Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

K173942 · Central Medicare Sdn Bhd · LZC · Mar 5, 2018 · General Hospital

Device Facts

• Record ID: K173942
• Device Name: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
• Applicant: Central Medicare Sdn Bhd
• Product Code: LZC · General Hospital
• Decision Date: Mar 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

Device Story

Disposable nitrile examination gloves; worn by clinicians to prevent cross-contamination between patient and examiner. Device provides barrier protection during medical examinations and handling of chemotherapy drugs. Input: physical contact with patients or chemotherapy agents. Operation: passive barrier protection. Output: physical barrier. Used in clinical settings by healthcare professionals. Benefits: reduces risk of contamination and exposure to hazardous chemotherapy agents. Tested for permeation resistance against 36 specific chemotherapy drugs per ASTM D6978-05.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including physical properties (tensile strength, elongation), freedom from holes (ASTM D5151-06), residual powder (ASTM D6124-06), biocompatibility (ISO 10993-10), and chemotherapy drug permeation resistance (ASTM D6978-05).

Technological Characteristics

Material: Nitrile synthetic latex. Design: Ambidextrous, powder-free, blue color. Dimensions: Length min 230mm; thickness 0.06mm (cuff), 0.08mm (palm), 0.10mm (finger). Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ASTM D412-16, ASTM D573-04, ASTM D6978-05, ISO 2859-1, ISO 10993-10. Non-sterile. Standalone device.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable 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

• Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services - USA logo. The second logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

March 5, 2018

Central Medicare Sdn. Bhd. Arivalagan Subramaniam QA/RA Manager PT 2609-2620, BT 8, Jalan Changkat Jong Teluk Intan, 36000 My

Re: K173942

Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: December 27, 2017 Received: January 2, 2018

Dear Arivalagan Subramaniam:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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## Indications for Use

### 510(k) Number (if known)

### K173942

### Device Name

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

### Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves:

| Tested Chemotherapy Drug | Concentrate(mg/ml) | Minimum Breakthrough Detection Time (minutes) |
|---------------------------|--------------------|-----------------------------------------------|
| Bleomycin Sulfate | 15 | >240 |
| Busulfan | 6 | >240 |
| Carboplatin | 10 | >240 |
| Carmustine | 3.3 | 12.4 |
| Cisplatin | 1 | >240 |
| Chloroquine | 50 | >240 |
| Cyclophosphamide | 20 | >240 |
| Cyclosporin | 100 | >240 |
| Cytarabine HCI | 100 | >240 |
| Dacarbazine | 10 | >240 |
| Daunorubicin HCI | 5 | >240 |
| Docetaxel | 10 | >240 |
| Doxorubicin Hydrochloride | 2 | >240 |
| Epirubicin (Ellence) | 2 | >240 |
| Etoposide | 20 | >240 |
| Fludarabine | 25 | >240 |
| Fluorouracil | 50 | >240 |
| Gemcitabine | 38 | >240 |
| Idarubicin | 1 | >240 |
| Ifosfamide | 50 | >240 |
| Irinotecan | 20 | >240 |
| Mechlorethamine HCI | 1 | >240 |
| Melphalan | 5 | >240 |
| Methotrexate | 25 | >240 |
| Mitomycin | 0.5 | >240 |
| Mitoxantrone | 2 | >240 |
| Oxaliplatin | 5 | >240 |
| Paclitaxel | 6 | >240 |
| Paraplatin | 10 | >240 |
| Retrovir | 10 | >240 |
| Rituximab | 10 | >240 |
| Thiotepa | 10 | 24.4 |
| Topotecane | 1 | >240 |

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| Trisonex | 1 | >240 |
|---------------------|---|------|
| Velcade | 1 | >240 |
| Vincristine Sulfate | 1 | >240 |

*Please note that the following drugs have extremely low permeation times:

Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: [phone] Fax: [phone]

## 510(k) Summary

### 510(k) Number: K173942

### Date Prepared: 5th March 2018

### 1.0 Submitter:

| Name: | Arivalagan Subramaniam<br>QA/RA Manager | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------|--|--|
| Address: | Central Medicare Sdn. Bhd.<br>PT 2609-2620, Batu 8,<br>Jalan Changkat Jong, 36000 Teluk Intan,<br>Perak, Malaysia | | |
| Contact: | Tel: [phone] Fax: [phone] | | |
| 510(k) Submission Prepared by: | Muhammad Abdul Rahman<br>Regulatory Affairs Officer<br>Central Medicare Sdn. Bhd. | | |

### 2.0 Name of the device:

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

| Common Names: | Chemotherapy Gloves, Exam Gloves | |
|-----------------------|------------------------------------------------------------------------------|--|
| Device Class: | Class I | |
| Classification Names: | Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC, LZA) | |

### 3.0 Identification of the Legally Marketed Devices that equivalency is claimed:

| Trade Name: | Blue Non Sterile Powder Free Nitrile<br>Examination Gloves Tested for Use with<br>Chemotherapy Drugs |
|------------------------------------|------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K173942 |
| Predicate Device<br>510(k) Number: | K172525 |

### 4.0 Description of The Device:

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large.

Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.

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PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: [phone] Fax: [phone]

## 510(k) Summary

### 5.0 Indications for Use

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

### Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves:

| Tested Chemotherapy Drug | Concentrate (mg/ml) | Minimum Breakthrough<br>Detection Time (minutes) |
|---------------------------|---------------------|--------------------------------------------------|
| Bleomycin Sulfate | 15 | >240 |
| Busulfan | 6 | >240 |
| Carboplatin | 10 | >240 |
| Carmustine | 3.3 | 12.4 |
| Cisplatin | 1 | >240 |
| Chloroquine | 50 | >240 |
| Cyclophosphamide | 20 | >240 |
| Cyclosporin | 100 | >240 |
| Cytarabine HCI | 100 | >240 |
| Dacarbazine | 10 | >240 |
| Daunorubicin HCI | 5 | >240 |
| Docetaxel | 10 | >240 |
| Doxorubicin Hydrochloride | 2 | >240 |
| Epirubicin (Ellence) | 2 | >240 |
| Etoposide | 20 | >240 |
| Fludarabine | 25 | >240 |
| Fluorouracil | 50 | >240 |
| Gemcitabine | 38 | >240 |
| Idarubicin | 1 | >240 |
| Ifosfamide | 50 | >240 |
| Irinotecan | 20 | >240 |
| Mechlorethamine HCI | 1 | >240 |
| Melphalan | 5 | >240 |
| Methotrexate | 25 | >240 |
| Mitomycin | 0.5 | >240 |
| Mitoxantrone | 2 | >240 |
| Oxaliplatin | 5 | >240 |
| Paclitaxel | 6 | >240 |
| Paraplatin | 10 | >240 |
| Retrovir | 10 | >240 |
| Rituximab | 10 | >240 |
| Thiotepa | 10 | 24.4 |
| Topotecane | 1 | >240 |
| Trisonex | 1 | >240 |
| Velcade | 1 | >240 |
| Vincristine Sulfate | 1 | >240 |

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PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: [phone] Fax: [phone]

## 510(k) Summary

*Please note that the following drugs have extremely low permeation times: Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes

### 6.0 Summary of the Technological Characteristics of the Device:

The proposed and predicate devices all share the same technological characteristics and design by meeting ASTM D6319-10 and following the FDA's Medical Glove Guidance Manual.

The purpose of this submission is to gain premarket clearance for the proposed device as a specialty chemotherapy glove and patient examination glove by proving substantial equivalence to Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525) as a predicate device. The proposed device will also be known as Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.

Biocompatibility studies were performed on the proposed device. Under the conditions of the study, the proposed device is not a sensitizer, or an irritant.

The proposed and predicate devices are made of nitrile synthetic latex. The proposed device have similar technological characteristics compared to the predicate devices, as both devices meet ASTM D6319-10 and follow FDA's Medical Glove Guidance Manual. The technological characteristics and design for the proposed device have been assessed and confirmed that the standard specifications and performance are appropriate for the requirements of powder free nitrile examination gloves and specialty chemotherapy aloves.

The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs of the proposed and predicate devices.

| | Proposed Device | Predicate Device | Remark |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Sponsor | Central Medicare Sdn. Bhd.<br>(as both the sponsor and manufacturer) | Central Medicare Sdn. Bhd.<br>(as both the sponsor and manufacturer) | Same |
| Trade Name | Blue Non Sterile Powder Free Nitrile Examination<br>Gloves Tested for Use with Chemotherapy Drugs | Blue Non Sterile Powder Free Nitrile Examination<br>Gloves Tested for Use with Chemotherapy Drugs | Same |
| 510k Number | K173942 | K172525 | Same |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | | | Same |
| Indications for Use | Blue Non Sterile Powder Free Nitrile Examination<br>Gloves Tested for Use with Chemotherapy Drugs<br>is a disposable device intended for medical<br>purposes that is worn on the examiner's hands to<br>prevent contamination between patient and<br>examiner. | Blue Non Sterile Powder Free Nitrile Examination<br>Gloves Tested for Use with Chemotherapy Drugs<br>is a disposable device intended for medical<br>purposes that is worn on the examiner's hands to<br>prevent contamination between patient and<br>examiner. | Same |
| Powder or Powder<br>Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | Blue | Same |
| Labeling<br>Information | Single-use indication, powder free, device name,<br>glove size, quantity, Nitrile Examination Gloves,<br>Non Sterile | Single-use indication, powder free, device name,<br>glove size, quantity, Nitrile Examination Gloves,<br>Non Sterile | Same |

### General Comparison Table:

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PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: [phone] Fax: [phone]

## 510(k) Summary

## Chemotherapy Drug Permeation Claim:

| | Proposed Device | Predicate Device | Remark |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Sponsor | Central Medicare Sdn. Bhd.<br>(as both the sponsor and manufacturer) | Central Medicare Sdn. Bhd.<br>(as both the sponsor and manufacturer) | Same |
| Chemotherapy Drug<br>Permeation Claim | Bleomycin Sulfate, Busulfan, Carboplatin,<br>Carmustine, Cisplatin, Chloroquine,<br>Cyclophosphamide, Cyclosporin, Cytarabine HCI,<br>Dacarbazine, Daunorubicin HCI, Docetaxel,<br>Doxorubicin Hydrochloride, Epirubicin (Ellence),<br>Etoposide, Fludarabine, Fluorouracil,<br>Gemcitabine, Idarubicin, Ifosfamide, Irinotecan,<br>Mechlorethamine HCI, Melphalan, Methotrexate,<br>Mitomycin, Mitoxantrone, Oxaliplatin, Paclitaxel,<br>Paraplatin, Retrovir, Rituximab, Thiotepa,<br>Topotecane, Trisonex, Velcade and Vincristine<br>Sulfate | Fluorouracil, Etoposide (Toposar),<br>Cyclophosphamid (Cytoxan), Carmustine<br>(BCNU), Thiotepa, Paclitaxel (Taxol), Doxorubicin<br>Hydrochloride, Dacarbazine (DTIC), Cisplatin,<br>Ifosfamide, Mitoxantrone, Vincristine Sulfate | Proposed<br>Device Tested<br>24 More Drugs |

## Device Dimensions Table:

| Proposed Device | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------|----------------|----------------|----|----|-----|-----|-------|
| | | Size | | | | | |
| Blue Non Sterile Powder<br>Free Nitrile Examination<br>Gloves Tested for Use<br>with Chemotherapy Drugs<br>(K173942) | Length (mm) | minimum 230 | | | | | |
| | Width (mm) | 70 | 80 | 95 | 110 | 120 | ±10 |
| | | Thickness (mm) | | | | | |
| | Cuff | 0.06 | | | | | ±0.03 |
| | Palm | 0.08 | | | | | ±0.03 |
| | Finger | 0.10 | | | | | ±0.03 |
| Predicate Device | | | | | | | |
| | | Size | | | | | |
| Blue Non Sterile Powder<br>Free Nitrile Examination<br>Gloves Tested for Use<br>with Chemotherapy Drugs<br>(K172525) | Length (mm) | minimum 230 | | | | | |
| | Width (mm) | 70 | 80 | 95 | 110 | 120 | ±10 |
| | Thickness (mm) | | | | | | |
| | Cuff | 0.06 | | | | | ±0.03 |
| | Palm | 0.08 | | | | | ±0.03 |
| | Finger | 0.10 | | | | | ±0.03 |

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## central medicare sdn. Bhd. (660896 T)

PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: [phone] Fax: [phone]

## 510(k) Summary

### Performance Comparison Table:

| Item | Proposed Device | | Predicate Device | | Remark |
|------------------------|-----------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------|
| | | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942) | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525) | | |
| | Color | Blue | Blue | | Same |
| Physical<br>Properties | Before<br>Aging | Tensile Strength | 15 Mpa min | 15 Mpa min | Same |
| | Aging | Ultimate Elongation | 500% min | 500% min | Same |
| | After<br>Aging | Tensile Strength | 14 Mpa min | 14 Mpa min | Same |
| | Aging | Ultimate Elongation | 400% min | 400% min | Same |
| Freedom from Holes | | | In accordance with ASTM D5151-06, following ASTM D6319 AQL 2.5/Inspection Level G-I | In accordance with ASTM D5151-06, following ASTM D6319 AQL 2.5/Inspection Level G-I | Same |
| Powder Content | | | Avg. 0.44 mg per glove | Avg. 0.52 mg per glove | Same |

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PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: [phone] Fax: [phone]

## 510(k) Summary

## Chemotherapy Permeation Comparison Claim:

| Chemotherapy Drug Testing - ASTM D6978-05 | | | | |
|-------------------------------------------|---------------------|---------------------------------------------------------------|------------------|------------|
| Tested Chemotherapy Drug | Concentrate (mg/ml) | Proposed Device Minimum Breakthrough Detection Time (minutes) | Predicate Device | Remark |
| Bleomycin Sulfate | 15 | >240 | Not Tested | Additional |
| Busulfan | 6 | >240 | Not Tested | Additional |
| Carboplatin | 10 | >240 | Not Tested | Additional |
| Carmustine | 3.3 | 12.4 | 12.4 | Same |
| Cisplatin | 1 | >240 | >240 | Same |
| Chloroquine | 50 | >240 | Not Tested | Additional |
| Cyclophosphamide | 20 | >240 | >240 | Same |
| Cyclosporin | 100 | >240 | Not Tested | Additional |
| Cytarabine HCI | 100 | >240 | Not Tested | Additional |
| Dacarbazine | 10 | >240 | >240 | Same |
| Daunorubicin HCI | 5 | >240 | Not Tested | Additional |
| Docetaxel | 10 | >240 | Not Tested | Additional |
| Doxorubicin Hydrochloride | 2 | >240 | >240 | Same |
| Epirubicin (Ellence) | 2 | >240 | Not Tested | Additional |
| Etoposide | 20 | >240 | >240 | Same |
| Fludarabine | 25 | >240 | Not Tested | Additional |
| Fluorouracil | 50 | >240 | >240 | Same |
| Gemcitabine | 38 | >240 | Not Tested | Additional |
| Idarubicin | 1 | >240 | Not Tested | Additional |
| Ifosfamide | 50 | >240 | >240 | Same |
| Irinotecan | 20 | >240 | Not Tested | Additional |
| Mechlorethamine HCI | 1 | >240 | Not Tested | Additional |
| Melphalan | 5 | >240 | Not Tested | Additional |
| Methotrexate | 25 | >240 | Not Tested | Additional |
| Mitomycin | 0.5 | >240 | Not Tested | Additional |
| Mitoxantrone | 2 | >240 | >240 | Same |
| Oxaliplatin | 5 | >240 | Not Tested | Additional |
| Paclitaxel | 6 | >240 | >240 | Same |
| Paraplatin | 10 | >240 | Not Tested | Additional |
| Retrovir | 10 | >240 | Not Tested | Additional |
| Rituximab | 10 | >240 | Not Tested | Additional |
| Thiotepa | 10 | 24.4 | 24.4 | Same |
| Topotecane | 1 | >240 | Not Tested | Additional |
| Trisonex | 1 | >240 | Not Tested | Additional |
| Velcade | 1 | >240 | Not Tested | Additional |
| Vincristine Sulfate | 1 | >240 | >240 | Same |

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

PT 2609 - 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: [phone] Fax: [phone]

## 510(k) Summary

### 7.0 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 immediately above, and all mentioned devices follow ASTM D6319-10 reguirements and FDA's Medical Glove Guidance Manual.

The proposed device and it's predicate devices share intended use, are made of the same material, are within the same minimum specifications of thickness and length by meeting ASTM D6319-10, similar permeation rates for chemotherapy drugs as per ASTM D6978-05, similar labeling, physical properties, freedom from powder, biocompatibility and water tightness and by following the same quidance – FDA's Medical Glove Guidance Manual. Therefore, the proposed device is substantially equivalent to the predicate.

The test results demonstrated that the proposed device complies with the following standards:

ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Guidance for Industry and FDA Staff Medical Glove Guidance Manual (Document issued on January 22, 2008)

The following standards were followed to carry out the testing:

ASTM D5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.

ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension

ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves

ASTM D573 - 04 Standard Test Method for Rubber—Deterioration in an Air Oven ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

### 8.0 Based on Assessment of Clinical Performance Data

N/A

### 9.0 Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525).