Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs

K212036 · Jiangsu Yanfang Medical Technology Co., Ltd. · LZA · Oct 5, 2021 · General Hospital

Device Facts

• Record ID: K212036
• Device Name: Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
• Applicant: Jiangsu Yanfang Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 5, 2021
• 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, blue nitrile examination gloves; intended for use by healthcare professionals to prevent cross-contamination during patient examinations. Device provides a barrier against patient fluids and specific chemotherapy agents. Users don gloves manually; performance verified via ASTM D6978-05 permeation testing for various chemotherapy drugs. Breakthrough detection times provided for 20 specific agents; warning issued against use with Carmustine (BCNU) due to low permeation time. Benefits include protection of the examiner from patient pathogens and hazardous chemotherapy drug exposure.

Clinical Evidence

No clinical data. Bench testing only. Compliance demonstrated via ASTM D6124-06 (residual powder), ASTM D5151-19 (water tightness/holes), ASTM D6319-19 (physical dimensions/properties), and ASTM D6978-05 (chemotherapy permeation). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

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

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs. Contraindicated for use with Carmustine (BCNU).

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, Blue Color, Tested For Use With Chemotherapy Drugs (K190736)

Submission Summary (Full Text)

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October 5, 2021

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

Re: K212036

Trade/Device Name: 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: August 25, 2021 Received: August 31, 2021

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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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.

For 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) K212036

#### Device Name

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 |
|----------------------------|------------------------|----------------------------------------|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.4 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Epirubicin HCI | 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 |
| Gemcitabine | 38.0 mg/ml(38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Irinotecan | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 Minutes |
| Mitoxantrone | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Oxaliplatin | 5.0 mg/ml(5,000 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 98.6 Minutes |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes Thio Tepa 10.0 mg/ml 98.6 Minutes

Thio Tepa 10.0 mg/ml 98.0 Minutes
VIII in Plasma at -19C

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

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 (K212036)

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

#### 1.0 Submitter's Information

Jiangsu Yanfang Medical Technology Co., Ltd. Name: Address: No.16, Kaiyuan Road, Changjing Town, Jiangyin, Wuxi, Jiangsu, China 214411. Contact: Kaijian Wei Date of Preparation: Oct.05,2021

#### Designated Submission Correspondent

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

#### 2.0 Device Information

Nitrile Powder Free Examination Gloves, Trade name: Tested 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. Device: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs 510(k) number: K190736

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### 5.0 Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands or fingers 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: 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 |
|-------------------------------|------------------------|-------------------------------------------|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.4 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide<br>(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine | 10.0 mg/ml(10,000 ppm) | > 240 |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Epirubicin HCI | 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 |
| Gemcitabine | 38.0 mg/ml(38,000 ppm) | > 240 |
| Ifosfamide | 50.0 mg/ml(50,000 ppm) | > 240 |
| Irinotecan | 20.0 mg/ml(20,000 ppm) | > 240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 |
| Mitoxantrone | 2.0 mg/ml(2,000 ppm) | > 240 |
| Oxaliplatin | 5.0 mg/ml(5,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 98.6 |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 |

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

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Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes Thio Tepa 10.0 mg/ml 98.6 Minutes Warning: Please do not use with Carmustine (BCNU).

## 7.0 Technological Characteristic Comparison Table

| Item | Subject Device | Predicate Device | Remark |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | LZA,LZC | LZA,LZC | Same |
| 510(k) Reference | K212036 | K190736 | 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 chemotherapy drugs 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 chemotherapy drugs 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 |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Color | Blue | Blue | 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 compliance and a summary of the testing results. | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Similar |
| Dimensions - Length | Complies with ASTM | Complies with ASTM D6319- | Similar |
| | D6319-19: | 19: ≥230 mm. | |
| | S: ≥220 mm;<br>M/L/XL: ≥230 mm. | ≥230 mm. | |
| Dimensions - Width | Complies with ASTM D6319-19:<br>S:80±10mm;<br>M:95±10mm;<br>L: 110±10mm;<br>XL: 120±10mm; | Complies with ASTM D6319-19:<br>XS: 70±10mm;<br>S:80±10mm;<br>M:95±10mm;<br>L: 110±10mm;<br>XL: 120±10mm; | Similar |
| Dimensions - Thickness | Complies with ASTM D6319-19<br>Palm:≥0.05mm<br>Finger: ≥0.05mm | Complies with ASTM D6319-19<br>Palm:≥0.05mm<br>Finger: ≥0.05mm | Same |
| Physical Properties - Tensile Strength | Complies with ASTM D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥500% | Complies with ASTM D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥500% | Same |
| Physical Properties - Elongation | Complies with ASTM D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥400% | Complies with ASTM D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥400% | Same |
| Freedom from Holes | Complies with ASTM D6319-19<br>and ASTM D5151-19<br>G-1, AQL 2.5 | Complies with ASTM D6319-19<br>and ASTM D5151-19<br>G-1, AQL 2.5 | Same |
| Powder Content | Complies with ASTM D6319-19,< 2 mg per glove | Complies with ASTM D6319-19,< 2 mg per glove | Same |
| Biocompatibility | Complies with ISO<br>10993-5 (2009)<br>* Under the conditions of the<br>study, the device is not<br>cytotoxic.<br>Complies with ISO<br>10993-10 (2010)<br>* Under the conditions of the<br>study, the device is a non-<br>irritant and a non-sensitizer. | Comply with ISO10993-<br>10(2010) and ISO<br>10993-5 (2009) | Same |
| Chemotherapy drugs tested | | Breakthrough Detection Time in Minutes | / |
| | Subject Device | Predicate Device | |
| Bleomycin Sulfate 15.0 mg/ml | Not tested | > 240 | Different |
| Busulfan 6.0 mg/ml | Not tested | > 240 | Different |
| Carboplatin 10.0 mg/ml | > 240 | > 240 | Same |
| Carmustine (BCNU), 3.3 mg/ml | 16.4 | 59.4 | Same |
| Chloroquine 50.0 mg/ml | Not tested | > 240 | Different |
| Cisplatin 1 mg/ml | > 240 | > 240 | Same |
| Cyclophosphamide 20 mg/ml | > 240 | > 240 | Same |
| Cyclosporin A 100.0 mg/ml | Not tested | > 240 | Different |
| Cytarabine 100.0 mg/ml | Not tested | > 240 | Different |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 | > 240 | Same |
| Daunorubicin 5.0 mg/ml | Not tested | > 240 | Different |
| Docetaxel 10.0 mg/ml | > 240 | > 240 | Same |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 | > 240 | Same |
| Epirubicin 2.0 mg/ml | > 240 | > 240 | Same |
| Etoposide (Toposar), 20.0 mg/ml | > 240 | > 240 | Same |
| Fludarabine 25.0 mg/ml | Not tested | > 240 | Different |
| Fluorouracil, 50.0 mg/ml | > 240 | > 240 | Same |
| Gemcitabine 38.0 mg/ml | > 240 | > 240 | Same |
| Idaribicin 1.0 mg/ml | Not tested | > 240 | Different |
| Ifosfamide 50.0 mg/ml | > 240 | > 240 | Same |
| Irinotecan 20.0 mg/ml | > 240 | > 240 | Same |
| Mechlorethamine HCl 1.0 mg/ml | Not tested | > 240 | Different |
| Melphalan 5 mg/ml | Not tested | > 240 | Different |
| Methotrexate 25 mg/ml | > 240 | > 240 | Same |
| Mitomycin C 0.5 mg/ml | > 240 | > 240 | Same |
| Mitoxantrone 2.0 mg/ml | > 240 | > 240 | Same |
| Oxaliplatin 2.0 mg/ml | > 240 | > 240 | Same |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 | > 240 | Same |
| Paraplatin 10 mg/ml | Not tested | > 240 | Different |
| Retrovir 10 mg/ml | Not tested | > 240 | Different |
| Rituximab 10 mg/ml | Not tested | > 240 | Different |
| Thiotepa, 10.0 mg/ml | 98.6 | 118.5 | Different |
| Topotecan HCl 1 mg/ml | Not tested | > 240 | Different |
| Trisonex 1 mg/ml | Not tested | > 240 | Different |
| Velcade (Bortezomib) 1 mg/ml | Not tested | > 240 | Different |
| Vincristine 1.0 mg/ml | > 240 | > 240 | Same |

#### Table1-Comparison of Subject and Predicate Devices

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#### 8.0 Summary of Non-Clinical Testing

### Biocompatibility Testing

The biocompatibility evaluation for Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs was conducted in accordance with the following standards:

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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

| Test Method | Purpose | Acceptance Criteria | Results |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| ISO 10993-10:2010<br>Tests For Irritation And<br>Skin Sensitization | To determine if device<br>is a skin irritant | The device must be a<br>non-irritant | Pass |
| ISO 10993-10:2010<br>Tests For Irritation And<br>Skin Sensitization | To determine if device<br>is a skin sensitizer | The device must be a<br>non- sensitizer | Pass |
| ISO 10993-5:2009<br>Tests For In Vitro<br>Cytotoxicity | To determine if the<br>device is potential<br>toxicity to L-929<br>cells. | The device must be a<br>non toxicity. | Pass |
| Test Method | Purpose | Acceptance Criteria | Results(2 mg/glove) |
| ASTM D6124-06<br>(Reapproved 2017)<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine residual<br>powder | ≤ 2 mg/glove | S:0.02<br>M:0.12<br>L:0.16<br>XL:0.14<br>Pass |
| ASTMD5151-19<br>Standard Test Method<br>for Detection of Holes<br>in Medical Gloves | To determine water<br>tightness | Meet the requirements<br>of ASTM D5151 AQL<br>2.5 | S:0/125 leaks |
| | | | M: 0/125 leaks |
| | | | L: 0/125 leaks |
| | | | XL: 0/125 leaks |
| | | | Pass |
| ASTM D5250-19<br>Standard Specification<br>for Poly (vinyl chloride)<br>Gloves for Medical<br>Application | To determine physical<br>dimensions | Length(mm):S:≥220. | Length(mm):>230 |
| | | M/L/XL: ≥230 | Width(mm): |
| | | Width(mm): | S: 88 |
| | | S: 80±10; | M: 98-99 |
| | | M: 95±10; | L: 110-112 |
| | | L: 110±10; | XL: 115-117 |
| | | XL: 120±10; | Pass |
| | | Thickness (mm): | Finger: 0.101-0.128 |
| | | Finger: ≥0.05 | Palm: 0.067-0.78 |
| | | Palm: ≥0.05 | Pass |
| | | | |
| ASTM D412-06a-2013<br>Standard Test Methods<br>for Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension | To determine physical<br>properties | Before Aging:<br>Tensile<br>Strength≥14MPa<br>Ultimate<br>Elongation≥500% | Before Aging:<br>Tensile Strength:<br>25.4 ~36.3 MPa<br>Ultimate Elongation:<br>508%~563% |
| | | After Aging:<br>Tensile<br>Strength≥14MPa<br>Ultimate<br>Elongation≥400% | After Aging:<br>Tensile Strength:<br>25.8~35.6 MPa<br>Ultimate Elongation:<br>483%~525%<br>Pass |
| | | | |
| | | | |

Table 2 Biocompatibility Testing

## 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 D 6978-05 (Reapproved 2019). Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

## Table 3 Non-Clinical 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, Nitrile Powder Free Examination Gloves,Tested For Use With

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Chemotherapy Drugs is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190736.