Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)

K222225 · Hartalega NGC Sdn. Bhd. · LZA · Nov 11, 2022 · General Hospital

Device Facts

• Record ID: K222225
• Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
• Applicant: Hartalega NGC Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

Device Story

Disposable, non-sterile, blue nitrile examination glove; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05. Used in clinical settings; provides barrier protection. Output is physical barrier; informs clinical decision-making by ensuring safety during chemotherapy drug handling. Benefits patient and clinician by reducing exposure to hazardous substances.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder), ASTM D6319 (dimensions/tensile properties), and ASTM D6978-05 (chemotherapy permeation). Biocompatibility confirmed via ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Material: Nitrile. Form factor: Disposable, powder-free, ambidextrous, blue. Standards: ASTM D6319-19 (dimensions/physical properties), ASTM D5151-19 (integrity), ASTM D6124-06 (powder residual), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: ISO 10993-10, ISO 10993-11. Non-sterile. No software or energy source.

Indications for Use

Indicated for use as a non-sterile, disposable medical examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for resistance to permeation by chemotherapy drugs per ASTM D6978-05 (2019).

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

• Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) (K151997)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

November 11, 2022

Hartalega NGC Sdn. Bhd. Nurul Kong General Manager-Ouality Assurance No. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, Selangor Darul Ehsan 43900 Malaysia

Re: K222225

Trade/Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: August 9, 2022 Received: August 17, 2022

Dear Nurul Kong:

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.

{1}------------------------------------------------

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 -S

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 Ouality Center for Devices and Radiological Health

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K22225

#### Device Name

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)

#### Indications for Use (Describe)

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

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

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---------------------------------------|------------------------------------------------|
| Carmustine (3.3 mg/ml) | 10.2 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Bleomycin Sulfate, 15.0 mg/ml | >240 |
| Bortezomib, 1.0 mg/ml | >240 |
| Busulfan, 6.0 mg/ml | >240 |
| Carboplatin, 10.0 mg/ml | >240 |
| Chloroquine, 50.0 mg/ml | >240 |
| Cyclosporin A, 100.0 mg/ml | >240 |
| Cytarabine, 100.0 mg/ml | >240 |
| Daunorubicin, 5.0 mg/ml | >240 |
| Docetaxel, 10.0 mg/ml | >240 |
| Epirubicin, 2.0 mg/ml | >240 |
| Fludarabine, 25.0 mg/ml | >240 |
| Gemcitabine, 38.0 mg/ml | >240 |
| Idarubicin, 1.0 mg/ml | >240 |
| Ifosfamide, 50.0 mg/ml | >240 |
| Irinotecan, 20.0 mg/ml | >240 |
| Mechlorethamine HCI, 1.0 mg/ml | >240 |
| Melphalan, 5.0 mg/ml | >240 |
| Mitoxantrone, 2.0 mg/ml | >240 |
| Oxaliplatin, 2.0 mg/ml | >240 |
| Paraplatin, 10.0 mg/ml | >240 |
| Retrovir, 10.0 mg/ml | >240 |
| Rituximab, 10.0 mg/ml | >240 |
| Topotecan, 1.0 mg/ml | >240 |

{3}------------------------------------------------

| Trisenox, 1.0 mg/ml |
|---------------------|
|---------------------|

> 240

Caution: Testing showed an average breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa. Warning: Do not use with Carmustine and Thiotepa

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(k) SUMMARY

# K222225

# NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)

(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)

#### 1. SUBMISSION APPLICANT

1

| Date Prepared | : | November 10, 2022 |
|--------------------------------------|---|----------------------------------------------------------------------------------------------------|
| Name | : | Hartalega NGC Sdn. Bhd. |
| Address | : | No. 1, Persiaran Tanjung,<br>Kawasan Perindustrian Tanjung,<br>43900 Sepang, Selangor,<br>Malaysia |
| Establishment Registration<br>Number | : | 3011200663 |

# SUBMISSION CORRESPONDENT AND/OR PREPARER

| Contact Name : | Nurul Aisyah Kong |
|-----------------|-------------------------------------|
| Contact Title : | General Manager – Quality Assurance |
| Phone Number : | (603) 3280 3888 |
| Fax Number : | (603) 3271 0135 |
| Contact Email : | [e-mail] |

# 2. DEVICE IDENTIFICATION

| Common Name of the Device | : | Examination Glove |
|-------------------------------|---|-------------------------------------------------------------------------------------|
| Trade Name (Proprietary Name) | : | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) |
| Device Class | : | 1 |
| Product Code | : | LZA, LZC, OPJ |
| Regulation Number | : | 21 CFR 880.6250 |

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

# 3. PREDICATE DEVICE INFORMATION

| 510(k)<br>Number | Tradename | Product<br>Code |
|-------------------------------|------------------------------------------------------------------------------------------------------|-----------------|
| K151997 | Nitrile Powder Free Examination Glove Tested for Use with<br>Chemotherapy Drugs - Violet Blue (VBLU) | LZA |
| Regulation Name | Patient Examination Glove | |
| Trade Name (Proprietary Name) | Nitrile Powder Free Examination Glove Tested for Use with<br>Chemotherapy Drugs - Violet Blue (VBLU) | |
| Device Class | 1 | |
| Product Code | LZA | |
| Regulation Number | 21 CFR 880.6250 | |

#### 4. DESCRIPTION OF THE DEVICE:

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a disposable singleuse, non-sterile, blue-colored and powder-free examination glove made from nitrile latex.

#### 5. INDICATIONS FOR USE:

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

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

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in<br>Minutes |
|---------------------------------------|---------------------------------------------------|
| Carmustine (3.3 mg/ml) | 10.2 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |

Hartalega NGC Sdn. Bhd.

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

| Thiotepa (10.0 mg/ml) | 30.2 |
|---------------------------------|-------|
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Bleomycin Sulfate, 15.0 mg/ml | > 240 |
| Bortezomib, 1.0 mg/ml | > 240 |
| Busulfan, 6.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 |
| Chloroquine, 50.0 mg/ml | > 240 |
| Cyclosporin A, 100.0 mg/ml | > 240 |
| Cytarabine, 100.0 mg/ml | > 240 |
| Daunorubicin, 5.0 mg/ml | > 240 |
| Docetaxel, 10.0 mg/ml | > 240 |
| Epirubicin, 2.0 mg/ml | > 240 |
| Fludarabine, 25.0 mg/ml | > 240 |
| Gemcitabine, 38.0 mg/ml | > 240 |
| Idarubicin, 1.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Irinotecan, 20.0 mg/ml | > 240 |
| Mechlorethamine HCl, 1.0 mg/ml | > 240 |
| Melphalan, 5.0 mg/ml | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 |
| Oxaliplatin, 2.0 mg/ml | > 240 |
| Paraplatin, 10.0 mg/ml | > 240 |
| Retrovir, 10.0 mg/ml | > 240 |
| Rituximab, 10.0 mg/ml | > 240 |
| Topotecan, 1.0 mg/ml | > 240 |
| Trisenox, 1.0 mg/ml | > 240 |

Caution: Testing showed an average breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.

Warning: Do not use with Carmustine and Thiotepa

# 6. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:

| Characteristics<br>and Parameters | Subject Device | Predicate Device (K151997) | Discussion |
|-----------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Nitrile Powder Free Examination Glove<br>Tested for Use with Chemotherapy<br>Drugs (Blue) | Nitrile Powder Free Examination Gloves<br>Tested for Use with Chemotherapy Drugs<br>– Violet Blue (VBLU) | - |
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega NGC Sdn. Bhd. | Same |
| Product Code | LZA, LZC, OPJ | LZA | Similar |
| Classification | 1 | 1 | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |

{7}------------------------------------------------

| Regulation Name | Patient Examination Glove | Patient Examination Glove | Same |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indications for Use | A non-sterile disposable device intended<br>for medical purpose that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. It is also tested to be used<br>against Chemotherapy Drugs.<br>The gloves were tested for use with<br>chemotherapy drugs as per ASTM<br>D6978-05 (Reapproved 2019) Standard<br>Practice for Assessment of Resistance of<br>Medical Gloves to Permeation by<br>Chemotherapy Drugs. | A non-sterile disposable device intended<br>for medical purpose that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. It is also tested to be used<br>against Chemotherapy Drugs.<br>The gloves were tested for use with<br>chemotherapy drugs as per ASTM D6978-<br>05 (Reapproved 2019) Standard Practice<br>for Assessment of Resistance of Medical<br>Gloves to Permeation by Chemotherapy<br>Drugs. | Similar |
| | Chemotherapy Drug<br>and Concentration | Chemotherapy Drug<br>and Concentration | |
| | Minimum Breakthrough<br>Detection Time<br>in Minutes | Minimum Breakthrough<br>Detection Time<br>in Minutes | |
| | Carmustine, 3.3 mg/ml 10.2 | Carmustine, 3.3 mg/ml 10.2 | |
| | Cisplatin, 1.0 mg/ml > 240 | Cisplatin, 1.0 mg/ml > 240 | |
| | Cyclophosphamide<br>(Cytoxan), 20.0 mg/ml > 240 | Cyclophosphamide<br>(Cytoxan), 20.0 mg/ml > 240 | |
| | Dacarbazine, 10.0 mg/ml > 240 | Dacarbazine, 10.0 mg/ml > 240 | |
| | Doxorubicin Hydrochloride,<br>2.0 mg/ml > 240 | Doxorubicin Hydrochloride,<br>2.0 mg/ml > 240 | |
| | Etoposide (Toposar), 20.0<br>mg/ml > 240 | Etoposide (Toposar), 20.0<br>mg/ml > 240 | |
| | Fluorouracil, 50.0 mg/ml > 240 | Fluorouracil, 50.0 mg/ml > 240 | |
| | Methotrexate, 25.0 mg/ml > 240 | Methotrexate, 25.0 mg/ml > 240 | |
| | Mitomycin C, 0.5 mg/ml > 240 | Mitomycin C, 0.5 mg/ml > 240 | |
| | Paclitaxel (Taxol), 6.0 mg/ml > 240 | Paclitaxel (Taxol), 6.0 mg/ml > 240 | |
| | Thiotepa, 10.0 mg/ml 30.2 | Thiotepa, 10.0 mg/ml 30.2 | |
| | Vincristine Sulfate, 1.0 mg/ml > 240 | Vincristine Sulfate, 1.0 mg/ml > 240 | |
| | Bleomycin Sulfate, 15.0 mg/ml > 240 | Caution: Testing showed an average<br>breakthrough time of 10.2 minutes with<br>Carmustine and 30.2 minutes with<br>Thiotepa. | |
| | Bortezomib, 1.0 mg/ml > 240 | Warning: Do not use with Carmustine and<br>Thiotepa | |
| | Busulfan, 6.0 mg/ml > 240 | | |
| | Carboplatin, 10.0 mg/ml > 240 | | |
| | Chloroquine, 50.0 mg/ml > 240 | | |
| | Cyclosporin A, 100.0 mg/ml > 240 | | |
| | Cytarabine, 100.0 mg/ml > 240 | | |
| | Daunorubicin, 5.0 mg/ml > 240 | | |
| | Docetaxel, 10.0 mg/ml > 240 | | |
| | Epirubicin, 2.0 mg/ml > 240 | | |
| | Fludarabine, 25.0 mg/ml > 240 | | |
| | Gemcitabine, 38.0 mg/ml > 240 | | |
| | Idarubicin, 1.0 mg/ml > 240 | | |
| | Ifosfamide, 50.0 mg/ml > 240 | | |
| | Irinotecan, 20.0 mg/ml > 240 | | |
| | Mechlorethamine HCl, 1.0 mg/ml > 240 | | |

{8}------------------------------------------------

| | Melphalan, 5.0 mg/ml > 240<br>Mitoxantrone, 2.0 mg/ml > 240<br>Oxaliplatin, 2.0 mg/ml > 240<br>Paraplatin, 10.0 mg/ml > 240<br>Retrovir, 10.0 mg/ml > 240<br>Rituximab, 10.0 mg/ml > 240<br>Topotecan, 1.0 mg/ml > 240<br>Trisenox, 1.0 mg/ml > 240<br><br>Caution: Testing showed an average<br>breakthrough time of 10.2 minutes with<br>Carmustine and 30.2 minutes with<br>Thiotepa.<br><br>Warning: Do not use with Carmustine<br>and Thiotepa | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Type of use | Over the counter use | Over the counter use | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design | • Single Use<br>• Non-sterile<br>• Powder-Free<br>• Ambidextrous | • Single Use<br>• Non-sterile<br>• Powder-Free<br>• Ambidextrous | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Freedom from<br>holes | Meets ASTM D5151-19 and ASTM D6319-<br>19: AQL 1.5 | Meets ASTM D5151-19 and ASTM D6319-<br>19: AQL 1.5 | Same |
| Length | Meets ASTM D6319-19:<br>$\geq$ 230 mm | Meets ASTM D6319-19:<br>$\geq$ 240 mm | Same |
| Dimensions | Meets ASTM D6319-19: XS - 70 ± 10 mm<br>S - 80 ± 10 mm<br>M - 95 ± 10 mm<br>L - 110 ± 10 mm<br>XL - 120 ± 10 mm | Meets ASTM D6319-19: XS - 70 ± 10 mm<br>S - 80 ± 10 mm<br>M - 95 ± 10 mm<br>L - 110 ± 10 mm<br>XL - 120 ± 10 mm | Same |
| Thickness | Meets ASTM D6319-19:<br>Palm Thickness: Min 0.05 mm Finger<br>Thickness: Min 0.05 mm | Meets ASTM D6319-19:<br>Palm Thickness: 0.08 ± 0.01 mm Finger<br>Thickness: $\geq$ 0.10 mm | Same |
| Physical<br>Properties | Meets ASTM D6319-19:<br>Tensile Strength Before Aging: $\geq$ 14 MPa<br>Tensile Strength After Aging: $\geq$ 14 MPa<br>Ultimate Elongation Before Aging: $\geq$ 500 %<br>Ultimate Elongation After Aging: $\geq$ 400 % | Meets ASTM D6319-19:<br>Tensile Strength Before Aging: $\geq$ 14 MPa<br>Tensile Strength After Aging: $\geq$ 14 MPa<br>Ultimate Elongation Before Aging: $\geq$ 500 %<br>Ultimate Elongation After Aging: $\geq$ 400 % | Same |
| Powder residual | Meets ASTM D6319-19 & ASTM D6124-<br>06 (2017):<br>Residual Powder: $\leq$ 2 mg per glove | Meets ASTM D6319-19 & ASTM D6124-06<br>(2017):<br>Residual Powder: $\leq$ 2 mg per glove | Same |
| Primary Skin<br>Irritation ISO<br>10993-10 | Under the conditions of the study, the<br>device is not an irritant | Under the conditions of the study, the<br>device not an irritant | Same |
| Dermal | Under the conditions of the study, the | Under the conditions of the study, the | Same |
| Sensitization<br>ISO 10993-10 | device is not a sensitizer | device not a sensitizer | |
| Acute Systemic<br>Toxicity Test ISO<br>10993-11 (2017) | Under the conditions of this study, the<br>device showed no evidence of acute<br>systemic toxicity | Not performed | Different |

{9}------------------------------------------------

# 7. SUMMARY OF NON-CLINICAL TESTING:

Non-clinical tests were conducted to verify that the subject device meets all design specifications.

| Test | Purpose | Criteria | Result |
|--------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Standard Test Method for<br>Detection of Holes in Medical<br>Gloves<br>ASTM D5151-19 | To demonstrate glove integrity | Freedom from holes<br>AQL 1.5% | Pass |
| Standard Test Method for Residual<br>Powder on Medical Gloves<br>ASTM D6124-06(R17) | To demonstrate the gloves are<br>'powder free' | Average less than 2<br>mg/glove | Pass |
| Dimensional Conformance<br>ASTM D6319 | To demonstrate appropriate<br>dimensions for labeled sizes | Conforms to ASTM D6319<br>width, thickness, and<br>length requirements for<br>XS, S, M, L, and XL<br>AQL 4% | Pass |
| Tensile Performance<br>ASTM D6319 | To demonstrate adequate tensile<br>properties | Conforms to ASTM D6319<br>tensile strength of at least<br>14MPa and ultimate<br>elongation of at least<br>500% requirements prior<br>to aging, and tensile<br>strength of at least<br>14MPa and ultimate<br>strength of at least 400%<br>after accelerated aging<br>AQL 4% | Pass |
| Biocompatibility: Skin Irritation<br>ISO 10993-10 | To demonstrate low potential for<br>skin irritation | Under the conditions of<br>the study, not an irritant. | Pass |
| Biocompatibility: Skin Sensitization<br>ISO 10993-10 | To demonstrate low potential for<br>skin sensitization | Under the conditions of<br>the study, not a sensitizer | Pass |
| Biocompatibility:<br>Acute Toxicity<br>ISO 10993-11 | To demonstrate low acute<br>toxicity | Under the conditions of<br>the study, no acute<br>toxicity | Pass |

# CLINICAL PERFORMANCE DATA:

Not applicable. No clinical testing was performed in support of this submission.

#### CONCLUSION:

The conclusions drawn from the non-clinical performance data demonstrate that, the subject device, Nitrile

Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue), is as safe, as effective and performs as well as or better than the legally marketed predicate device K151997.

Hartalega NGC Sdn. Bhd.