Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

K221350 · Rubberex Alliance Products Sdn Bhd · LZA · Aug 5, 2022 · General Hospital

Device Facts

• Record ID: K221350
• Device Name: Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
• Applicant: Rubberex Alliance Products Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Aug 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Single-use, disposable, non-sterile nitrile examination gloves; worn by healthcare examiners to prevent cross-contamination; manufactured from synthetic copolymer of acrylonitrile and butadiene with blue color additive; features ambidextrous design, textured fingertips, and beaded cuff; tested for permeation resistance against nine chemotherapy drugs per ASTM D6978-05 (2019); provides barrier protection in clinical settings; output is physical protection for the wearer; benefits include reduced risk of exposure to patient contaminants and specific chemotherapy agents.

Clinical Evidence

No clinical data. Bench testing only. Conformance demonstrated via ASTM D6319-19 (dimensions), ASTM D412-16 (tensile/elongation), ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy permeation). Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity) confirmed safety despite severe reactivity at 100% concentration in cytotoxicity testing.

Technological Characteristics

Material: Synthetic copolymer of acrylonitrile and butadiene (nitrile). Design: Ambidextrous, textured fingertips, beaded cuff. Dimensions: XS-XL sizes, thickness min 0.05mm. Standards: ASTM D6319-19, ASTM D412-16, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05. Biocompatibility: ISO 10993-5, 10, 11. Non-sterile, single-use, disposable.

Indications for Use

Indicated for use as a protective barrier on the examiner's hands to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs per ASTM D6978-05 (2019). Warning: Do not use with Carmustine and Thiotepa.

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

• Uweport Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K213227)

Submission Summary (Full Text)

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August 5, 2022

Rubberex Alliance Products Sdn Bhd % Kewin Tham Official Correspondent Mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021

Re: K221350

Trade/Device Name: Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: May 9, 2022 Received: May 10, 2022

Dear Kewin Tham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221350

### Device Name

Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

### Indications for Use (Describe)

Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, singleuse, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been

tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

List of Drugs tested concentration and breakthrough detection time in maximum testing time is 240 minutes.

| Drug Tested | Concentration | Breakthrough Detection Time in Minutes |
|-----------------------------|----------------------|----------------------------------------|
| Carmustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 |
| Cisplatin | 1.0 mg/mL (1000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan®) | 20 mg/mL (20000 ppm) | > 240 |
| Dacarbazine (DTCI) | 10 mg/mL (10000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL (2000 ppm) | > 240 |
| Etoposide (ToposarⓇ) | 20 mg/mL (20000 ppm) | > 240 |
| Fluorouracil | 50 mg/mL (50000 ppm) | > 240 |
| Paclitaxel (Taxol®) | 6.0 mg/mL (6000 ppm) | > 240 |
| Thiotepa | 10 mg/mL (10000 ppm) | 15.0 |

Warning: Do not use with Carmustine and Thiotepa.

Please note that the following drugs have low permeation times:

| Camustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 minutes |
|------------------|------------------------|--------------|
| Thiotepa | 10.0 mg/mL (10000 ppm) | 15.0 minutes |

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

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) SUMMARY

## K221350 Date Summary Prepared: 29 July 2022

#### 1. Submitter's Identification:

| a. Applicant: | RUBBEREX ALLIANCE SDN BHD<br>Lot 138201 Off ¾ Mile, Jalan Bercham<br>Kawasan Perindustrian Bercham<br>31400 Ipoh, Perak, Malaysia |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. Applicant Contact Person: | Sabri Bin Abdul Hamid<br>Lot 138201 Off ¾ Mile, Jalan Bercham<br>Kawasan Perindustrian Bercham<br>31400 Ipoh, Perak, Malaysia |
| c. Official 510k Correspondent: | Ms. Kewin Tham<br>Official Contact for RUBBEREX ALLIANCE SDN BHD |
| d. Official 510k Correspondent Firm | Mdi Consultants, Inc<br>55 Northern Blvd. Suite 200<br>Great Neck, New York 11021<br>[phone]<br>Fax: [phone]<br>Email: [e-mail] |

### 2. Name of the Device:

Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

| Regulation Number: | 21 CFR 880.6250 |
|--------------------|----------------------------------------|
| Regulation Name: | Non-Powdered Patient Examination Glove |
| Regulatory Class: | Class I, reserved |
| Product Code: | LZA, LZC, OPJ |

#### 3. Information for the 510(k) Cleared Device (Predicate Device):

| Predicate device: | K213227 |
|-----------------------------|---------------------------------------------------------------|
| Trade/Device Name: | Uweport Powder-Free Nitrile Examination Gloves Tested for Use |
| | with Chemotherapy Drugs |
| Device Classification Name: | Non-Powdered Patient Examination gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Device Class: | Class I |
| Product Code: | LZA, LZC, OPJ |
| Applicant name: | Uweport LLC. |

#### 4. Device Description:

The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a single use, disposable device intended for medical purposes that is worn

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on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.

### ട. Indications for Use:

Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

List of Drugs tested concentration and breakthrough detection time in minutes. The maximum testing time is 240 minutes.

| Drug Tested | Concentration | Breakthrough<br>Detection Time<br>in Minutes |
|-----------------------------|----------------------|----------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 |
| Cisplatin | 1.0 mg/mL (1000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan®) | 20 mg/mL (20000 ppm) | > 240 |
| Dacarbazine (DTCI) | 10 mg/mL (10000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL (2000 ppm) | > 240 |
| Etoposide (Toposar®) | 20 mg/mL (20000 ppm) | > 240 |
| Fluorouracil | 50 mg/mL (50000 ppm) | > 240 |
| Paclitaxel (Taxol®) | 6.0 mg/mL (6000 ppm) | > 240 |
| Thiotepa | 10 mg/mL (10000 ppm) | 15.0 |

Warning: Do not use with Carmustine and Thiotepa.

| Please note that the following drugs have low permeation times: | | |
|-----------------------------------------------------------------|------------------------|--------------|
| Camustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 minutes |
| Thiotepa | 10.0 mg/mL (10000 ppm) | 15.0 minutes |

#### 6. Comparison to the 510(k) Cleared Devices (Predicate Devices):

### Table 1: Comparison to Predicate Device

| Characteristic | Predicate Device | Subject Device | Comparison<br>Analysis |
|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Manufacturer | Uweport LLC | Rubberex Alliance Sdn<br>Bhd | N/A |
| Device Name | Nitrile Exam Glove (tested<br>for use with Chemotherapy<br>Drugs) | Non-sterile Powder Free<br>Nitrile Examination Gloves<br>(tested for use with<br>Chemotherapy Drugs) | Similar |
| 510(k) Reference | K213227 | K221350 | N/A |
| Product Code | LZA, LZC, OPJ | LZA, LZC, OPJ | Same |
| Characteristic | Predicate Device | Subject Device | Comparison<br>Analysis |
| Indication for Use | Uweport Powder-Free<br>Nitrile Exam Gloves Tested<br>for Use with Chemotherapy<br>Drugs is a non-sterile,<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination. The Gloves<br>have been tested for use<br>with chemotherapy drugs<br>per ASTM D6978-05(2019)<br>Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs. | Non-sterile Powder Free<br>Nitrile Examination Gloves<br>(Tested for Use with<br>Chemotherapy Drugs) is a<br>non-sterile, disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination. The gloves<br>have been tested for use<br>with chemotherapy drugs<br>per ASTM D6978-<br>05(2019) Standard Practice<br>for Assessment of<br>Resistance of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs. | Similar |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Features | Ambidextrous<br>Textured fingertips<br>Beaded cuff<br>Straight fingers | Ambidextrous<br>Textured fingertips<br>Beaded cuff<br>Straight fingers | Same |
| Sizes | Small, Medium, Large,<br>Extra Large | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Different<br>(1) See Below |
| Dimension-Thickness | Complies with ASTM<br>D6319-19<br>Palm: 0.07S; 0.08M; 0.08L;<br>0.08XL all ± 0.03mm<br>Finger: 0.09 ± 0.03mm | Complies with ASTM<br>D6319-19<br>Palm: min 0.05mm<br>Finger: min 0.05mm | Different<br>See Below<br>(2) |
| Dimension-Width | Complies with ASTM<br>D6319-19<br>Small: 85 ± 5mm<br>Medium: 96 ± 5mm<br>Large: 108 ± 5mm<br>Extra Large: 115 ± 5mm | Complies with ASTM<br>D6319-19<br>Extra Small: 70 ± 10mm<br>Small: 80 ± 10mm<br>Medium: 95 ± 10mm<br>Large: 110 ± 10mm<br>Extra Large: 120 ± 10mm | Different<br>See Below<br>(3) |
| Dimension-Length | Complies with ASTM<br>D6319-19<br>Small: ≥ 220mm<br>Medium/Large/Extra Large:<br>≥ 240mm | Complies with ASTM<br>D6319-19<br>Extra Small/Small: ≥<br>220mm<br>Medium/Large/Extra<br>Large: ≥ 230mm | Different<br>See Below<br>(4) |
| Rx vs OTC | OTC | OTC | Same |
| Sterile vs Non-Sterile<br>Disposable vs Non-<br>Disposable | Non-Sterile<br>Disposable | Non-Sterile<br>Disposable | Same<br>Same |
| Biocompatibility<br>Cytotoxicity ISO<br>10993-5 | At 100% extraction the cell<br>viability was 17.1%. | Exhibited "Severe"<br>reactivity at 100%<br>concentration and no | Different<br>See Below<br>(5) |
| Characteristic | Predicate Device | Subject Device | Comparison<br>Analysis |
| Biocompatibility<br>Sensitization ISO<br>10993-10 | The test article passed both<br>extracts with a 0 score. | The test article passed both<br>extracts with a 0 score. | Same |
| Biocompatibility<br>Irritation ISO 10993-10 | The test article from both<br>extracts was categorized as<br>negligible under the test<br>conditions. | The test article from both<br>extracts was categorized as<br>negligible under the test<br>conditions. | Same |
| Biocompatibility<br>Acute Systemic<br>Toxicity ISO 10993-11:2017 | Under the conditions of the<br>study the test article extract<br>met the requirements of the<br>study; Body weight data and<br>animal appearance was<br>normal throughout the study. | Under the conditions of the<br>study the test article extract<br>met the requirements of the<br>study; Body weight data<br>and animal appearance was<br>normal throughout the<br>study. | Same |
| Single Use | Yes | Yes | Same |
| Physical Properties -<br>Tensile Strength | Complies with ASTM<br>D6319-19 at nominal<br>conditions ≥ 14MPa | Complies with ASTM<br>D6319-19 at nominal<br>conditions ≥ 14MPa | Same |
| Physical Properties -<br>Elongation | Complies with ASTM<br>D6319-19 at nominal<br>conditions; ≥ 500% | Complies with ASTM<br>D6319-19<br>Before aging: min 500%<br>After aging: min 400% | Different<br>(6) See Below |
| Freedom from Holes | Complies with ASTM<br>D5151-19; AQL = 2.5, 125<br>samples from batch of<br>35000, inspection level 1,<br>criterion ≤ 7<br>Zero nonconforming | Complies with ASTM<br>D5151-19; AQL = 2.5,<br>Inspection level G-1 | Similar |
| Residual Powder | ASTM D6124 Standard Test<br>Method for Residual Powder<br>on Medical Gloves; residual<br>powder 0.15; 0.18 and 0.19<br>mg/ glove | Complies with ASTM<br>D6124 Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves; residual powder ≤<br>2.0 mg/ glove | Similar |
| Chemotherapy<br>Permeation<br>ASTM D6978-<br>05(2019) Assessment<br>of Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | Carmustine (BCNU) 3.3<br>mg/mL (3300 ppm): 22.6<br>minutes | Carmustine (BCNU) 3.3<br>mg/mL (3300 ppm): 14.6<br>minutes | Similar |
| | Cisplatin 1.0 mg/mL (1000<br>ppm): > 240 minutes | Cisplatin 1.0 mg/mL (1000<br>ppm): > 240 minutes | Same |
| | Cyclophosphamide<br>(Cytoxan®) 20 mg/mL<br>(20000 ppm): > 240 minutes | Cyclophosphamide<br>(Cytoxan®) 20 mg/mL<br>(20000 ppm): > 240<br>minutes | Same |
| | Dacarbazine (DTIC) 10<br>mg/mL (10000 ppm): > 240<br>minutes | Dacarbazine (DTIC) 10<br>mg/mL (10000 ppm): ><br>240 minutes | Same |
| | Doxurubicin Hydrochloride<br>2.0 mg/mL (2000 ppm): ><br>240 minutes | Doxurubicin<br>Hydrochloride 2.0 mg/mL<br>(2000 ppm): > 240 minutes | Same |
| Characteristic | Predicate Device | Subject Device | Comparison<br>Analysis |
| | Etoposide (Toposar®) 20<br>mg/mL (20000 ppm): > 240<br>minutes | Etoposide (Toposar®) 20<br>mg/mL (20000 ppm): ><br>240 minutes | Same |
| | Fluorouracil 50 mg/mL<br>(50000 ppm): > 240 minutes | Fluorouracil 50 mg/mL<br>(50000 ppm): > 240<br>minutes | Same |
| | Paclitaxel (Taxol®) 6.0<br>mg/mL (6000 ppm): > 240<br>minutes | Paclitaxel (Taxol®) 6.0<br>mg/mL (6000 ppm): > 240<br>minutes | Same |
| | Thiotepa 10 mg/mL (10000<br>ppm): 46.8 minutes | Thiotepa 10 mg/mL<br>(10000 ppm): 15.0 minutes | Similar |

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# 1. Sizes

The subject device sizes ranges from Extra Small, Small, Medium, Large, Extra Large, whereas the predicate device size ranges from Small, Medium, Large, Extra Large. This does not introduce any new risk to the device.

# 2. Dimension-Thickness

The subject device dimension thickness Palm: measures at a min of 0.05mm and Finger: measures at a min of 0.05mm, whereas the predicate device Palm: measures at 0.07 Small; 0.08 Medium; 0.08 Large; 0.08 Extra Large all ± 0.03m and Finger measures at: 0.09 ± 0.03mm. These differences do not affect the performance nor introduce any new risk to the device.

# 3. Dimension-Width

The subject device which complies with ASTM D6319-19 measures for: Extra Small: 70 ± 10mm Small: 80 ± 10mm Medium: 95 ± 10mm Large: 110 ± 10mm Extra Large: 120 ± 10mm Whereas, the predicate device which complies with ASTM D6319-19 measures for: Small: 85 ± 5mm Medium: 96 ± 5mm Large: 108 ± 5mm Extra Large: 115 ± 5mm These differences do not affect the device's performance or safety and effectiveness.

# 4. Dimension-Length

The subject device which complies with ASTM D6319-19 measures for: Extra Small/Small: ≥ 220mm Medium/Large/Extra Large: ≥ 230mm Whereas, the predicate which complies with ASTM D6319-19 measures for: Small: ≥ 220mm Medium/Large/Extra Large: ≥ 240mm

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These dimensional differences does not introduce any new risk to the device. Nor does it affect the device's safety and effectiveness.

# 5. Biocompatibility- Cytotoxicity ISO 10993-5

The subject device exhibited "severe" reactivity at 100% concentration and no cytotoxic effect at 10% concentration. Whereas, for the predicate device, at 100% extraction the cell viability was 17.1%.. To demonstrate the safety of the materials the sponsor elected to perform a systemic toxicity study in which the device was found to be non-toxic.

# 6. Physical Properties - Elongation

The subject device which complies with ASTM D6319-19 was found to be Before aging: min 500% After aging: min 400% Whereas, the predicate device which complies with ASTM D6319-19 at nominal conditions was ≥ 500%

These differences do not affect the device's performance or safety and effectiveness.

### 7. Summary of Non-Clinical Tests Performed

Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) was tested and found in conformance with the following standards.

| Standard | Testing | Requirements | Results |
|---------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------|
| ASTM D6319-19 | Standard Specification<br>for Nitrile<br>Examination Gloves<br>for Medical<br>Application | Product dimension pass (between the<br>tolerance gaps) | Pass |
| | | Width: | |
| | | 70 mm (±10mm) - XS | |
| | | 80 mm (±10mm) - S | |
| | | 95 mm (±10mm) - M | |
| | | 110 mm (±10mm) - L | |
| | | 120 mm (±10mm) - XL | |
| | | Overall Length:<br>220 mm (Minimum) – S and XS<br>230 mm (Minimum) – M, L and<br>XL | |
| | | Thickness: (for all sizes)<br>Finger -0.05 mm (Minimum)<br>Palm -0.05mm (Minimum) | |
| ASTM D412-16 | Standards test method<br>for Vulcanized Rubber<br>and Thermoplastics<br>Elastomer - Tension | Physical properties:<br>Before Aging:<br>Tensile strength: min 14MPa<br>Elongation: min 500% | Pass |
| | | | |
| | | | |
| | | | |
| | | After Aging:<br>Tensile strength: min 14MPa | |

# Table 2: Summary Non-Clinical Tests

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| Standard | Testing | Requirements | Results |
|---------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| | | Elongation: min 400% | |
| ASTM D5151-19 | Standard Test Method<br>for detection of Holes<br>in Medical Gloves | Pass Inspection Level G1, AQL 2.5 | Pass |
| ASTM D6124-06 | Standard Test Method<br>for Residual Powder<br>on Medical Gloves | Residual powder meets specification<br><2.0mg/glove | Pass |
| ASTM D6978-05 | Standard Practice for<br>Assessment of<br>Resistance of Medical<br>Gloves to Permeation<br>by Chemotherapy<br>Drugs | An assessment is made based on the<br>permeation (breakthrough) of nine<br>chemotherapy drugs through the<br>glove material over a certain period<br>of time | See Table 1 above |
| ISO 10993-5 | Biological Evaluation<br>on Medical Devices-<br>Part 5: Test for In<br>Vitro Cytotoxicity | Pass in vitro cytotoxicity | Exhibited "Severe"<br>reactivity at 100%<br>concentration and no<br>cytotoxic effect at<br>10% concentration. |
| ISO 10993-10 | Biological evaluation<br>on medical device Part<br>10: Test for Irritation<br>and Skin Sensitization | No irritating and sensitizing | Under the condition<br>of study not an<br>irritant or a<br>sensitizer. |
| ISO 10993-11 | Biological Evaluation<br>of Medical Devices -<br>Part 11: Test for<br>Systemic Toxicity | No systemic toxic | Under the condition<br>of the test, not a<br>systemic toxicity. |

The following National and International Standards were utilized for testing the subject device:

| ASTM D6319-19 | Standard Specification for Nitrile Examination Gloves<br>for Medical Application |
|---------------|---------------------------------------------------------------------------------------------------------|
| ASTM D412-16 | Standard Test Methods for Volcanized Rubber and<br>Thermoplastic Elastomers - Tension |
| ASTM D5151-19 | Standard Test Method for detection of Holes in Medical<br>Gloves |
| ASTM D6124-06 | Standard Test Method for Residual Powder on Medical<br>Gloves |
| ASTM D6978-05 | Standard Practice for Assessment of Resistance of<br>Medical Gloves to Permeation by Chemotherapy Drugs |
| ISO 10993-5 | Biological Evaluation on Medical Devices- Part 5: Test<br>for In Vitro Cytotoxicity |
| ISO 10993-10 | Biological Evaluation on Medical Devices- Part 10: Test<br>for Irritation and Skin Sensitization |
| ISO 10993-11 | Biological Evaluation of Medical Devices – Part 11:Test<br>for Systemic Toxicity |

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### Summary of Clinical Testing: 8.

Clinical Testing is not required for the subject gloves.

### 9. Conclusions:

The conclusion drawn from the non-clinical tests demonstrates that the subject device, Non-sterile Powder Free Nitrile Examination Glove (tested for use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K213227.