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

K221271 · Shandong Maida Medical Technology Co., Ltd. · LZA · Jul 27, 2022 · General Hospital

Device Facts

• Record ID: K221271
• Device Name: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
• Applicant: Shandong Maida Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 27, 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, powder-free, ambidextrous nitrile examination gloves; blue color; beaded cuff. Used by healthcare professionals in clinical settings to prevent cross-contamination between examiner and patient. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Output is a physical barrier; healthcare providers use gloves during patient examinations and procedures involving chemotherapy agents. Benefits include protection against biological contaminants and specific chemotherapy drug exposure, excluding Carmustine and Thiotepa due to low breakthrough times.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ASTM D6319-19 (physical properties, dimensions), ASTM D6124-06 (residual powder), ASTM D5151-19 (freedom from holes), and ASTM D6978-05 (chemotherapy permeation). Biocompatibility testing conducted per ISO 10993-10 (irritation/sensitization), ISO 10993-5 (cytotoxicity), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Form: Powder-free, ambidextrous, beaded cuff, blue. Standards: ASTM D6319-19 (physical), ASTM D6124-06 (powder), ASTM D5151-19 (holes), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: ISO 10993-5, 10, 11. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs.

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, 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). 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 a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 27, 2022

Shandong Maida Medical Technology Co.,Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K221271

Trade/Device Name: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: April 18, 2022 Received: May 2, 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 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.

Clarence W. Murray, III, 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) K221271

#### Device Name

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

#### 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.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|----------------------------|------------------------|----------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 22.8(23.7, 22.8, 23.1) Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Doxorubicin | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 46.8(48.2, 48.6, 46.8) Minutes |

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.8 Minutes (min.); Thio Tepa 10.0 mg/ml 46.8 Minutes (min.). Warning: Please do not use with Carmustine (BCNU) and Thiotepa.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="checked" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# K221271 510(k) Summary

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

#### 1.0 Submitter's Information

Name: Shandong Maida Medical Technology Co.,Ltd. Address: Room 102, Eastern building, No.166, South 1st Road, Development zone, Dongying, Shandong, China Room 102, Eastern building, No.166, South 1st Road, Development Contact: zone, Dongying, Shandong, China Date of Preparation: 2022.04.25

#### Designated Submission Correspondent

Mr. Boyle Wanq 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: for Use with Chemotherapy Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

#### 3.0 Classification

| Production code: | LZA, LZC |
|--------------------|------------------|
| Regulation number: | 21CFR880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |

#### 4.0 Predicate Device Information

Manufacturer: Ever Growth (Vietnam) Co., Ltd.

Disposable Powder Free Nitrile Examination Glove, Tested For Device: Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove. Tested For Use With Chemotherapy Drugs, Orange Color

510(k) number: K190860

### 5.0 Device Description

The subject device is single use, disposable gloves intended for medical

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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 colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: extra-small, small, medium, large, and extra-large.

## 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<br>(minutes) |
|-------------------------------|------------------------|--------------------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 22.8(23.7, 22.8, 23.1) |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide<br>(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 |
| Doxorubicin | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 46.8(48.2, 48.6, 46.8) |

Please note that the following drugs have low permeation times:

Carmustine (BCNU) 3.3 mg/ml 22.8 Minutes (min.);

Thio Tepa 10.0 mg/ml 46.8 Minutes (min.).

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

### 7.0 Technological Characteristic Comparison Table

| Item | Subject Device<br>Pending | Predicate Device<br>(K190860) | Comparison |
|----------------|---------------------------|-------------------------------|------------|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |

#### Table1-General Comparison

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| Intended Use | A patient examination<br>gloves is a disposable<br>device intended for medical<br>purpose that is worn on the<br>examiner's hand or<br>fingers to prevent<br>contamination between<br>patient and examiner. In<br>addition, these gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 Standard<br>Practice for Assessment of | A patient examination gloves<br>is a disposable device<br>intended for medical purpose<br>that is worn on the<br>examiner's hand or<br>fingers to prevent<br>contamination between<br>patient and examiner. In<br>addition, these gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 Standard Practice<br>for Assessment of Medical | Same |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Medical gloves to<br>Permeation<br>by<br>Chemotherapy Drugs. | Medical gloves to<br>Permeation<br>by<br>Chemotherapy Drugs. | |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-use<br>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<br>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

| Predicate<br>Device(K190860) | Designation | Size | | | | | Tolerance |
|------------------------------|-------------|------|-----|-----|-----|-----------|-----------|
| | | XS | S | M | L | XL | |
| | 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 |
| Subject Device | Designation | Size | | | | Tolerance | |
| | | S | M | L | XL | | |
| | Length, mm | 220 | 230 | 230 | 230 | min | |
| | Width, mm | 80 | 95 | 110 | 120 | ±10 | |

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| | Thickness, mm: | | |
|--------|----------------|------|-----|
| | Finger | 0.05 | min |
| | Palm | 0.05 | min |
| Remark | Different | | |

Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19.

| Item | Subject device | Predicate device<br>(K190860) | Comparison | |
|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------|------------------------------------------------------------------------------|---------|
| Colorant | Blue | White, Orange | Different 1 | |
| Physical<br>Properties | Before Aging<br>Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | Before Aging<br>Ultimate Elongation | 500% min | 500% min | Same |
| | 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 | 0.15-0.19 mg per glove, Meet the requirements of ASTM D6124 | | Meet the requirements of ASTM D6124 | Same |
| Chemotherapy Drugs<br>Tested with Minimum<br>Breakthrough<br>Detection Time as<br>Tested per ASTM D<br>6978 | Carmustine (BCNU) 3.3 mg/ml:<br>22.8 Minutes (min.) | | Carmustine (BCNU)<br>3.3 mg/ml:<br>White:11.8 Minutes;<br>Orange:31.6Minutes | Similar |
| | Cisplatin 1.0 mg/ml: > 240 Minutes | | Cisplatin 1.0 mg/ml: > 240 Minutes | Same |
| | Cyclophosphamide (Cytoxan)<br>20.0 mg/ml: > 240 Minutes | | Cyclophosphamide (Cytoxan)<br>20.0 mg/ml: > 240 Minutes | Same |
| | Dacarbazine 10 mg/ml:> 240 Minutes | | Dacarbazine (DTIC)<br>10.0 mg/ml:<br>>240 Minutes | Same |

## Table3 Performance Comparison

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| | Doxorubicin 2.0 mg/ml: ><br>240 Minutes | Doxorubicin<br>Hydrochloride 2.0<br>mg/ml: >240 Minutes | Similar |
|--|---------------------------------------------|----------------------------------------------------------------------|---------|
| | Etoposide 20.0 mg/ml: > 240<br>Minutes | Etoposide (Toposar)<br>20.0<br>mg/ml: >240 Minutes | Similar |
| | Fluorouracil 50.0 mg/ml: ><br>240 Minutes | Fluorouracil 50.0<br>mg/ml: >240<br>Minutes | Same |
| | Paclitaxel 6.0 mg/ml: >240<br>Minutes | Paclitaxel (Taxol) 6.0<br>mg/ml:<br>>240 Minutes | Same |
| | Thio Tepa 10.0 mg/ml:<br>46.8Minutes (min.) | Thio-Tepa 10.0 mg/ml:<br>White:16.9 Minutes;<br>Orange: 72.5 Minutes | Similar |

Analysis:

Different 1: The color of the subject device is different of that of the predicate. Biocompatibility testing was successfully completed for the subject device.

#### Table4 Safety Comparison

| Item | | Proposed device | Predicated device | Comparison |
|----------------------|----------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------|
| Material | | Nitrile | Nitrile | SAME |
| Biocompati<br>bility | Irritation | Under the conditions of the study, not an irritant | Comply with<br>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<br>ISO10993-5 | Analysis3 |
| | Systemic<br>toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO<br>10993-11 Third edition<br>2017-09 | |
| Label and Labeling | | Meet FDA's Requirement | Meet FDA's<br>Requirement | SAME |

Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test.

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#### 8.0 Summary of Non-Clinical Testing

#### Biocompatibility Testing

biocompatibility evaluation for Disposable Nitrile Powder-Free The 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 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 D6319-10, Standard Specification for Disposable Nitrile Powder-Free 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 Disposable Nitrile -Powder-Free 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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| No. | Name of the Test<br>Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-10:2010<br>Biological Evaluation Of<br>Medical Devices - Part<br>10: Tests For Irritation<br>And Skin Sensitization. | This part of ISO<br>10993 assesses<br>possible contact<br>hazards from<br>chemicals<br>released from<br>medical devices, | Skin Sensitization<br>Test:<br>provided<br>grades less than 1,<br>otherwise<br>sensitization. | All grades are 0.<br><br>All animals were survived and no<br>abnormal signs were observed<br>during the study. |
| 2 | | which may<br>produce skin and<br>mucosal irritation,<br>eye irritation or<br>skin sensitization. | Skin Irritation Test:<br>If the primary irritation<br>index is 0-0,4, the<br>response category is<br>Negligible.<br>0,5-1,9 means slight<br>2-4,9 means moderate<br>5-8 means severe | The primary irritation index is 0.<br><br>The response of the proposed<br>device was categorized as<br>negligible under the test<br>condition |
| 3 | ISO 10993-5:2009<br>Biological Evaluation Of<br>Medical Devices - Part<br>5: Tests For In Vitro<br>Cytotoxicity | This part of ISO<br>10993 describes<br>test methods to<br>assess the in vitro<br>cytotoxicity of<br>medical devices. | The viab.% of the<br>100% extract of the<br>test article is the final<br>result, and if viability is<br>reduced to <70% of<br>the blank, it has<br>cytotoxic potential. | Viab.% of 100% test article<br>extract is 17.1%<br><br>It means the proposed device<br>have potential toxicity to L-929 in<br>the MTT method |
| 4 | ISO 10993-11: 2017<br>Biological evaluation of<br>medical devices — Part<br>11: Tests for systemic<br>toxicity | To evaluate the<br>potential for<br>medical device<br>materials to cause<br>adverse systemic<br>reactions. | Within the monitoring<br>period (72 h), if the<br>toxicosis response of<br>testing group is not<br>greater than that of<br>control group, the<br>testing sample is<br>regarded as<br>acceptable. | There was no evidence of<br>systemic toxicity from the extract. |
| 5 | ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | This standard is<br>designed to<br>determine the<br>amount ofresidual<br>powder (or<br>filter-retained<br>mass) found<br>on medical gloves | powder residue limit of<br>2.0 mg | 0.15-0.19 mg /glove |
| 6 | ASTM<br>D5151-06(Reapproved2<br>015), Standard Test<br>Method for Detection of<br>Holes in Medical Gloves. | This test method<br>covers the<br>detection of holes<br>in<br>medical gloves. | Samples number: 125<br>gloves<br>AQL: 2.5 (ISO 2859)<br>Criterion ≤7 gloves<br>for water leakage | no glove water leakage found |
| 7 | ASTM<br>D6319-10(Reapproved<br>2015), Standard<br>Specification For Nitrile<br>Examination Gloves For<br>Medical Application. | This specification<br>covers certain<br>requirements for<br>nitrile rubber<br>gloves used in<br>conducting<br>medical<br>examinations and<br>diagnostic and<br>therapeutic<br>procedures. | Sterility: no need<br>Freedom from holes:<br>pl. Refer to No. 5 in<br>table 5<br>Dimensions:<br>S: width 80±10mm<br>Length ≥220 mm<br>M: width 95±10mm<br>Length ≥230 mm<br>L: width 110±10mm<br>Length ≥230 mm<br>XL: width 120±10mm<br>Length ≥230 mm<br>Thickness:<br>Finger ≥0.05 mm<br>Palm ≥0.05 mm | N.A.<br>Please refer to No. 5 in table 5<br>Lot no.:210515<br>Dimensions:<br>S: width: 85-87 mm<br>Length 247-253 mm<br>M: width 88-96 mm<br>Length 242-257 mm<br>L: width 90-99 mm<br>Length 240-254 mm<br>XL: width 110-115 mm<br>Length 245-253 mm<br>Thickness:<br>Finger 0.09-0.21 mm<br>Palm 0.06-0.15 mm<br><br>Physical properties:<br>Before aging<br>Tensile strength 14.1-22.5 MPa<br>Ultimate Elongation 503.274% -<br>670.613%<br>After Accelerated Aging<br>Tensile strength 14.6-20.8 MPa<br>Ultimate Elongation 411.403% -<br>592.683%<br><br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5<br>Lot no.:210518<br>Dimensions:<br>S: width: 84-86 mm<br>Length 248-256 mm<br>M: width 95-96 mm<br>Length 237-266 mm<br>L: width 105-108 mm |

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| | | Length 257-262 mm |
|--|--|--------------------------------|
| | | XL: width 114-117 mm |
| | | Length 252-262 mm |
| | | Thickness: |
| | | Finger 0.10-0.12mm |
| | | Palm 0.07-0.08mm |
| | | |
| | | |
| | | Physical properties: |
| | | Before aging |
| | | Tensile strength 15.2-29.8 MPa |
| | | Ultimate Elongation 500.492% - |
| | | 593.853% |
| | | After<br>Aging |
| | | Tensile strength 14.1-23.8MPa |
| | | Ultimate Elongation 451.751% - |
| | | 597.368% |
| | | |
| | | Powder-free Residue: |
| | | pl. Refer to No. 4 in table 5 |
| | | |
| | | Lot no.:210520 |
| | | Dimensions: |
| | | S: width: 84-87 mm |
| | | Length 244-257 mm |
| | | M: width 93-98 mm |
| | | Length 245-260 mm |
| | | L: width 104-110mm |
| | | Length 250-263 mm |
| | | XL: width 114-119 mm |
| | | Length 252-260 mm |
| | | Thickness: |
| | | Finger 0.10-0.12 mm |
| | | Palm 0.06-0.08 mm |
| | | |
| | | |
| | | Physical properties: |
| | | Before aging |
| | | Tensile strength 14.4-23.9MPa |
| | | Ultimate Elongation 501.484% - |
| | | 547.660% |
| | | After Accelerated Aging |
| | | Tensile strength 14.2-23.9 MPa |
| | | Ultimate Elongation 492.901% - |
| | | |

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| | | | | 599.996%<br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5 |
|---|----------------|-----------------------------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------|
| 8 | ASTM D<br>6978 | Chemotherapy<br>Drugs<br>Tested with<br>Minimum<br>Breakthrough<br>Detection Time | Carmustine (BCNU) 3.3 mg/ml: 22.8 Minutes (min.) | |
| | | | Cisplatin 1.0 mg/ml: > 240 Minutes | |
| | | | Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |
| | | | Dacarbazine 10 mg/ml:> 240 Minutes | |
| | | | Doxorubicin 2.0 mg/ml: > 240 Minutes | |
| | | | Etoposide 20.0 mg/ml: > 240 Minutes | |
| | | | Fluorouracil 50.0 mg/ml: >240 Minutes | |
| | | | Paclitaxel 6.0 mg/ml: >240 Minutes | |
| | | | Thio Tepa 10.0 mg/ml: 46.8Minutes (min.) | |

## 9.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

{13}------------------------------------------------

#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.