Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)

K212408 · Pt. Maja Agung Latexindo · LZA · May 18, 2022 · General Hospital

Device Facts

• Record ID: K212408
• Device Name: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
• Applicant: Pt. Maja Agung Latexindo
• Product Code: LZA · General Hospital
• Decision Date: May 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate.

Device Story

Non-sterile, ambidextrous, powder-free nitrile examination gloves; intended for medical use to prevent cross-contamination between patient and examiner. Manufactured from nitrile synthetic rubber with surface treatment for easy donning. Tested per ASTM D6978-05(2019) for permeation resistance against various chemotherapy drugs, simulated gastric acid, and fentanyl citrate. Used in clinical settings by healthcare professionals. Provides a barrier against biological contaminants and specific chemical agents. Benefits include protection for the examiner during patient examination and handling of hazardous substances, though specific drugs (Carmustine, Thiotepa) show limited breakthrough times and are not recommended for use.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, 10, 11), physical properties (tensile strength, elongation), freedom from pinholes (ASTM D5151-06), residual powder (ASTM D6124-06), and chemical permeation resistance (ASTM D6978-05).

Technological Characteristics

Nitrile synthetic rubber; powder-free; ambidextrous; non-sterile. Complies with ASTM D6319-19 (dimensions/physical properties), ASTM D5151-06 (pinholes), and ASTM D6124-06 (residual powder). Biocompatibility per ISO 10993-5, 10, 11. Permeation testing per ASTM D6978-05.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for use with specific chemotherapy drugs, simulated gastric acid, and fentanyl citrate. Contraindicated for use with Carmustine (BCNU) 3.3 mg/ml and Thiotepa (10 mg/ml).

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

• EMG Blue Nitrile Examination Gloves Powder free with tested for use with Chemotherapy Drugs (K171339)

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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 18, 2022

Pt. Maja Agung Latexindo % Jeni Chuason Official Correspondent Shamrock Marketing Co., Inc. 5445 Daniels Street Chino, California 91710

Re: K212408

Trade/Device Name: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, 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, ODO Dated: April 20, 2022 Received: April 25, 2022

Dear Jeni Chuason:

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 medical devices and radiation-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 Oian, M.D., Ph.D. Acting 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

Enclosure

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### Indications for Use

510(k) Number (if known) K212408

#### Device Name

Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate).

#### Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate.

| Chemotherapy Drug and Permeation | |
|-------------------------------------------------------------|----------------------------------------|
| The following chemicals have been tested with these gloves: | |
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
| Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) | > 240 min. |
| Carmustine (BCNU), 3.3 mg/ml (3,300ppm) | 58.3 min (Not recommended for use) |
| Cisplatin, 1.0 mg/ml (1,000ppm) | > 240 min |
| Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine, 10.0mg/ml (10,000ppm) | > 240 min |
| Docetaxel, 10mg/ml (10,000ppm) | > 240 min |
| Doxorubicin HCI, 2.0mg/ml (2,000ppm) | > 240 min |
| Etoposide, 20.0mg/ml (20,000ppm) | > 240 min |
| Fluorouracil, 50.0mg/ml (50,000ppm) | > 240 min |
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate, 25mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min |
| ThioTepa, 10.0mg/ml (10,000ppm) | 119 min (Not recommended for use) |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min |
| Simulated Gastric Acid | > 240 min |
| Fentanyl Citrate Injection 100.0 mg/2ml | > 240 min |

WARNING: Do not use with Carmustine (BCNU) 3.3 mg/ml and Thiotepa (10mg/ml).

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for PT. MAJAAGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized "Ma" in red on the left, with blue horizontal lines behind it. To the right of the "Ma" is the company name in green, with the words "Manufacturer of Latex Gloves" in smaller black font below.

# 510(k) Summary K212408

#### 1) Submitter

| Name of applicant: | Sivaprakash.S |
|------------------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | PT. MAJA AGUNG LATEXINDO<br>Jl. Utama No. 98, Pujimulyo, Sunggal 20352 Deli Serdang<br>North Sumatera - Indonesia |
| Phone No.: | 62-61-8459170 |
| Fax No.: | 62-61-8459180 |
| Email: | [e-mail] |
| Contact person in USA: | Jeni Chuason |
| Phone No.: | [phone] |
| Fax No: | [phone] |
| Email: | [e-mail] |

#### Summary preparation Date: July 19, 2021 Type of submission: Traditional

#### 2) Device Information:

#### Device Name /

| Device Name / Trade Name: | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Patient Exam Glove, Medical Gloves with Chemotherapy / Simulated Gastric Acid / Fentanyl Citrate Labeling Claims |
| Classification: | Class I, Non-Sterile |
| Classification panel: | General Hospital |
| Regulation Number: | 21 CFR 880.6250 |
| Common Name: | Patient Examination Glove, Specialty |
| Product Code: | LZA, LZC, OPJ, QDO |

#### 3) Identification of the Legally Marketed Devices That Equivalency is Claimed:

Primary Predicate: Device name: EMG Blue Nitrile Examination Gloves Powder free with tested for use with Chemotherapy Drugs Company: ECO Medi Glove Sdn. Bhd 510(k): K171339 Regulatory Class I Product Code: LZA, LZC

#### 4) Device Description:

The Powder Free Nitrile Examination Gloves, Blue Color, Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate are non-sterile, single use, disposable gloves intended for

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Image /page/5/Picture/0 description: The image contains a logo for PT. MAJAAGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized red graphic on the left, with the company name in green text on the right. The words "Manufacturer of Latex Gloves" are printed in a smaller font below the company name.

medical purposes to be worn on the hands of examiners to prevent contamination between patient and examiner. The gloves are ambidextrous, i.e. can be worn on right hand or left hand.

The gloves are manufactured from nitrile synthetic rubber. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate per ASTM D6978-05(2019).

| 4.1. Dimension and Thickness of the Gloves | | | | | | |
|--------------------------------------------|-------------|-------------|-------------|--------------|--------------|--------------|
| Dimension | Size | | | | | |
| Overall Length (mm) min. | XS | S | M | L | XL | XXL |
| | 220 | 220 | 230 | 230 | 230 | 230 |
| Palm Width (mm) min. | $70 \pm 10$ | $80 \pm 10$ | $95 \pm 10$ | $110 \pm 10$ | $120 \pm 10$ | $130 \pm 10$ |
| Thickness (mm) min. | | | | | | |
| Cuff | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 |
| Palm | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 |
| Fingertip | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 |

#### Gloves Specification

#### 4.2. Physical Properties and Freedom of Pinholes

| Measurement | Before Aging | After Aging at<br>70°C for 168 hours |
|-----------------------------|---------------------------------|--------------------------------------|
| Tensile Strength (mpa) | 14 min. | 14 min. |
| Ultimate Elongation (%) | 500 min. | 400 min. |
| Freedom from pinholes Level | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>Inspection Level G-1 |

#### 5) Indications for Use:

Powder Free Nitrile Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Test Results follows:

| Drugs Name | Concentration Tested | Breakthrough Detection<br>Time<br>(Minutes) |
|--------------------------|-----------------------|---------------------------------------------|
| Carboplatin (Paraplatin) | 10 mg/ml (10,000 ppm) | > 240 min |

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Image /page/6/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of two parts: a stylized "Ma" in red and blue stripes on the left, and the company name in green on the right. The words "Manufacturer of Latex Gloves" are written in a smaller font below the company name.

| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 58.3 min |
|------------------------------|-----------------------|-----------|
| Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 min |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 min |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 min |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | > 240 min |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 min |
| Fluorouracil | 50 mg/ml (50,000 ppm) | > 240 min |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 min |
| ThioTepa | 10 mg/ml (10,000 ppm) | 119 min |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 min |
| Simulated Gastric Acid Fluid | | > 240 min |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min |

Please note that the following drugs that have low permeation time are:

Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) 58.3 min.

ThioTepa, 10 mg/ml (10,000 ppm) 119.0 min

Caution: Testing showed an average of breakthrough time 58.3-67.3 for Carmustine and 119 for ThioTepa

#### 6) Comparison of the Technological Characteristics of the Device:

| Device<br>Characteristic | Predicate Device | Proposed Device | Comparison<br>Analysis |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | Eco Medi Glove Sdn, Bhd | PT. MAJA AGUNG<br>LATEXINDO | N/A |
| Product code | LZA, LZC | LZA, LZC, OPJ, QDO | N/A |
| Trade Name | EMG Blue Nitrile Patient<br>Examination Gloves Powder<br>Free Tested for Use with<br>Chemotherapy Drugs | Powder Free Nitrile<br>Examination Gloves (Tested for<br>Use with Chemotherapy Drugs,<br>Simulated Gastric Acid, and<br>Fentanyl Citrate) | N/A |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| 510(K) | K171339 | K212408 | Same |
| Intended use | A powder free patient | A patient examination glove is a | Similar |
| | examination glove is a<br>disposable device intended for<br>medical purpose that is worn on<br>examiner's hand to prevent<br>contamination between patient<br>and examiner. | disposable device intended for<br>medical purpose that is worn on<br>examiner's hand to prevent<br>contamination between patient<br>and examiner.<br>These gloves were tested for use<br>with Chemotherapy Drugs,<br>Simulated Gastric Acid, and<br>Fentanyl Citrate as per ASTM<br>D6978-05(2019) Standard<br>Practice for Assessment of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs. | |
| Rx or OTC | Over the counter | Over the counter | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Single use | Single use | Same |
| Contact Duration | N/A | Limited ≤ 24 hours | Different |
| Dimensions | Meets ASTM D6319-10<br>Size: Medium<br>Palm Width: 98 mm<br>Length: 247 mm<br>Finger Thickness: 0.08 mm<br>Palm Thickness: 0.05 mm | Complies with:<br>ASTM D6319-10<br>Size: XS, S, M, L, XL, XXL<br>Palm Width: 95 ± 10 (size M)<br>Length: min 230 mm<br>Finger Thickness: 0.13 mm<br>Palm Thickness: min 0.12 mm | Similar |
| Physical Properties | Tensile strength (Mpa):<br>Before Aging: 25.45 Mpa<br>After Accelerated aging: 26.33 Mpa<br>Ultimate Elongation(%):<br>Before Aging: 600%<br>After Aging: 550%<br>Meets ASTM D6319-10 | Tensile strength (Mpa):<br>Before Aging: min 14 Mpa<br>After Accelerated aging: 14 Mpa<br>Ultimate Elongation(%):<br>Before Aging: min 500%<br>After Aging: min 400%<br>Meets ASTM D6319-10 | Similar |
| Freedom from<br>pinholes | AQL 2.5<br>Meets ASTM D5151-06 | AQL 2.5<br>Meets ASTM D5151-06 | Same |
| Residual Powder | Complies with ASTM D6124-06<br>Average (size M):<br>0.17 mg/glove | Complies with ASTM D6124-06<br>Average (size M):<br>0.35mg/glove | Similar |
| Biocompatibility:<br>ISO 10993-10:<br>Skin Irritation Test | Not a skin irritant | Not a skin irritant | Same |
| Skin Sensitizer<br>ISO 10993-11: | Not a skin sensitizer | Not a skin sensitizer | |
| Systemic Toxicity | Not available | Not Toxic | Different |
| Tested<br>Chemotherapy<br>Drugs and<br>breakthrough<br>detection time in<br>minutes | | | |
| | Carboplatin (Paraplatin)<br>10mg/ml (10,000 ppm)<br>>240 min | Carboplatin (Paraplatin)<br>10mg/ml (10,000 ppm)<br>>240 min | Same |
| | Carmustine (BCNU) 3.3 mg/ml<br>(3300 ppm)<br>24 mins | Carmustine (BCNU) 3.3 mg/ml<br>(3300 ppm)<br>58.3 mins | Similar |
| | Cisplatin 1mg/ml (1000 ppm)<br>>240 min | Cisplatin 1mg/ml (1000 ppm)<br>>240 min | Same |
| | Cyclophosphamide (Cytoxan)<br>20mg/ml (20000 ppm)<br>>240 min | Cyclophosphamide (Cytoxan)<br>20mg/ml (20000 ppm)<br>>240 min | Same |
| | Dacarbazine 10mg/ml (10000 ppm) >240 min | Dacarbazine 10mg/ml (10000 ppm) >240 min | Same |
| | | Docetaxel 10mg/ml (10000 ppm) >240 min | Different |
| | Doxorubicin HCl 2mg/ml (2000 ppm) >240 min | Doxorubicin HCl 2mg/ml (2000 ppm) >240 min | Same |
| | Etoposide 20mg/ml (2000 ppm)<br>>240 min | Etoposide 20mg/ml (2000 ppm)<br>>240 min | Same |
| | Fluorouracil 50mg/ml (50000 ppm) >240 min | Fluorouracil 50mg/ml (50000 ppm) >240 min | Same |
| | Ifosfamide 50mg/ml (50000 ppm) >240 min | Ifosfamide 50mg/ml (50000 ppm) >240 min | Same |
| | Methotrexate 25mg/ml (25000 ppm) >240 min | Methotrexate 25mg/ml (25000 ppm) >240 min | Same |
| | Mitomycin C 0.5mg/ml (500 ppm) >240 min | Mitomycin C 0.5mg/ml (500 ppm) >240 min | Same |
| | Mitoxantrone 2mg/ml<br>>240 min | | Different |
| | Paclitaxel 6mg/ml (6000 ppm)<br>>240 min | Paclitaxel 6mg/ml (6000 ppm)<br>>240 min | Same |
| | ThioTepa 10mg/ml (10000 ppm)<br>56.9 mins | ThioTepa 10mg/ml (10000 ppm)<br>119 mins | Similar |
| | Vincristine Sulfate 1mg/ml<br>(1000 ppm)<br>>240 min | Vincristine Sulfate 1mg/ml<br>(1000 ppm)<br>>240 min | Same |
| Simulated<br>Gastric<br>Acid | | Simulated Gastric Acid Fluid<br>>240 min | Different |
| Fentanyl Testing | | Fentanyl Citrate Injection<br>100mcg/2mL<br>>240 min | Different |

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Image /page/7/Picture/0 description: The image contains the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized "Ma" in red and blue on the left. To the right of the logo is the company name in green, with "Manufacturer of Latex Gloves" in a smaller font below.

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Image /page/8/Picture/0 description: The image is a company logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized "Ma" in red on the left, with blue horizontal lines behind it. To the right of the "Ma" is the company name in green, with "PT. MAJA AGUNG" on top and "LATEXINDO" below it. Underneath the company name is the text "Manufacturer of Latex Gloves" in a smaller font.

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Image /page/9/Picture/0 description: The image shows the logo for PT. MAJAAGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of two parts: a stylized red "Ma" on a blue striped background, and the company name in green, with "PT. MAJAAGUNG" on top and "LATEXINDO" below. Underneath the company name, it says "Manufacturer of Latex Gloves" in a smaller, gray font.

# Summary of the technological characteristics of the proposed device in comparison to the predicate device.

Based on the comparison of technological characteristics between proposed device and the predicate device, the devices were found to be similar in terms of indications for use, dimension, physical properties, freedom from pinholes, and residual powder and met with ASTM D5151-06 and D6319-19 standard. Both proposed and predicate devices also were tested for use with chemotherapy drugs per ASTM D6978-05 standard, but the proposed device also added fentanyl and simulated gastric acid testing that made the difference. Lastly, both performed biocompatibility testing and found with the similar result to be nonirritant, non-sensitizer, nor toxic.

### 7) Substantial Equivalent Based on Assessment of Non-Clinical Performance Data.

Summary of Non-Clinical Testing

#### a. Biocompatibility Testing

| Name of test / citation | Purpose | Acceptance<br>Criteria | Results |
|-----------------------------------------------------------------------|----------------------------------|------------------------|----------------------------------------------|
| ISO 10993-10: Biological<br>Evaluation of Medical Devices,<br>Part 10 | Irritation Testing | Pass/Fail | Pass<br>Not a primary skin<br>irritant |
| ISO 10993-10: Biological<br>Evaluation of Medical Devices,<br>Part 10 | Sensitization Testing | Pass/Fail | Pass<br>Not a primary skin<br>sensitizer |
| ISO 10993-5: Biological<br>Evaluation of Medical Devices,<br>Part 5 | In Vitro Cytotoxicity<br>Testing | Pass/Fail | Failed<br>Exhibit cytotoxicity<br>reactivity |
| ISO 10993-11: Biological<br>Evaluation of Medical Devices,<br>Part 11 | Systemic Toxicity<br>Testing | Pass/Fail | Pass<br>Not toxic |

Table below summarize the biocompatibility testing result

#### b. Performance Test Data - Summary of Non-Clinical Testing

The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test method, standards, and specification:

- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application ●
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06, Standard Tested Method for Residual Powder on medical Gloves ●

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Image /page/10/Picture/0 description: The image is a logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features the company's name in green, with the words "PT. MAJA AGUNG" on top of "LATEXINDO". Below the name is the text "Manufacturer of Latex Gloves" in a smaller font. To the left of the company name is a red and blue graphic.

# Physical Dimensions

| Purpose<br>Dimension | Test Method<br>ASTM D6319-19 | Size | (mm) | Test Result<br>(mm) | Acceptance<br>Criteria (Y/N) |
|----------------------|------------------------------|-------------|----------|---------------------|------------------------------|
| Length | | X-Small | 220 min | 240 - 245 | Y |
| | | Small | 220 min | 240-245 | Y |
| | | Medium | 230 | 240 - 245 | Y |
| | | Large | 230 | 240-243 | Y |
| | | Extra-Large | 230 | 240-243 | Y |
| | | XX-Large | 230 | 240 - 242 | Y |
| Width | | X-Small | 70 ± 10 | 77-79 | Y |
| | | Small | 80 ± 10 | 84-86 | Y |
| | | Medium | 95 ± 10 | 95-97 | Y |
| | | Large | 110 ± 10 | 104-106 | Y |
| | | Extra-Large | 120 ± 10 | 111-115 | Y |
| | | XX-Large | 130 ± 10 | 120-123 | Y |
| Palm Thickness | | X-Small | 0.05 min | 0.12 | Y |
| | | Small | 0.05 min | 0.12 | Y |
| | | Medium | 0.05 min | 0.12 | Y |
| | | Large | 0.05 min | 0.12 | Y |
| | | Extra-Large | 0.05 min | 0.12 | Y |
| | | XX-Large | 0.05 min | 0.12 | Y |
| Finger<br>Thickness | | X-Small | 0.08 min | 0.13 | Y |
| | | Small | 0.08 min | 0.13 | Y |
| | | Medium | 0.05 min | 0.13 | Y |
| | | Large | 0.05 min | 0.13 | Y |
| | | Extra-Large | 0.05 min | 0.13 | Y |
| | | XX-Large | 0.05 min | 0.13 | Y |

# Physical Properties

| Purpose | Test Method | Test Result | | Acceptance<br>Criteria<br>(Y/N) | |
|------------------------|------------------------|-------------------------------------|-------------------|-------------------------------------|---|
| Physical<br>Properties | ASTM D6319-19 Standard | | | | |
| | Before Aging | After Aging at<br>70°C, 166 ± 2 hrs | Before Aging | After Aging at<br>70°C, 166 ± 2 hrs | |
| Tensile<br>Strength | 14 MPa min | 14 MPa min | 17.55 – 20.90 MPa | 15.00 – 19.95 MPa | Y |
| Ultimate<br>Elongation | 500% min | 400% min | 750 – 830% | 625 – 770% | Y |

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Image /page/11/Picture/0 description: The image contains a logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of two parts: a graphic on the left and text on the right. The graphic features a stylized "Ma" in red, overlaid on a blue striped background with a red border. The text reads "PT. MAJA AGUNG" in bold, dark green letters, followed by "LATEXINDO" in a similar font and color. Below this, the text "Manufacturer of Latex Gloves" is written in a smaller, less bold font.

#### Freedom from Holes

| Purpose | Test Method | Test Result | Acceptance<br>Criteria (Y/N) |
|-----------------------|-----------------------------------------|-----------------------------------------------------------------------------|------------------------------|
| Freedom from<br>Holes | ASTM D5151-06 Standard,<br>G-1, AQL 2.5 | XS/XXL – 0/160<br>S/M/XL – 1/250<br>L – 2/250<br>Passed Standard Acceptance | Y |

#### Powder Content

| Purpose | Test Method | Test Result | Acceptance<br>Criteria (Y/N) |
|----------|----------------|-----------------------------------|------------------------------|
| Residual | ASTM D6124-06, | X-Small: 0.34 mg/glove (Average) | Y |
| Powder | < 2.0 mg/glove | Small: 0.35 mg/glove (Average) | Y |
| Content | | Medium: 0.35 mg/glove (Average) | Y |
| | | Large: 0.37 mg/glove (Average) | V |
| | | X-Large: 0.35mg/glove (Average) | Y |
| | | XX-Large: 0.33 mg/glove (Average) | V |

#### c. Permeation Testing

Permeation testing were conducted to support the labeling claim: Tested for use with chemotherapy drugs per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Table below is the summary of minimum breakthrough time.

Warning: Not recommended use with drugs that have low permeation time: Carmustine (58.3 average breakthrough time) and Thiotepa (119 average breakthrough time).

| Purpose<br>Test Chemotherapy Drugs | Test Method | Average<br>Breakthrough Time | Acceptance<br>Criteria<br>(Y/N) |
|-----------------------------------------------------|------------------|------------------------------|---------------------------------|
| Carboplatin (Paraplatin), 10 mg/ml (10,000 ppm) | | > 240 min | Y |
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | ASTM<br>D6978-05 | 58.3 min | N |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | | > 240 min | Y |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) | | > 240 min | Y |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) | | > 240 min | Y |
| Docetaxel, 10 mg/ml (10,000 ppm) | | > 240 min | Y |
| Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) | | > 240 min | Y |
| Etoposide, 20.0 mg/ml (20,000 ppm) | | > 240 min | Y |

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Image /page/12/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of two parts: a stylized "Ma" in red and blue on the left, and the company name in green on the right. Below the company name is the text "Manufacturer of Latex Gloves" in a smaller font size.

| Fluorouracil, 50.0 mg/ml (50,000 ppm) | > 240 min | Y |
|------------------------------------------|-----------|---|
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min | Y |
| Methotrexate, 25 mg/ml (25,000 ppm) | > 240 min | Y |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min | Y |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min | Y |
| ThioTepa, 10.0 mg/ml (10,000 ppm) | 119 min | N |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min | Y |
| Simulated Gastric Acid Fluid | >240 min | Y |
| Fentanyl Citrate Injection 100mcg/2mL | >240 min | Y |

# 8) Summary of Clinical Testing

Not applicable - Clinical data is not needed for gloves or most devices cleared by the 510(k) process.

# 9) Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.