Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K232764 · Eco Medi Glove Sdn. Bhd. · LZA · Feb 7, 2024 · General Hospital

Device Facts

• Record ID: K232764
• Device Name: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable nitrile rubber examination glove; cornflower blue color; powder-free; non-sterile; ambidextrous; beaded cuff; finger-textured. Used by healthcare examiners to prevent cross-contamination. Tested for permeation resistance against chemotherapy drugs and fentanyl citrate per ASTM D6978-05. Provides barrier protection; breakthrough times vary by chemical; specific warnings provided for Carmustine and Thiotepa due to low permeation resistance. Used in clinical settings; protects examiner from patient contaminants and chemical exposure.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (ISO 10993-23, ISO 10993-10, ISO 10993-11) confirmed non-irritant, non-sensitizer, and no acute systemic toxicity. Permeation testing performed per ASTM D6978-05.

Technological Characteristics

Nitrile rubber compound; powder-free; non-sterile; ambidextrous; finger-textured; beaded cuff. Dimensions and physical properties (tensile strength, elongation) meet ASTM D6319-19. Biocompatibility per ISO 10993 series. Permeation testing per ASTM D6978-05.

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Suitable for over-the-counter use. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate 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

• Cornflower Blue Powder-Free Exam Gloves with Tested for Use with Chemotherapy Drug Labeling Claim (K103249)

Reference Devices

• Intercept Free, Nitrile Two Toned White/Green, Powder-Free, Textured Fingertips, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with the Opioids Fentanyl Citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (K220375)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 7, 2024

ECO Medi Glove Sdn. Bhd Suresh Kumar QA Manager Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan 34600 Malaysia

Re: K232764

Trade/Device Name: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: December 13, 2023 Received: December 18, 2023

Dear Suresh Kumar:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Allan G

For Bifeng Qian, M.D., Ph.D. Assistant Director

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DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K232764

## Device Name

Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate

## Indications for Use (Describe)

Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate 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. It is for over-the- counter use.

In addition, these gloves were tested for use with Chemotherapy Citrate in accordance with ASTM D6978-05, Standards Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Drug Concentration | Minimum Breakthrough detection time in Minutes |
|-------------------------------------------------|------------------------------------------------|
| Carmustine (3.3mg/ml or 3000ppm) | 15.4 minutes |
| Cyclophosphamide (20mg/ml or 20,000ppm) | >240 minutes |
| Cytarabine (100mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm) | >240 minutes |
| Etoposide (20mg/ml or 20,000ppm) | >240 minutes |
| Flourouracil (50mg/ml or 50,000) | >240 minutes |
| Methorexate (25mg/ml or 25,000ppm) | >240 minutes |
| Paclitaxel (6mg/ml or 6,000ppm) | >240 minutes |
| Thiotepa (10mg/ml or 10,000ppm) | 56.2 minutes |
| Fentanyl Citrate Injection (100mg/2ml) | >240 minutes |

The maximum testing time is 240 minutes.

Please note that the following drugs have extremely low permeation time.

- Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 15.4 minutes.
- Thiotepa (10ug/ml) Minimum Breakthrough detection time 56.2 minutes.

WARNING: Not for use with Carmustine and ThioTepa

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)

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**ECO Medi Glove Sdn. Bhd.** (815262-D)

Plant 1: Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
Plant 2: Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

[e-mail] Website: www.ecomediglove.com.
06 2216
FAX: [phone]

TEL [phone]
SST NO.: A11-1808-21015730

FAX [phone]

K232764 510(K) Summary

## Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

### 1.0 Submitter:

| Company Name | : | ECO Medi Glove Sdn. Bhd. |
|-----------------|---|---------------------------------------------------------------------------------------------------------------------------|
| Company Address | : | Lot 23826, Jalan Tembaga Kuning,<br>Kamunting Raya Industrial Estate,<br>34600 Taiping, Perak Darul Ridzuan,<br>Malaysia. |
| Contact Person | : | Mr. Suresh Kumar |
| Telephone | : | [phone] |
| Fax | : | [phone] |
| Email | : | [e-mail] |

- 2.0 7th February 2024 Preparation Date :
### 3.0 Name of the Device

Trade Name / Proprietary Name: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Device Name: Nitrile Patient Examination gloves.

Device Classification Name: Patient Examination gloves (21 CFR 880.6250).

Device Class: Class I.

Product Code: LZA, LZC, OPJ and QDO

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

Plant 1: Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

Plant 2: Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.r

TEL [phone] FAX [phone]

SST NO.: A11-1808-21015730

## 4.0 Identification of The Legally Marketed Device:

Predicate Device: K103249, Cornflower Blue Powder-Free Exam Gloves with Tested for Use with Chemotherapy Drug Labeling Claim

Reference Device: K220375, Intercept Free, Nitrile Two Toned White/Green, Powder- Free, Textured Fingertips, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with the Opioids Fentanyl Citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

### 5.0 Device Description

The subject device in this 510(k) Notification is a Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. The subject device is a patient examination glove made from nitrile rubber compound, Cornflower Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and fentanyl citrate.

### 6.0 Indications for Use

Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. It is for over-thecounter use.

In addition, these gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Fentanyl Citrate<br>Concentration | Minimum Breakthrough<br>detection time in Minutes |
|---------------------------------------------------------|---------------------------------------------------|
| Carmustine (3.3mg/ml or 3000ppm), | 15.4 minutes |
| Cyclophosphamide (20mg/ml or 20,000ppm), | >240 minutes |
| Cytarabine (100mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), | >240 minutes |
| Etoposide (20mg/ml or 20,000ppm), | >240 minutes |
| Flourouracil (50mg/ml or 50,000), | >240 minutes |

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Plant 1: Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

Plant 2: Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

| Methorexate (25mg/ml or 25,000ppm), | >240 minutes |
|--------------------------------------|--------------|
| Paclitaxel (6mg/ml or 6,000ppm), | >240 minutes |
| Thiotepa (10mg/ml or 10,000ppm), | 56.2 minutes |
| Fentanyl Citrate Injection 100mg/2ml | >240 minutes |

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.

Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 15.4 minutes. Thiotepa (10ug/ml) - Minimum Breakthrough detection time 56.2 minutes.

WARNING: Not for use with Carmustine and ThioTepa

### 7.0 Specification for Nitrile exam gloves (ASTM D6319-19):

### Dimension and Thickness of Gloves 7.1

| Dimension | Size<br>XXS | Size XS | Size S | Size M | Size L | Size XL | Size<br>XXL |
|---------------------------------|-------------|---------|---------|---------|---------|---------|-------------|
| Overall Length (mm) | N/A | 220min | 220min | 230min | 230min | 230min | 230min |
| Width (± 10mm) | N/A | 70 | 80 | 95 | 110 | 120 | 130 |
| Thickness at Palm (mm) | N/A | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min |
| Thickness at Finger Tip<br>(mm) | N/A | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min |

### 7.2 Gloves Physical Properties and Holes

| Measurement | Before Ageing | After Aging at 70°C for<br>168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|-------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>Inspection Level G-1 |

Gloves meet all the specifications listed in ASTM D 6319-19

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# ECO Medi Glove Sd

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA

Plant 2 : Lot 23826, Jalan Tembaga Kuning Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.my

TEL [phone] FAX [phone]

SST NO. : A11-1808-21015730

# Comparison of Proposed and Predicate Device

| Characteristics | Acceptance Criteria | Cornflower Blue<br>Powder Free Nitrile<br>Examination Glove<br>Tested for Use with<br>Chemotherapy<br>Drugs and Fentanyl<br>Citrate<br>(subject device) | Predicate Device<br>Cornflower Blue<br>Powder-Free Exam<br>Gloves with Tested<br>for Use with<br>Chemotherapy Drug<br>Labeling Claim<br>K103249 | Reference Device<br>Intercept Free, Nitrile<br>Two Toned<br>White/Green, Powder-<br>Free, Textured<br>Fingertips, Non-sterile,<br>Ambidextrous, Beaded<br>Cuff, Medical<br>Examination Gloves,<br>Tested for Use with the<br>Opioids Fentanyl<br>Citrate, Heroin, and<br>both Opioids in<br>simulated Gastric Acid<br>(Vomit)<br>K220375 | Assessment<br>Similarities and<br>Differences |
|--------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | |
| Product Code | | LZA, LZC, OPJ and<br>QDO | LZA, LZC | LZA, LZC, QDO | Same |
| Intended use | | A powder-free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the-counter use. | A powder-free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hand or finger to<br>prevent contamination<br>between patient and<br>examiner. The device<br>is for over-the-counter<br>use. | A Nitrile powder free<br>medical examination<br>glove is a disposable<br>device, worn on the hand<br>or finger to prevent<br>contamination between<br>examiner and patient or<br>victim. This specialty<br>glove has also been<br>tested for use with the<br>Opioid drugs fentanyl<br>citrate, Heroin, and both<br>Opioid in simulated<br>Gastric Acid. | Similar Except the<br>reference device<br>glove intended use<br>statement was<br>extended to<br>address the opioid<br>drug Heroin and<br>gastric acid |
| Material use | Nitrile compound | Nitrile compound | Nitrile compound | Nitrile compound | Same |
| Color | | Cornflower Blue | Cornflower Blue | White<br>Outside/Lime<br>Green inside | Same |
| Sterility | Non sterile | Non sterile | Non sterile | Non sterile | Same |
| Single use | Single use | Single use | Single use | Single use | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Surface | Finger Textured | Finger Textured | Finger Textured | Finger Textured | Same |
| Cuffing<br>Beading | Rolled Beading | Rolled Beading | Rolled Beading | Rolled Beading | Same |
| Design | Ambidextrous | Ambidextrous | Ambidextrous | Ambidextrous | Same |

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# ECO Medi Glove Sdn. Bhd. (815262-D)

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

Plant 2 : Lot 23826, Jalan Tembaga Kuning Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.my

TEL [phone]

FAX [phone]

| SST NO. : A11-1808-21015730 | |
|-----------------------------|--|
| | |

| Dimensions | Overall Length (mm)<br>XS, S: Min 220mm<br>M, L, XL, XXL:<br>Min 230mm<br>Width (±10mm) | Overall Length (mm)<br>Min 230mm<br>Width (± 10mm) | Meets sizes<br>specified in ASTM<br>D6319. | Meets sizes specified<br>in ASTM D6319. | Different: Subject<br>device sizes meet<br>ASTM D6319-19 with<br>addition of XXS. |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------|
| | Sizes :<br>Extra Extra Small<br>(XXS) = 65mm<br><br>Extra Small (XS) =<br>70mm<br><br>Small (S) = 80mm<br><br>Medium (M) = 95mm<br><br>Large (L) = 110mm<br><br>Extra Large (XL)<br>= 120mm<br><br>Double Extra Large<br>(XXL) = 130mm | Sizes:<br>Extra Extra Small<br>(XXS) = 65mm<br><br>Extra Small (XS)=<br>70mm<br><br>Small (S) = 80mm<br><br>Medium = 95mm<br><br>Large (L) = 110mm<br><br>Extra Large (XL) =<br>120mm<br><br>Double Extra Large<br>(XXL) = 130mm | | | |
| | Thickness at<br>Palm (mm) Min;<br>0.05 mm Thickness<br>at Finger Tip (mm)<br>Min 0.05 mm | Thickness at<br>Palm (mm) Min;<br>0.05 mm<br>Thickness at<br>Finger Tip (mm)<br>Min 0.05 mm | | | |

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

# ECO Medi Glove Sdn. Bhd. (815262-D)

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

Plant 2 : Lot 23826, Jalan Tembaga Kuning Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.my

TEL [phone]

FAX [phone]

## SST NO. : A11-1808-21015730

| Physical<br>properties | Before Ageing<br>Tensile Strength<br>(MPa)<br>= 14min<br>Ultimate<br>Elongation (%)<br>= 500min<br>After Aging at<br>70°C for<br>168 hrs @ 100°C<br>for 22 hrs<br>Tensile Strength<br>(MPa)<br>= 14min<br>Ultimate<br>Elongation (%)<br>= 400min | Meets ASTM D6319-19 | Meets ASTM D6319-19 | Meets ASTM D6319-19 | Same |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------|
| Freedom from<br>pinholes | AQL 2.5<br>Inspection Level<br>G-1 | Meets<br>ASTM D5151-19 | Meets<br>ASTM D5151-19 | Meets<br>ASTM D5151-19 | Same |
| Residual Powder | ≤2.0 mg/pc | Meets<br>ASTM D6124-<br>06(2022) | Meets<br>ASTM D6124-<br>06(2022) | Meets<br>ASTM D6124-06(2022) | Same |
| Biocompatibility | ISO 10993-23:<br>2021<br>Biological<br>evaluation of<br>medical devices-<br>Part 23: Test for<br>irritation | Under the conditions of<br>this study, the test<br>article was a non-<br>irritant. | Under the conditions<br>of this study, the test<br>article was a non-<br>irritant. | Under the conditions of<br>this study, the test article<br>was a non-irritant. | Same |
| | ISO 10993-10:<br>2021 Biological<br>Evaluation on<br>Medical Device –<br>Part 10:<br>Test for Skin<br>Sensitization | Under the conditions of<br>this study, the test<br>article was a non-<br>sensitizer. | Under the conditions<br>of this study, the test<br>article was a non-<br>sensitizer. | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. | Same |
| | ISO 10993-11<br>Biological<br>evaluation on<br>medical device Part<br>11 – Test for<br>systemic toxicity | Not induce any acute<br>systemic toxicity | Not induce any<br>acute systemic<br>toxicity | Not induce any acute<br>systemic toxicity | Same |

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# O Medi Glove Sdn. Bhd.

600 Taiping. Perak Darul Ridzuan, MALAYSIA

amunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA + 73876 lalan Temna

[e-mail] site: www.ecomedialove.com.my

60-5-806 2316

Resistance

Drugs and

against

5

FAX [phone]

| . | ST NO. : A11-1808-21015730 |
|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 10 m . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . |

Standards Practice 1) Carmustine 1) Carmustine Tested with: Fentanyl Similar: Subject for Assessment of (BCNU) 3.3mg/ml (BCNU) 3.3mg/ml citrate (Injectable): Device was tested Chemotherany resistance of 15.4 minutes 7.28 minutes 100mg/2mil: No with the same Medical Glove to 2) Cyclophosphamide 2) Cisplatin breakthrough time at 240 chemicals as the (Cytoxan) 1.0mg/mL, >240 Fentanyl Citrate Permeation by minutes predicate except Chemotherapy (20mg/ml) minutes with the addition of drugs ASTM >240 minutes 3) Cyclophosphamide Heroin saturated in fentanyl citrate D6978-05(2019) 3) Cytarabine HCI (Cytoxan) injectable Fentanyl No (reference device). (100mg/ml) (20mg/ml) breakthrough time at >240 minutes >240 minutes 240 minutes 4) Doxorubicin HCI 4) Doxorubicin HCI (2.0mg/ml) (2.0mg/ml) And both opioid drugs >240 minutes >240 minutes Fentanyl and Heroin 5) Etoposide 5) Etoposide mixed with simulated (20.0mg/ml (20.0mg/ml gastric acid: represents >240 minutes >240 minutes opioid-contaminated 6) Fluorouracil 6) 5-Fluorouracil vomit from overdose (50.0mg/ml) (50.0mg/ml) victims. >240 minutes >240 minutes No breakthrough time at 7) 7) Methotrexate 240 minutes (25mg/ml) (25mg/ml) >240 minutes >240 minutes 8) Paclitaxel 8) Paclitaxel (6.0mg/ml) (6.0mg/ml) >240 minutes >240 minutes 9) ThioTepa 9) ThioTepa (10.0mg/ml) (10.0mg/ml) 56.2 minutes 2.67 minutes Tested with: Fentanyl Warning : Not for use Citrate (Injection), with Carmustine or 100mg/2ml: no Thio Tepa breakthrough time at 240 minutes 240 minutes

Warning: Not for use with Carmustine or

Thio Tepa

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# ECO Medi Glove Sdn. Bh

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA Plant 2 : Lot 23826, Jalan Tembaga Kuning Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.my

TEL [phone] SST NO. : A11-1808-21015730 FAX [phone]

## 8.0 Summary of Non-Clinical Testing

| Characteristics | Test Standard | Acceptance Criteria | Test Result |
|----------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Freedom from<br>Pin holes | ASTM D5151 -19<br>(Re-approved 2011) | AQL 2.5<br>Inspection Level G-1 | Meets<br>ASTM D5151-19 |
| Dimensions | ASTM D6319 -19 | Length<br>XS, X: Min 220mm<br>M, L, XL, XXL: Min 230mm | Meets<br>ASTM D6319-19 |
| | ASTM D6319 -19 | Width<br>Size XXS = 65mm±10<br>(Internal<br>Requirement)<br>Size XS = 70mm±10<br>Size S = 80mm±10<br>Size M = 95mm±10<br>Size L = 110mm±10<br>Size XL = 120mm±10<br>Size XXL =130mm±10 | ISO 2859-1 /<br>S2/AQL 4.0 |
| | ASTM D6319 -19 | Thickness at Palm (mm)<br>Min: 0.05 mm | ISO 2859-1 /<br>S2/AQL 4.0 |
| | | Thickness at Finger Tip<br>(mm) Min: 0.05 mm | |
| | | | |
| Physical<br>properties | ASTM D6319 -19<br>ASTM D412-16(2021) | Before Ageing<br>Tensile Strength (MPa)<br>= 14min<br>Ultimate Elongation (%)<br>= 500min | Meets ASTM<br>D6319-19 |
| | ASTM D6319 -19 and<br>ASTM D412-06(2021) | After Aging at 70°C for<br>168 hrs @ 100°C for 22 hrs<br>Tensile Strength (MPa)<br>= 14min<br>Ultimate Elongation (%)<br>= 400min | |
| | | | |
| | | | |
| | | | |
| Powder-free<br>residue | ASTM D6124-06(2022) | ≤2.0 mg/pc | Meets<br>ASTM D6124-06<br>(2022) |
| Irritation | ISO 10993-23:2021 | Not an irritant | Pass |
| Sensitization | ISO 10993-10:2021 | Not a sensitizer | Pass |
| Acute Systemic<br>Toxicity | ISO 10993-11:2017 | Not induce acute systemic<br>toxicity | Pass |

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aiping. Perak Darul Ridzuan. MALAYSIA

iping. Perak Darul Ridzuan. MALAYSIA

NO. : A11-1808-210157

## 8.0 Summary of Clinical Testing

N/A.

## 9.0 Conclusion

The Conclusions drawn from the non-clinical tests demonstrate that the subject device, Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K103249.