Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple

K220382 · Jiangsu Bytech Medical Supplies Co., Ltd. · LZA · Apr 21, 2022 · General Hospital

Device Facts

• Record ID: K220382
• Device Name: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple
• Applicant: Jiangsu Bytech Medical Supplies Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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 tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; available in blue, black, and purple; sizes S, M, L, XL. Worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for resistance to chemotherapy drug permeation per ASTM D6978-05. Provides barrier protection; however, specific drugs (Carmustine, ThioTepa) show low breakthrough times, necessitating warnings against use with these agents. Used in clinical settings; no specialized operation required.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ASTM D6319, D6124, D5151, D412, and D6978-05. Biocompatibility testing conducted per ISO 10993-5, 10993-10, and 10993-11.

Technological Characteristics

Material: Nitrile. Design: Powder-free, ambidextrous, beaded cuff. Dimensions: Length ≥220-230mm, thickness ≥0.05mm. Standards: ASTM D6319 (physical), ASTM D6978-05 (chemo permeation), ASTM D6124 (powder), ASTM D5151 (holes), ASTM D412 (tensile). Biocompatibility: ISO 10993 series. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on examiner's hands/fingers to prevent cross-contamination. Tested for use with specific chemotherapy drugs per ASTM D6978-05. Contraindicated for use with Carmustine and ThioTepa due to low permeation breakthrough times.

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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

April 21, 2022

Jiangsu Bytech Medical Supplies Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai. 200120 China

Re: K220382

Trade/Device Name: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: January 28, 2022 Received: February 10, 2022

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.

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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.

Clarence W. Murray, III, PhD 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) K220382

Device Name

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)- Blue/Black/Purple

#### Indications for Use (Describe)

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 tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

1. The following is the resistance to permeation by chemotherapy drugs for the blue gloves.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---------------------|---------------|----------------------------------------|
| Carmustine | 3.3 mg/ml | 26.6 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Methotrexate | 25.0 mg/ml | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 58.8 Minutes |
| Vincristine Sulfate | 1.0 mg/ml | > 240 Minutes |

Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 26.6 Minutes ThioTepa 10.0 mg/ml 58.8 Minutes Warning: Please do not use with Carmustine and ThioTepa.

2. The following is the resistance to permeation by chemotherapy drugs for the black gloves.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---------------------|---------------|----------------------------------------|
| Carmustine | 3.3 mg/ml | 27.3 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Methotrexate | 25.0 mg/ml | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 77.8 Minutes |
| Vincristine Sulfate | 1.0 mg/ml | > 240 Minutes |

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Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 27.3 Minutes ThioTepa 10.0 mg/ml 77.8 Minutes Warning: Please do not use with Carmustine and ThioTepa.

3. The following is the resistance to permeation by chemotherapy drugs for the purple gloves.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---------------------|---------------|----------------------------------------|
| Carmustine | 3.3 mg/ml | 23.5 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Methotrexate | 25.0 mg/ml | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 56.1 Minutes |
| Vincristine Sulfate | 1.0 mg/ml | > 240 Minutes |

Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 23.5 Minutes ThioTepa 10.0 mg/ml 56.1 Minutes 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)

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# 510(k) Summary K220382

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

#### 1.0 Submitter's Information

Jiangsu Bytech Medical Supplies Co.,Ltd. Name: Address: NO.88 Junshi Road, Petroleum Equipment Industrial Park, Jianyang Town, Jianhu County, Yancheng City, Jiangsu Province, China Contact: Shen Hongxing Date of Preparation: Jan.28, 2022

#### 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: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple Patient Examination Gloves Common name: Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

#### 3.0 Classification

Production code: LZA, LZC Requlation 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, blue/black/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: S, M, L, XL. The subject device is non-sterile.

#### 6.0 Indication for Use

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 tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs

| Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes |
|---------------------|---------------|-------------------------------------------|
| Carmustine | 3.3 mg/ml | 26.6 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 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 | 58.8 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |

6.1 The following is the resistance to permeation by chemotherapy drugs for the blue gloves.

Please note that the following drugs have low permeation times:

Carmustine (BCNU) 3.3 mg/ml 26.6 Minutes;

Thio Tepa 10.0 mg/ml 58.8 Minutes.

Warning: Please do not use with Carmustine and ThioTepa.

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6.2 The following is the resistance to permeation by chemotherapy drugs for the black gloves.

| Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes |
|---------------------|---------------|-------------------------------------------|
| Carmustine | 3.3 mg/ml | 27.3 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 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 |
| Thio Tepa | 10.0 mg/ml | 77.8 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |

Please note that the following drugs have low permeation times:

Carmustine (BCNU) 3.3 mg/ml 27.3 Minutes;

Thio Tepa 10.0 mg/ml 77.8 Minutes.

Warning: Please do not use with Carmustine (BCNU) and ThioTepa.

6.3 The following is the resistance to permeation by chemotherapy drugs for the purple gloves.

| Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes |
|-------------------|---------------|-------------------------------------------|
| Carmustine | 3.3 mg/ml | 23.5 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 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 |
| Thio Tepa | 10.0 mg/ml | 56.1 |

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| Vincristine Sulfate | 1.0 mg/ml | > 240 |
|---------------------|-----------|-------|
|---------------------|-----------|-------|

Please note that the following drugs have low permeation times:

Carmustine (BCNU) 3.3 mg/ml 23.5 Minutes;

Thio Tepa 10.0 mg/ml 56.1 Minutes.

Warning: Please do not use with Carmustine (BCNU) and ThioTepa.

#### 7.0Technological Characteristic Comparison Table

| Table1-General Comparison | | | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Item | Subject Device<br>(K220382) | Predicate Device<br>(K190860) | Remark |
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | 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 tested for use with chemotherapydrugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | 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 tested for use with chemotherapydrugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 | Same |

#### Table1-General Comparison

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| | | compliance<br>and<br>a<br>summary of the testing<br>results. | compliance<br>and<br>a<br>summary of the testing<br>results. | | |
|------------------------|--------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------|
| | | Length:<br>XS/S:≥220;<br>M/L/XL/XXL: ≥230;<br>Width:<br>S: 80±10;<br>M: 95±10;<br>L: 110±10;<br>XL: 120±10. | Length:<br>XS/S/M/L/XL: ≥230;<br>Width:<br>XS:70±10;<br>S: 80±10;<br>M: 95±10;<br>L: 110±10;<br>XL: 120±10 | Similar | |
| Thickness(mm) | | Finger: ≥0.05;<br>Palm: ≥0.05 | Finger: ≥0.05;<br>Palm: ≥0.05 | | Same |
| Colorant | | Blue, Black, Purple | White, Orange | | Different |
| Physical<br>Properties | Before<br>Aging | Tensile Strength 14MPa, min<br>Ultimate Elongation 500% min | Tensile Strength 14MPa, min<br>Ultimate Elongation 500% min | | Same |
| | After Aging | Tensile Strength 14MPa, min<br>Ultimate Elongation 400%min | Tensile Strength 14MPa, min<br>Ultimate Elongation 400%min | Same | |
| | Freedom from Holes | | Be free from holes when tested in accordance with ASTMD5151<br>AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151<br>AQL=2.5 | Same |
| | Powder Content | | 0.11~0.16 mg per glove,<br>Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Similar |
| Biocompatibility | | | ISO 10993-10;<br>Under the conditions of the study, not an irritant or a sensitizer | ISO 10993-10;<br>Under the conditions of the study, not an irritant or a sensitizer | Same |
| | | | ISO 10993-5<br>Under conditions of the study, device extract is cytotoxic | ISO 10993-5<br>Under conditions of the study, device extract is not cytotoxic | / |
| | | | ISO 10993-11;<br>Under the condition of acute systemic toxicity test,<br>the test article did not show acute systemic toxicity in vivo | / | / |

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| Chemotherapy<br>Drugs Tested<br>with Minimum<br>Breakthrough<br>Detection Time<br>as Tested per<br>ASTM D 6978 | Carmustine<br>3.3 mg/ml | Blue: 26.6 Minutes<br>Black: 27.3 Minutes<br>Purple: 23.5 Minutes | White:11.8 Minutes;<br>Orange:31.6Minutes | Similar |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------|---------------------------------------------|-----------|
| | Cisplatin<br>1.0 mg/ml | >240 Minutes | >240 Minutes | Different |
| | Cyclophosph<br>-amide<br>20.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Dacarbazine<br>10.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Doxorubicin<br>HCI<br>2.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Etoposide<br>20.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Fluorouracil<br>50.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Methotrexate<br>25.0 mg/ml | >240 Minutes | / | Different |
| | Mitomycin C<br>0.5 mg/ml | >240 Minutes | / | Different |
| | Paclitaxel<br>6.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Thio Tepa<br>10.0 mg/ml | Blue: 58.8 Minutes<br>Black: 77.8 Minutes<br>Purple: 56.1 Minutes | White:16.9 Minutes;<br>Orange: 72.5 Minutes | Different |
| | Vincristine<br>Sulfate<br>1.0 mg/ml | >240 Minutes | / | Different |

#### Analysis 1:

The physical dimensions are different with that of the predicate.

Analysis 2:

The color of the subject device is different with that of the predicate.

Analysis 3: Powder Content of subject device is similar with that of the predicate.

Analysis 4:

And Breakthrough detection times of Carmustine and Thio Tepa of subject device are different with those of the predicate.

## 8.0 Summary of Non-Clinical Testing

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#### Biocompatibility Testing

The biocompatibility evaluation for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) 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 10993-11:2017, 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 D6319-10, 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. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by 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 -Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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| Test Method | Purpose | Acceptance Criteria | Results | |
|-----------------|--------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|
| ASTM D6319 | Physical Dimensions Test | Length(mm):<br>S: ≥220;<br>M/L/XL: ≥230. | Length(mm):<br>S: ≥220;<br>M/L/XL: ≥230. | |
| | | Width(mm):<br>S: 80±10;<br>M: 95±10;<br>L: 110±10;<br>XL: 120±10. | Width(mm):<br>S: 84-87/Pass<br>M: 95-98/ Pass<br>L: 105-109/ Pass<br>XL:113-117/ Pass | |
| | | Finger: ≥0.05;<br>Palm: ≥0.05 | Thickness (mm):<br>Finger:<br>0.10-0.12/Pass<br>Palm:<br>0.07-0.09/Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151<br>AQL 2.5 | 0/125/Pass | |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 <<br>2.0mg | 0.11-0.16mg/Pass | |
| ASTM D412 | Physical properties | Before Aging | Tensile Strength ≥14MPa | 15.5-35.6MPa/Pass |
| | | | Ultimate Elongation ≥500% | 513-599%/Pass |
| | | After Aging | Tensile Strength ≥14MPa | 14.3-25.3MPa/Pass |
| | | | Ultimate Elongation ≥400% | 484-576%/Pass |
| ISO | Cytotoxicity | Non- In Vitro Cytotoxicity | Under conditions of | |
| 10993-5 | | | the study, device extract is cytotoxic. | |
| ISO<br>10993-11 | Cytotoxicity | Non- acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass | |
| ISO<br>10993-10 | Irritation | Non-irritating | Under conditions of the study, not an irritant. / Pass | |
| ISO<br>10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass | |

# Table 2 - Summary of non-clinical performance testing

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## 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 device, Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.