Chemotherapy Gloves

K230847 · 3A Glove Sdn. Bhd. · LZA · Sep 29, 2023 · General Hospital

Device Facts

• Record ID: K230847
• Device Name: Chemotherapy Gloves
• Applicant: 3A Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 29, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three colors.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; worn by clinicians to prevent cross-contamination between patient and examiner. Device features beaded cuffs and is available in fern green, midnight black, and sky blue. Tested per ASTM D6978-05 for permeation resistance against various chemotherapy drugs. Used in clinical settings; operated by healthcare professionals. Output is a physical barrier; protects the wearer from exposure to chemotherapy agents and prevents patient contamination. Benefits include reduced risk of chemical exposure and infection transmission.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ASTM D6319-19 (physical properties) and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Form: Ambidextrous, beaded cuff, powder-free. Sizes: S, M, L, XL. Colors: Fern green, midnight black, sky blue. Standards: ASTM D6319-19 (physical), ASTM D6978-05 (permeation), ASTM D5151-19 (holes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-5, -10, -11. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs. 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

• Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color (K190860)

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.

September 29, 2023

3A Glove Sdn. Bhd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K230847

Trade/Device Name: Chemotherapy Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: September 7, 2023 Received: September 7, 2023

Dear Boyle Wang:

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.

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

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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,

# Allan Guan -S

For 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) K230847

Device Name Chemotherapy Gloves

#### Indications for Use (Describe)

Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three colors.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes (minutes) |
|---------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Carboplatin | 10 mg/ml(10,000 ppm) | > 240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | Midnight black:32.6(33.2,32.6,33.0) min.<br>Sky blue:24.5(25.2,24.5,26.1) min<br>Fern Green:24.3(28.1,26.3,24.3) min. |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 min. |
| Cyclophosphamide | 20.0 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. |
| Epirubicin HCI | 2 mg/ml (2,000 ppm) | > 240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 min. |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 min. |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 min. |
| Ifosfamice | 50 mg/ml (50,000 ppm) | > 240 min. |
| Ifinotecan | 20 mg/ml (20,000 ppm) | > 240 min. |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 min. |
| Mitomycin | 0.5 mg/ml (500 ppm) | > 240 min. |
| Mitoxantrone HCl | 2 mg/ml (2,000 ppm) | > 240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | > 240 min. |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 min. |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | Midnight black: 58.7(87.2,67.8,58.7)<br>Sky blue: 77.3(77.3,85.8,79.8)<br>Fern Green: 67.9(68.4,67.9,79.2) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 min. |

Please note that the following drugs have low permeation times:

Midnight black: Carmustine 3.3 mg/ml 32.6 Minutes (min.); Thio Tepa 10.0 mg/ml 58.7 Minutes (min.). Sky blue: Carmustine 3.3 mg/ml 24.5 Minutes (min.); Thio Tepa 10.0 mg/ml 77.3 Minutes (min.). Fern green: Carmustine 3.3 mg/ml 24.3 Minutes (min.); Thio Tepa 10.0 mg/ml 67.9 Minutes (min.). Warning: Please do not 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)

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

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## 510(k) Summary K230847

This 510(k) Summary is being submitted in accordance with 21 CFR 807.92.

#### 1.0 Submitter's Information

Name: 3A Glove Sdn. Bhd. Address: PTD 2058 & 2059, Jalan Cyber 4, Kawasan Perindustrian Senai (III), 81400 Senai, Johor, Malaysia Phone Number: [phone] Contact: Poh Seng Ping Date of Preparation: 2023.09.26

#### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

#### 2.0 Device Information

Trade name: Chemotherapy Gloves Patient Examination Gloves Common name: Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

#### 3.0 Classification

LZA.LZC. OPJ Product code: Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

#### 4.0 Predicate Device Information

Manufacturer: Ever Growth (Vietnam) Co., Ltd. Device: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy

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Drugs, Orange Color 510(k) number: K190860

#### 5.0 Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large and with fern green, midnight black and sky blue three colors for options to each sizes.

#### 6.0 Indication for Use

Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three colors.

| Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes<br>(minutes) |
|----------------------------|------------------------|--------------------------------------------------------|
| Midnight black carboplatin | 10 mg/ml(10,000 ppm) | > 240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 32.6(33.2,32.6,33.0) min. |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 min. |
| Cyclophosphamide | 20.0 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. |
| Epirubicin HCl | 2 mg/ml (2,000 ppm) | > 240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 min. |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 min. |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 min. |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 min. |
| Irinotecan | 20 mg/ml (20,000 ppm) | > 240 min. |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 min. |
| Mitomycin | 0.5 mg/ml (500 ppm) | > 240 min. |
| Mitoxantrone HCl | 2 mg/ml (2,000 ppm) | > 240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | > 240 min. |

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| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 min. |
|---------------------|------------------------|----------------------|
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 58.7(87.2,67.8,58.7) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 min. |

Please note that the following drugs have low permeation times:

Carmustine 3.3 mg/ml 32.6 Minutes (min.);

Thio Tepa 10.0 mg/ml 58.7 Minutes (min.).

Warning: Please do not use with Carmustine and Thiotepa.

| Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes<br>(minutes) |
|---------------------|------------------------|--------------------------------------------------------|
| Sky blue | 10 mg/ml(10,000 ppm) | > 240 min. |
| carboplatin | 10 mg/ml(10,000 ppm) | > 240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 24.5(25.2,24.5,26.1) min. |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 min. |
| Cyclophosphamide | 20.0 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. |
| Epirubicin HCI | 2 mg/ml (2,000 ppm) | > 240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 min. |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 min. |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 min. |
| Ifosfamice | 50 mg/ml (50,000 ppm) | > 240 min. |
| Ifinotecan | 20 mg/ml (20,000 ppm) | > 240 min. |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 min. |
| Mitomycin | 0.5 mg/ml (500 ppm) | > 240 min. |
| Mitoxantrone HCI | 2 mg/ml (2,000 ppm) | > 240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | > 240 min. |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 min. |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 77.3(77.3,85.8,79.8) |
| Vincristine Sulfate | 1 mg/ml (1.000 ppm) | > 240 min. |

Please note that the following drugs have low permeation times:

Carmustine 3.3 mg/ml 24.5 Minutes (min.); Thio Tepa 10.0 mg/ml 77.3 Minutes (min.).

Warning: Please do not use with Carmustine and Thiotepa.

| Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes<br>(minutes) |
|-------------------|---------------|--------------------------------------------------------|
| Fern Green | | |

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| carboplatin | 10 mg/ml(10,000 ppm) | > 240 min. |
|---------------------|------------------------|---------------------------|
| Carmustine | 3.3 mg/ml (3,300 ppm) | 24.3(28.1,26.3,24.3) min. |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 min. |
| Cyclophosphamide | 20.0 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. |
| Epirubicin HCI | 2 mg/ml (2,000 ppm) | > 240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 min. |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 min. |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 min. |
| Ifosfamice | 50 mg/ml (50,000 ppm) | > 240 min. |
| Ifinotecan | 20 mg/ml (20,000 ppm) | > 240 min. |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 min. |
| Mitomycin | 0.5 mg/ml (500 ppm) | > 240 min. |
| Mitoxantrone HCI | 2 mg/ml (2,000 ppm) | > 240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | > 240 min. |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 min. |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 67.9(68.4,67.9,79.2) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 min. |

Please note that the following drugs have low permeation times:

Carmustine 3.3 mg/ml 24.3 Minutes (min.);

Thio Tepa 10.0 mg/ml 67.9 Minutes (min.).

Warning: Please do not use with Carmustine and Thiotepa.

#### 7.0 Technological Characteristic Comparison Table

#### Table1-General Comparison

| Item | Subject Device<br>K230847 | Predicate Device<br>(K190860) | Remark |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA,LZC, OPJ | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were | Same |

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| | tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 Standard<br>Practice for Assessment of<br>Medical gloves to<br>Permeation<br>by<br>Chemotherapy Drugs. | tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 Standard Practice<br>for Assessment of Medical<br>gloves to<br>Permeation<br>by<br>Chemotherapy Drugs. | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Powdered or<br>powder free | Powder free | Powder free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-use indication,<br>powder free, device color,<br>device name, glove size and<br>quantity, Non-Sterile,<br>a statement of standard<br>ASTM D6978-05<br>compliance and a<br>summary of the testing<br>results. | Single-use indication,<br>powder free, device color,<br>device name, glove size and<br>quantity, Non-Sterile, a<br>statement of standard<br>ASTM D6978-05<br>compliance and a summary<br>of the testing results. | Similar |

#### Table2 Device Dimensions Comparison

| | Size | | | | | | |
|------------------------------|----------------|------|-----|-----|-----|-----------|-----|
| Designation | XS | S | M | L | XL | Tolerance | |
| Predicate<br>Device(K190860) | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | | min |
| Designation | Size | | | | | Tolerance | |
| | | S | M | L | XL | | |
| Subject Device | Length, mm | 220 | 230 | 230 | 230 | | min |
| | Width, mm | 80 | 95 | 110 | 120 | | ±10 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | | min |
| Remark | Analysis 1 | | | | | | |

Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

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| Item | Subject device | Predicate device (K190860) | Remark | |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------|------|
| Color | FERN GREEN/<br>MIDNIGHT BLACK/<br>SKY BLUE | White, Orange | Analysis 2 | |
| Physical<br>Properties | Before Aging:<br>Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | Before Aging:<br>Ultimate Elongation | 500% min | 500% min | Same |
| Physical<br>Properties | After Aging:<br>Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | After Aging:<br>Ultimate Elongation | 400%min | 400%min | Same |
| | Comply with ASTM D6319 | | Comply with ASTM D6319 | Same |
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same | |
| Powder Content | Fern Green 0.6 mg/glove<br>Midnight black 1.1 mg/glove<br>Sky blue 1.0 mg/glove | <= 2 mg/glove | Similar | |
| Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as Tested per ASTM D 6978 | carboplatin<br>10 mg/ml(10,000 ppm)<br>> 240 min. | NA | Analysis 3 | |
| | Carmustine<br>3.3 mg/ml (3,300 ppm)<br>Fern Green:<br>24.3(28.1,26.3,24.3) min.<br>Sky blue: 24.5(25.2,24.5,26.1) min.<br>Midnight black:<br>32.6(33.2,32.6,33.0) min. | Carmustine (BCNU)<br>3.3 mg/ml:<br>White:11.8 Minutes;<br>Orange:31.6Minutes | Similar | |
| | Cisplatin<br>1.0 mg/ml(1,000 ppm)<br>> 240 min. | Cisplatin 1.0 mg/ml:<br>>240 Minutes | Same | |
| | Cyclophosphamide<br>20.0 mg/ml(20,000 ppm)<br>> 240 min. | Cyclophosphamide (Cytoxan)<br>20.0 mg/ml: > 240 Minutes | Same | |
| | Dacarbazine | Dacarbazine (DTIC) | Same | |

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| 10 mg/ml (10,000 ppm)<br>> 240 min. | 10.0 mg/ml:<br>>240 Minutes | |
|-------------------------------------------------------|----------------------------------------------------------|------------|
| Docetaxel<br>10 mg/ml (10,000 ppm)<br>> 240 min. | NA | Analysis 5 |
| Doxorubicin HCL<br>2.0 mg/ml(2,000 ppm)<br>> 240 min. | Doxorubicin<br>Hydrochloride 2.0 mg/ml:<br>> 240 Minutes | Similar |
| Epirubicin HCI<br>2 mg/ml (2,000 ppm)<br>> 240 min. | NA | Analysis 5 |
| Etoposide<br>20 mg/ml (20,000 ppm)<br>> 240 min. | Etoposide (Toposar)<br>20.0 mg/ml:<br>> 240 Minutes | Similar |
| Fluorouracil<br>50.0 mg/ml(50,000 ppm)<br>> 240 min. | Fluorouracil 50.0 mg/ml:<br>>240 Minutes | Same |
| Gemcitabine<br>38 mg/ml (38,000 ppm)<br>> 240 min. | NA | Analysis 5 |
| Ifosfamice<br>50 mg/ml (50,000 ppm)<br>> 240 min | NA | Analysis 5 |
| Ifinotecan<br>20 mg/ml (20,000 ppm)<br>> 240 min. | NA | Analysis 5 |
| Methotrexate<br>25 mg/ml (25,000 ppm)<br>> 240 min | NA | Analysis 5 |
| Mitomycin<br>0.5 mg/ml (500 ppm)<br>> 240 min. | NA | Analysis 5 |
| Mitoxantrone HCI<br>2 mg/ml (2,000 ppm)<br>> 240 min. | NA | Analysis 5 |
| Oxaliplatin<br>5 mg/ml (5,000 ppm)<br>> 240 min. | NA | Analysis 5 |
| Paclitaxel<br>6.0 mg/ml(6,000 ppm)<br>> 240 min. | Paclitaxel (Taxol) 6.0<br>mg/ml:<br>>240 Minutes | Same |
| Thio Tepa<br>10.0 mg/ml (10,000 ppm)<br>> 240 min. | Thio-Tepa<br>10.0 | Similar |

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| 10.0 mg/ml(10,000 ppm) | | mg/ml: | White:16.9 |
|---------------------------|--------|----------------------|------------|
| Fern | Green: | Minutes; | |
| 67.9(68.4,67.9,79.2)min. | | Orange: 72.5 Minutes | |
| Sky | blue: | | |
| 77.3(77.3,85.8,79.8)min. | | | |
| Midnight | black: | | |
| 58.7(87.2,67.8,58.7) min. | | | |
| Vincristine Sulfate | | NA | Analysis 5 |
| 1 mg/ml (1,000 ppm) | | | |
| > 240 min. | | | |

Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the performance and biocompatibility tests, the test results shown that the color difference do not effect the safety and performance of proposed device.

Analysis 3: More Chemotherapy Drugs Tested with proposed devices than those with Predicate device. But all proposed devices are conducted the chemo drugs test, the test results shown that they comply with the requirements of standard ASTM D6978, so the differences do not raise any new safety or performance questions.

| Item | | Proposed device | Predicate device | Remark |
|--------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------|
| Material | | Nitrile | Nitrile | SAME |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| | Sensitization | Under conditions of the study, not a sensitizer. | | |
| | Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | Analysis 6 |
| | Acute Systemic toxicity | Under the conditions of the study, the device does not elicit acute systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | |
| Label and Labeling | | Meet FDA's Requirement | Meet FDA's Requirement | SAME |

#### Table4 Safety Comparison

Analysis 6: The proposed device is potentially cytotoxic, but all proposed devices are conducted the acute systemic toxicity test, the test results show that the proposed device is safe.

#### 8.0 Summary of Non-Clinical Testing

#### Biocompatibility Testing

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The biocompatibility evaluation for Chemotherapy Gloves was conducted in accordance with the following standards:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity

#### Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation bv Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.

In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in ー Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- D6978-05 (Reapproved 2019) Standard Practice । ASTM for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

#### 9.0 Summary of Clinical Testing

Clinical testing is not needed for this device.

#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject

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device, Chemotherapy Gloves is as safe, as effective, and performs as well as or better than the legally marketed Predicate device under K190860.