Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

K213040 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · LZA · Apr 27, 2022 · General Hospital

Device Facts

• Record ID: K213040
• Device Name: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
• Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 27, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Story

Single-use, non-sterile, powder-free nitrile examination gloves; available in blue, blue-violet, and black. Designed for use by healthcare examiners to prevent cross-contamination. Blue and blue-violet variants tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05; black variant tested for permeation resistance against Fentanyl Citrate. Gloves are worn on hands during clinical examinations. Output is a physical barrier protecting the examiner from patient fluids and specific hazardous chemical agents. Benefits include reduced risk of exposure to chemotherapy agents or Fentanyl Citrate during patient care.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (tensile strength, elongation), freedom from holes, residual powder content, and permeation testing per ASTM D6978-05. Biocompatibility testing performed per ISO 10993 series (irritation, sensitization, acute systemic toxicity).

Technological Characteristics

Material: Powder-free nitrile. Standards: ASTM D6319-19 (physical properties), ASTM D6978-05 (chemotherapy permeation), ASTM D5151-19 (freedom from holes). Dimensions: 220-230mm length, 0.05mm palm/0.11mm finger thickness. Non-sterile. Single-use. Colorants added for blue, blue-violet, and black variants.

Indications for Use

Indicated for use as a single-use, non-sterile, powder-free patient examination glove to prevent contamination between patient and examiner. Blue and blue-violet variants are indicated for use with specific chemotherapy drugs; black variant is indicated for use with Fentanyl Citrate.

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

• Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs (K211220)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

April 27, 2022

Guang Dong Kingfa Sci. & Tech.Co., Ltd. Xiaoge Yu Manager No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China

Re: K213040

Trade/Device Name: Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Colored Tested For Use With Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: April 16, 2022 Received: April 18, 2022

Dear Xiaoge Yu:

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.

Bifeng Qian, M.D., Ph.D Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K213040

Device Name

Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs

Indications for Use (Describe)

The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows:

- · Bleomycin Sulfate 15 mg/ml >240 min.
- · Carboplatin 10 mg/ml >240 min.
- · Carmustine (BCNU) 3.3 mg/ml 17.2 min.
- Cisplatin 1.0 mg/ml >240 min.
- · Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min.
- · Cytarabine HCI 100 mg/ml >240 min.
- · Dacarbazine (DTIC)10.0 mg/ml >240 min.
- Daunorubicin 5.0 mg/ml >240 min.
- · Docetaxel 10.0 mg/ml >240 min
- · Doxorubicin HCI 2.0 mg/ml >240 min.
- · Etoposide (Toposar) 20.0 mg/ml >240 min.
- Fluorouracil 50.0 mg/ml >240 min.
- Gemcitabine 38 mg/ml>240 min.
- · Idarubicin 1 mg/ml >240 min.
- Ifosfamide 50.0 mg/ml >240 min.
- Irinotecan 20.0 mg/ml >240 min.
- · Mechlorethamine HCI 1.0 mg/ml>240 min.
- · Melphalan 5 mg/ml >240 min.
- Methotrexate 25 mg/ml >240 min.
- · Mitromycin C. 0.5 mg/ml >240
- Mitoxantrone 2.0 mg/ml >240 min.
- · Paclitaxel (Taxol) 6.0 mg/ml >240 min.
- · Thiotepa 10.0 mg/ml 13.9 min.
- Vincristine Sulfate 1.0 mg/ml >240 min.

Warning: 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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K213040

#### Device Name

Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With Chemotheraoy Drues

Indications for Use (Describe)

The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The tested chemotherapy drug are as follows:

- · Carmustine (BCNU) 3.3 mg/ml 65.3 min.
- · Cisplatin 1.0 mg/ml >240 min.
- · Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min.
- · Dacarbazine (DTIC)10.0 mg/ml >240 min.
- · Doxorubicin HCI 2.0 mg/ml >240 min.
- · Etoposide (Toposar) 20.0 mg/ml >240 min.
- Fluorouracil 50.0 mg/ml >240 min.
- · Methotrexate 25 mg/ml >240 min.
- · Paclitaxel (Taxol) 6.0 mg/ml >240 min.
- · Thiotepa 10.0 mg/ml 58.3 min.、

Warning: 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K213040

Device Name

Nitrile Patient Examination Gloves Black Colored Tested For Use With Fentanyl Citrate

Indications for Use (Describe)

The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The Nitrile Patient Examination Gloves Black Colored were tested for use with Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. • Fentanyl Citrate 100mcg/2ml >240 minutes

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# 510(k) summary: K213040

## l. Submitter

GUANGDONG KINGFA SCI. & TECH.CO., LTD. No.28 Delong Ave., Shijiao Town, Qingcheng District, Qingyuan, Guangdong, China

Contact person: Xiaoge Yu Position: Manager Tel.: [phone] E-mail: [e-mail]

Preparation date: Apr. 27, 2022

# US Agent

Jeff Zhang Ucl-Reg Service Inc 602 Rockwood Rd Wilmington, DE US 19802 Phone: [phone] Email: [e-mail]

# II. Proposed Device

| Device Trade Name | Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With Chemotherapy Drugs Nitrile Patient Examination Gloves Black Colored Tested For Use With Fentanyl Citrate |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Patient Examination Glove (Tested For Use With Chemotherapy Drugs) |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA, LZC,OPJ, QDO |
| Review Panel | General Hospital |

# III. Predicate Devices

| 510(k) Number: | K211220 |
|----------------|-----------------------------------------------------------------------------------|
| Trade name: | Nitrile Patient Examination Gloves Blue Tested For Use With<br>Chemotherapy Drugs |

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| | Nitrile Patient Examination Gloves Blue Violet Tested For Use<br>With Chemotherapy Drugs |
|-----------------|------------------------------------------------------------------------------------------|
| Common name: | Patient Examination Glove |
| Classification: | Class I |
| Product Code: | LZA, LZC,OPJ |

### IV. Device description

Power-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in six sizes, x-small (6.5"), small (7"), medium (8"), large (8.5"), X-large (9"), XXL (9.5"). Three colors are available for all size, includes blue, blue violet and black.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

### V. Indication for use

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

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The Nitrile Patient Examination Gloves Blue Colored Tested Chemotherapy Drugs are as follows:

- Bleomycin Sulfate 15 mg/ml >240 min. .
- Carboplatin 10 mg/ml >240 min. ●
- Carmustine (BCNU) 3.3 mg/ml 17.2 min.
- Cisplatin 1.0 mg/ml >240 min.
- Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. ●
- Cytarabine HCI 100 mg/ml >240 min.
- . Dacarbazine (DTIC)10.0 mg/ml >240 min.
- Daunorubicin 5.0 mg/ml >240 min.
- Docetaxel 10.0 mg/ml >240 min .
- Doxorubicin HCI 2.0 mg/ml >240 min. ●
- Etoposide (Toposar) 20.0 mg/ml >240 min. ●

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- Fluorouracil 50.0 mg/ml >240 min. .
- Gemcitabine 38 mg/ml>240 min. ●
- ldarubicin 1 mg/ml >240 min. ●
- lfosfamide 50.0 mg/ml >240 min. ●
- Irinotecan 20.0 mg/ml >240 min. ●
- Mechlorethamine HCI 1.0 mg/ml>240 min. ●
- Melphalan 5 mg/ml >240 min.
- Methotrexate 25 mg/ml >240 min. .
- Mitromycin C. 0.5 mg/ml >240 .
- Mitoxantrone 2.0 mg/ml >240 min. .
- Paclitaxel (Taxol) 6.0 mg/ml >240 min. ●
- Thiotepa 10.0 mg/ml 13.9 min.
- Vincristine Sulfate 1.0 mg/ml >240 min .

Warning: Do not use with Carmustine and Thiotepa.

The Nitrile Patient Examination Gloves Blue Violet Colored Tested Chemotherapy Drugs as follows:

- Carmustine (BCNU) 3.3 mg/ml 65.3 min. ●
- Cisplatin 1.0 mg/ml >240 min. ●
- Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. ●
- Dacarbazine (DTIC)10.0 mg/ml >240 min. ●
- . Doxorubicin HCI 2.0 mg/ml >240 min.
- Etoposide (Toposar) 20.0 mg/ml >240 min.
- . Fluorouracil 50.0 mg/ml >240 min.
- . Methotrexate 25 mg/ml >240 min.
- . Paclitaxel (Taxol) 6.0 mg/ml >240 min.
- . Thiotepa 10.0 mg/ml 58.3 min.

Warning: Do not use with Carmustine and Thiotepa.

The Nitrile Patient Examination Gloves Black Colored Tested with Fentanyl Citrate

- Fentanyl Citrate 100mcg/2ml >240 minutes .
# VI. Comparison of technological characteristics with the predicate devices

#### Proposed device Predicate device ltem Discussion (K213040) (K211220)

## Table 1 Comparison of Natural Rubber Surgical Gloves

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| Product name | Nitrile Patient<br>Examination Gloves<br>Blue Colored Tested For<br>Use With Chemotherapy<br>Drugs.<br>Nitrile Patient<br>Examination Gloves<br>Blue Violet Colored<br>Tested For Use With<br>Chemotherapy Drugs.<br>Nitrile Patient<br>Examination Gloves<br>Black Colored Tested<br>For Use With Fentanyl<br>Citrate | Nitrile Patient<br>Examination Gloves Blue<br>Tested For Use With<br>Chemotherapy Drugs<br>Nitrile Patient<br>Examination Gloves Blue<br>Violet Tested For Use<br>With Chemotherapy<br>Drugs | - | Color | Blue, Blue violet, Black | Blue, Blue violet | Similar2 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Product Code | LZA, LZC,OPJ, QDO | LZA, LZC,OPJ | Similar | Size | x-small, small, medium,<br>large, x-large, XX-large | small, medium, large,<br>x-large | Similar |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | Dimensions –<br>Length | Complies with ASTM<br>D6319-19<br>XS (220mm min)<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min)<br>XXL (230mm min) | Complies with ASTM<br>D6319-19<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min) | Same |
| Classification | Class I | Class I | Same | Dimensions –<br>Width | Complies with ASTM<br>D6319-19)<br>XS (70 $\pm$ 10mm)<br>S (80 $\pm$ 10mm)<br>M (95 $\pm$ 10mm)<br>L (110 $\pm$ 10mm)<br>XL (120 $\pm$ 10mm)<br>XXL ( $\ge$ 120mm) | Complies with ASTM<br>D6319-19<br>S (80 $\pm$ 10mm)<br>M (95 $\pm$ 10mm)<br>L (110 $\pm$ 10mm)<br>XL (120 $\pm$ 10mm) | Similar |
| Powder free | Yes | Yes | Same | Dimensions –<br>Thickness | Complies with:<br>ASTM D6319-19<br>Palm: 0.05mm min<br>Finger: 0.11mm min | Complies with:<br>ASTM D6319-19<br>Palm: 0.05mm min<br>Finger: 0.11mm min | Same |
| Indication for use | The nitrile examination<br>glove is intended to be<br>worn on the hands of<br>examiner's to prevent<br>contamination between<br>patient and examiner.<br>This is a single-use,<br>powder-free, non-sterile<br>device.<br>These gloves were<br>tested for use with<br>chemotherapy drugs per<br>ASTM D6978-05<br>(Reapproved 2019)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested<br>for use with<br>chemotherapy drugs as<br>per ASTM D6978-05<br>(Reapproved 2019)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs | Similar | Physical<br>Properties | Complies with:<br>ASTM D6319-19<br>minimum:<br>Tensile Strength:<br>Before Aging $\ge$ 14 MPa, min.<br>After Aging $\ge$ 14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Complies with:<br>ASTM D6319-19<br>minimum:<br>Tensile Strength:<br>Before Aging $\ge$ 14 MPa, min.<br>After Aging $\ge$ 14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Same |
| Main Material | Powder-Free Nitrile | Powder-Free Nitrile | Same | Freedom from<br>Holes | Complies with ASTM<br>D6319-19 and ASTM<br>D5151-19 G-1, AQL 1.5 | Complies with ASTM<br>D6319-19 and ASTM<br>D5151-19 G-1, AQL 1.5 | Same |
| Residual<br>Powder | Complies with:<br>ASTM D6319-19 | Complies with:<br>ASTM D6319-19 | Same | | | | |

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| | <2mg per glove<br>Limited <24 hours | <2mg per glove<br>Limited <24 hours | |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Contact<br>Durations | | | Same |
| Biocompatibility | ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>At the neat extraction, the<br>test article is<br>considered cytotoxic, but<br>the acute systemic<br>toxicity results<br>demonstrate the device<br>will not cause a systemic<br>effect. | ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>At the neat extraction, the<br>test article is considered<br>cytotoxic, but the acute<br>systemic toxicity results<br>demonstrate the device<br>will not cause a systemic<br>effect. | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Rx Only or OTC | Over the Counter | Over the Counter | Same |
| Chemotherapy<br>Drugs | Nitrile Patient<br>Examination Gloves<br>Blue Colored Tested For<br>Use With Chemotherapy<br>Drugs | Nitrile Patient<br>Examination Gloves Blue<br>Tested For Use With<br>Chemotherapy Drugs | / |
| | Bleomycin Sulfate 15<br>mg/ml >240 min. | NA | Similar¹ |
| | Carboplatin 10<br>mg/ml >240 min. | NA | |
| | Carmustine (BCNU) 3.3<br>mg/ml 17.2 min. | Carmustine (BCNU) 3.3<br>mg/ml 65.3 min. | |
| | Cisplatin 1.0 mg/ml >240<br>min. | Cisplatin 1.0 mg/ml >240<br>min. | |
| | Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 min. | Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 min. | |
| | Cytarabine HCI 100<br>mg/ml >240 min. | NA | |
| | Dacarbazine (DTIC)10.0<br>mg/ml >240 min. | Dacarbazine (DTIC)10.0<br>mg/ml >240 min. | |
| | Daunorubicin 5.0<br>mg/ml >240 min. | NA | |
| | Docetaxel 10.0 mg/ml | NA | |
| >240 min | | | |
| Doxorubicin HCI 2.0<br>mg/ml >240 min. | Doxorubicin<br>Hydrochloride 2.0<br>mg/ml >240 min. | | |
| Etoposide (Toposar) 20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0<br>mg/ml >240 min. | | |
| Fluorouracil 50.0<br>mg/ml >240 min. | Fluorouracil 50.0<br>mg/ml >240 min. | | |
| Gemcitabine 38<br>mg/ml>240 min. | NA | | |
| Idarubicin 1 mg/ml >240 min. | NA | | |
| Ifosfamide 50.0<br>mg/ml >240 min. | NA | | |
| Irinotecan 20.0 mg/ml<br>>240 min. | NA | | |
| Mechlorethamine HCI<br>1.0 mg/ml>240 min. | NA | | |
| Melphalan 5 mg/ml >240 min. | NA | | |
| Methotrexate 25<br>mg/ml >240 min. | NA | | |
| Mitromycin C. 0.5<br>mg/ml >240 | NA | | |
| Mitoxantrone 2.0 mg/ml<br>>240 min. | NA | | |
| Paclitaxel (Taxol) 6.0<br>mg/ml >240 min. | Paclitaxel (Taxol) 6.0<br>mg/ml >240 min. | | |
| Thiotepa 10.0 mg/ml<br>13.9 min. | Thiotepa 10.0 mg/ml<br>58.3min. | | |
| Vincristine Sulfate 1.0<br>mg/ml >240 min. | NA | | |
| Nitrile Patient<br>Examination Gloves Blue<br>Violet Colored Tested For Use<br>Chemotherapy Drugs | Nitrile Patient<br>Examination Gloves Blue<br>Violet Tested For Use With<br>Chemotherapy Drugs | / | |
| Carmustine (BCNU) 3.3<br>mg/ml 65.3 min. | Carmustine (BCNU) 3.3<br>mg/ml 65.3 min. | Similar¹ | |
| Cisplatin 1.0 mg/ml >240 min. | Cisplatin 1.0 mg/ml >240 min. | | |
| Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml >240 min. | Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml >240 min. | | |
| Dacarbazine (DTIC)10.0 mg/ml >240 min. | Dacarbazine (DTIC)10.0 mg/ml >240 min. | | |
| Doxorubicin<br>Hydrochloride 2.0 mg/ml >240 min. | Doxorubicin<br>Hydrochloride 2.0 mg/ml >240 min. | | |
| Etoposide (Toposar)<br>20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0 mg/ml >240 min. | | |
| Fluorouracil 50.0 mg/ml >240 min. | Fluorouracil 50.0 mg/ml >240 min. | | |
| Methotrexate 25 mg/ml >240 min. | NA | | |
| Doxorubicin<br>Hydrochloride 2.0 mg/ml >240 min. | Doxorubicin<br>Hydrochloride 2.0 mg/ml >240 min. | | |
| Etoposide (Toposar)<br>20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0 mg/ml >240 min. | | |
| Nitrile Patient /<br>Examination Gloves<br>Black Colored Tested<br>with Fentanyl Citrate | | New add<br>black color<br>glove2 | |
| • Fentanyl Citrate<br>100mcg/2ml >240<br>minutes | NA | | |

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1 Add new 15 kinds of the chemotherapy label claim to the blue colored glove and add one chemotherapy drug test to the blue violet colored glove, which the both of glove has got the clearance under K211220. The permeation testing was conducted per ASTM D6978-05 (Reapproved 2019) to support the addition of the labeling claim.

2 Add a new model glove with black and label claim the device tested by Fentanyl Citrate. Only change the colorant additives during manufacturing. The biocompatibility testing has been conduct on the black gloves and the test results prove the black glove is biologically safe as the previous device. In addition, the physical performances of the proposed device were performed on the final device per ASTM D6319-19.

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# VII. Non-Clinical Testing

Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.

| Items | Methodology /<br>Standard | Acceptance Criteria | Results |
|------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Palm width | ASTM D3767-03(2020) | XS (70±10mm)<br>S (80±10mm)<br>M (95±10mm)<br>L (110±10mm)<br>XL (120±10mm)<br>XXL ( $\ge$ 120mm) | Pass |
| Length | ASTM D3767-03(2020) | XS (220mm min)<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min)<br>XXL (230mm min) | Pass |
| Thickness | ASTM D3767-03(2020) | Finger: 0.11mm<br>Palm: 0.05mm | Pass |
| Freedom<br>from holes | ASTM D5151-19 | Freedom free hole<br>AQL 2.5 | Pass |
| Physical Properties (before aging) | | | |
| Tensile<br>Strength | ASTM D412-16 | $\ge$ 14Mpa | Pass |
| Ultimate<br>Elongation | ASTM D412-16 | $\ge$ 500% | Pass |
| Physical Properties (after aging) | | | |
| Tensile<br>Strength | ASTM D573-04(2019) | $\ge$ 14Mpa | |
| Ultimate<br>Elongation | ASTM D573-04(2019) | $\ge$ 400% | Pass |
| Residual<br>Powder<br>Content | ASTM D6124-06(2017) | ≤2mg per glove | Pass |
| Cytotoxic | ISO 10993-5 | Non-cytotoxic | Under<br>conditions of the<br>study, device |
| | | | extract is cytotoxic. |
| Acute Systemic<br>Toxicity | ISO 10993-11 | Non-acute systemic<br>toxicity | Under conditions of<br>the study, did not show acute<br>systemic toxicity<br>in vivo / Pass |
| Irritation | ISO 10993-10 | Non-irritating | Under the<br>conditions of the<br>study, not an<br>irritant/ Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Under<br>conditions of the<br>study, not a<br>sensitizer./ Pass |

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# VIII. Clinical Testing

No clinical study is included in this submission.

# IX. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Power-Free Nitrile 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 in K211220.