakthrough detection times are listed below.

| No. | Chemotherapy Drugs | Concentration | Breakthrough detection time<br>in Minutes |
|-----|----------------------------|---------------|-------------------------------------------|
| 1. | Blenoxane | 15 mg/ml | >240 min |
| 2. | Busulfan | 6 mg/ml | >240 min |
| 3. | Carboplatin | 10 mg/ml | >240 min |
| 4. | Carmustine (BCNU) * | 3.3 mg/ml | 30.4 min |
| 5. | Cisplatin | 1.0 mg/ml | >240 min |
| 6. | Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 min |
| 7. | Cytarabine | 100 mg/ml | >240 min |
| 8. | Dacarbazine (DTIC) | 10.0 mg/ml | >240 min |
| 9. | Daunorubicin | 5 mg/ml | >240 min |
| 10. | Docetaxel | 10.0 mg/ml | >240 min |
| 11. | Doxorubicin Hydrochloride | 2.0 mg/ml | >240 min |
| 12. | Ellence | 2 mg/ml | >240 min |
| 13. | Etoposide (Toposar) | 20.0 mg/ml | >240 min |
| 14. | Fludarabine | 25 mg/ml | >240 min |
| 15. | Fluorouracil | 50.0 mg/ml | >240 min |
| 16. | Ganciclovir | 10 mg/ml | >240 min |
| 17. | Gemcitabine (Gemzar) | 38 mg/ml | >240 min |
| 18. | ldarubicin | 1 mg/ml | >240 min |

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Image /page/6/Picture/0 description: The image shows a logo with two pink circles overlapping each other. The left circle contains four horizontal white lines. The right circle contains a white hexagon with the letters "HG" in blue. The text "SRITONG GROUP" is below the logo.

# HEALTHY GLOVE CO., L

119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: [phone] Fax: [phone]

SRITONG GROUP

| No. | Chemotherapy Drugs | Concentration | Breakthrough detection time<br>in Minutes |
|-----|---------------------|---------------|-------------------------------------------|
| 19. | Ifosfamide | 50.0 mg/ml | >240 min |
| 20. | Irinotecan | 20.0 mg/ml | >240 min |
| 21. | Mechlorethamine HCl | 1.0 mg/ml | >240 min |
| 22. | Melphalan | 5 mg/ml | >240 min |
| 23. | Methotrexate | 25 mg/ml | >240 min |
| 24. | Mitoxantrone | 2.0mg/ml | >240 min |
| 25. | Mitomycin C | 0.5 mg/ml | >240 min |
| 26. | Oxaliplatin | 5 mg/ml | >240 min |
| 27. | Paclitaxel (Taxol) | 6.0 mg/ml | >240 min |
| 28. | Rituximab | 10 mg/ml | >240 min |
| 29. | Thiotepa | 10.0 mg/ml | >240 min |
| 30. | Trisenox | 0.1 mg/ml | >240 min |
| 31. | Vincristine Sulfate | 1.0 mg/ml | >240 min |
| 32. | Vinorelbine | 10 mg/ml | >240 min |

### 6.0 Summary of Technological Characteristics Compared to the Predicate Device:

There are no different technological characteristics of the Subject Device compared to the Predicate Device.

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs are summarized with the following technological characteristics compared to ASTM D 6319 or equivalent standards as shown in Table 1.

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Image /page/7/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping pink circles. The left circle contains horizontal white lines, and the right circle contains a white hexagon with the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.

HEALTHY GLOVE CO., LTD. 119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand
Tel: [phone] Fax: [phone]

## Table 1. Side-by-Side Comparison of Predicate Device with Subject Device:

### Indications for Use, Non-clinical Performance Data and Technological Characteristics

| Characteristics | Acceptance<br>Criteria/Standards | Predicate Device:<br>510K No: 113423<br>Non-Sterile, Powder Free Nitrile<br>Examination glove, Tested for<br>use with Chemotherapy drugs<br>per ASTM D6978-05 | Subject Device:<br>(New 510(k) submission)<br>Non-Sterile, Powder Free Nitrile<br>Examination glove, Tested for use<br>with Chemotherapy drugs per<br>ASTM D6978-05 |
|---------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer(s) | | Kimberly Clark Corporation | Healthy Glove Co., Ltd |
| Indications for Use | Medical Gloves Guidance<br>Manual | A powder-free patient<br>Examination Gloves is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or finger<br>to prevent contamination<br>between patient and examiner | A powder-free patient<br>Examination Gloves is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner |
| Material | ASTM D6319-10 | Nitrile Synthetic Rubber | Nitrile Synthetic Rubber |
| Color | | Purple | Lavender Blue |
| Texture | | Textured Fingers | Textured Fingers |
| Size | Medical Glove Guidance<br>Manual-Labeling- Issued<br>on January 22, 2008 | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large |
| Single Use | Medical Gloves Guidance<br>Manual -Issued on<br>January 22, 2008 | Single use | Single use |
| Characteristics | Acceptance<br>Criteria/Standards | Predicate Device:<br>510K No: 113423<br>Non-Sterile, Powder Free Nitrile<br>Examination glove, Tested for<br>use with Chemotherapy drugs<br>per ASTM D6978-05 | Subject Device:<br>(New 510(k) submission)<br>Non-Sterile, Powder Free Nitrile<br>Examination glove, Tested for<br>use with Chemotherapy drugs<br>per ASTM D6978-05 |
| Dimension | ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| | | | Length : 270 mm minimum |
| | | | Palm Width |
| | | | Extra Small = 70 +10 mm<br>Small = 80 +10 mm<br>Medium = 95 +10 mm<br>Large = 110 +10 mm<br>Extra Large = 120 ±10 mm |
| Thickness | ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| | | | Finger: 0.10 mm minimum |
| | | | Palm: 0.10 mm minimum |
| Physical Properties | ASTM D6319-10 | Meet ASTM D6319-10 | Meet ASTM D6319-10 |
| | | | Tensile Strength: |
| | | | 14 MPa min (before aging) |
| | | | 14 MPa min (after aging) |
| | | | Ultimate Elongation: |
| | | | 500% min (before aging) |
| | | | 400% min (after aging) |
| Watertight test<br>(1000 ml) | ASTM D5151-06 | Pass | Pass AQL 1.5 |
| Residual Powder | ASTM D6124-06 | Meet<br>< 2.0 mg/glove | Meet<br>< 2.0 mg/glove |
| Biocompatibility | Primary Skin Irritation -<br>ISO 10993-10: 2010 | Pass | Pass<br>Not a primary skin irritant under<br>the conditions of the study |
| | Dermal Sensitization -<br>ISO 10993-10: 2010 | Pass | Pass<br>Not a contact sensitizer under<br>the conditions of the study |
| Characteristics | Acceptance<br>Criteria/Standards | Predicate Device:<br>510K No: 113423<br>Non-Sterile, Powder Free<br>Nitrile Examination glove,<br>Tested for use with<br>Chemotherapy drugs per<br>ASTM D6978-05 | Subject Device:<br>(New 510(k) submission)<br>Non-Sterile, Powder Free<br>Nitrile Examination glove,<br>Tested for use with<br>Chemotherapy drugs per<br>ASTM D6978-05 |
| Resistance against<br>Chemotherapy Drugs | ASTM D6978-05<br>(2013) | Breakthrough Detection Time (min) | |
| Blenoxane<br>(15 mg/ml) | | Not tested | > 240 min |
| Busulfan<br>(6 mg/ml) | | > 240 min | > 240 min |
| Carboplatin<br>(10 mg/ml) | | > 240 min | > 240 min |
| Carmustine (BCNU) *<br>(3.3 mg/ml) | | 30.7 min | 30.4 min |
| Cisplatin<br>(1.0 mg/ml) | | > 240 min | > 240 min |
| Cyclophosphamide<br>(Cytoxan)<br>(20 mg/ml) | | > 240 min | > 240 min |
| Cytarabine<br>100 mg/ml | | > 240 min | > 240 min |
| Dacarbazine (DTIC)<br>(10.0 mg/ml) | | > 240 min | > 240 min |
| Daunorubicin<br>(5 mg/ml) | | > 240 min | > 240 min |
| Docetaxel<br>(10.0 mg/ml) | | > 240 min | > 240 min |
| Doxorubicin<br>Hydrochloride<br>(2.0 mg/ml) | | > 240 min | > 240 min |
| Ellence<br>(2 mg/ml) | | > 240 min | > 240 min |
| Etoposide (Toposar)<br>(20.0 mg/ml) | | > 240 min | > 240 min |
| Fludarabine<br>(25 mg/ml) | | > 240 min | > 240 min |
| Fluorouracil<br>(50.0 mg/ml) | | > 240 min | > 240 min |
| Ganciclovir<br>(10 mg/ml) | | Not tested | > 240 min |
| Gemcitabine (Gemzar)<br>(38 mg/ml) | | > 240 min | > 240 min |
| Idarubicin<br>(1 mg/ml) | | > 240 min | > 240 min |
| Ifosfamide<br>(50.0 mg/ml) | | > 240 min | > 240 min |
| Irinotecan<br>(20.0 mg/ml) | | > 240 min | > 240 min |
| Mechlorethamine HCl<br>(1.0 mg/ml) | | > 240 min | > 240 min |
| Characteristics | Acceptance<br>Criteria/Standards | Predicate Device:<br>510K No: 113423<br>Non-Sterile, Powder Free<br>Nitrile Examination glove,<br>Tested for use with<br>Chemotherapy drugs per<br>ASTM D6978-05 | Subject Device:<br>(New 510(k) submission)<br>Non-Sterile, Powder Free<br>Nitrile Examination glove,<br>Tested for use with<br>Chemotherapy drugs per<br>ASTM D6978-05 |
| Resistance against<br>Chemotherapy Drugs | ASTM D6978-05<br>(2013) | Breakthrough Detection Time (min) | |
| Melphalan<br>(5 mg/ml) | | > 240 min | > 240 min |
| Methotrexate<br>(25 mg/ml) | | > 240 min | > 240 min |
| Mitoxantrone<br>(2.0mg/ml) | | > 240 min | > 240 min |
| Mitomycin C<br>(0.5 mg/ml) | | > 240 min | > 240 min |
| Oxaliplatin<br>(5 mg/ml) | | Not tested | > 240 min |
| Paclitaxel (Taxol)<br>(6.0 mg/ml) | | > 240 min | > 240 min |
| Rituximab<br>(10 mg/ml) | | > 240 min | > 240 min |
| Thiotepa<br>(10.0 mg/ml) | | > 240 min | > 240 min |
| Trisonex<br>(0.1 mg/ml) | | > 240 min | > 240 min |
| Vincristine Sulfate<br>(1.0 mg/ml) | | > 240 min | > 240 min |
| Vinorelbine<br>(10 mg/ml) | | Not tested | > 240 min |
| | | Please note that the following<br>drug has extremely low<br>permeation times: | *Please note that the<br>following drug has extremely<br>low permeation times: |
| | | Carmustine (BCNU) (3.3<br>mg/ml) 30.7 minutes | Carmustine (BCNU) (3.3<br>mg/ml) at 30.4 minutes |

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Image /page/8/Picture/0 description: The image shows a logo for the Sritong Group. The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.

# HEALTHY GLOVE CO., LTD.

119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand
Tel: [phone] Fax: [phone]

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Image /page/9/Picture/0 description: The image shows a logo for SRITONG GROUP. The logo consists of two pink circles that are overlapping. The left circle contains four horizontal white lines. The right circle contains a white hexagon with the letters 'HG' in blue. The text 'SRITONG GROUP' is located below the logo.

# HEALTHY GLOVE CO., LTD.

119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand
Tel: [phone] Fax: [phone]

SRITONG GROUP

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Image /page/10/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.

# HEALTHY GLOVE CO.,

119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: [phone] Fax: [phone]

### 7.0 Substantial Equivalent Based on Assessment of Non-clinical Performance Data:

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned in the previous section (ASTM Requirements).

### 8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:

No clinical testing was required to determine substantial equivalence of this device.

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Image /page/11/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" inside of a hexagon. The text "SRITONG GROUP" is written in blue below the logo.

HEALTHY GLOVE CO., LTD. 119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: [phone] Fax: [phone]

### 9.0 Conclusion:

Based on the comparison of the intended use, technological characteristics and non-clinical performance test data, the subject device, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs is substantially equivalent to the Predicate Device K113423.