Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the summary describes its physical and chemical resistance properties, not any computational or analytical functions.

Therapeutic

No.
Explanation: The device, a nitrile examination glove, is intended for barrier protection between patient and examiner, primarily to prevent contamination and for use during examination. It does not provide any therapeutic effect to the patient.

Diagnostic

No

This device is a medical glove intended to prevent contamination, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical product (nitrile examination gloves) and the summary describes its physical properties and testing, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as "to be worn on the hands of examination between patient and examiner" for the purpose of preventing contamination. This is a barrier device, not a device used to perform tests on samples taken from the human body to diagnose diseases or conditions.
Device Description: The description reinforces that it's a glove for examination purposes.
Performance Studies: The performance studies focus on physical properties, freedom from defects, biocompatibility, and resistance to chemotherapy drugs. These are relevant to the protective function of a glove, not to diagnostic testing.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.

The testing for chemotherapy drug permeation is related to the protective function of the glove in a medical setting where such drugs might be handled, but it does not make the glove an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 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. Busulfan 6 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 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCI 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 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. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 13.9min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes

Warning: Do not use with Carmustine and Thiotepa.

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: Bleomycin Sulfate 15 mg/ml >240 min. Busulfan 6 mg/ml >240 min. Carboplatin 10 mg/ml >240 min. Carmustine (BCNU) 3.3 mg/ml 65.3 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 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCl 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 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. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 58.3min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes

Warning: Do not use with Carmustine and Thiotepa.

The Nitrile Patient Examination Gloves Black 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 49.2 min. Cisplatin 1.0 mq/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. Fentanyl Citrate 100mcg/2ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 87.1min.

Warning: Do not use with Carmustine and Thiotepa.

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC, OPJ, ODO

Device Description

Powder-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, extra-small, medium, large, extralarge, extra-extra-large. Three colors are available for all size, includes blue, blue violet and black.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were leveraged from the predicate submission. Additional testing per ASTM D6978-05 (2019) was performed to support inclusion of additional chemotherapy drugs to the indications for use.

Test Methodology: ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11.
Results: All tests Passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K213040

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

October 7, 2022

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

Re: K222714

Trade/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 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: August 30, 2022 Received: September 8, 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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222714

Device Name

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

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 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. Busulfan 6 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 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCI 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 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. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 13.9min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes

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.

3

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."

4

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222714

Device Name

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

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: Bleomycin Sulfate 15 mg/ml >240 min. Busulfan 6 mg/ml >240 min. Carboplatin 10 mg/ml >240 min. Carmustine (BCNU) 3.3 mg/ml 65.3 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 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCl 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 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. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 58.3min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes

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.

5

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."

6

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222714

Device Name

Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

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 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 49.2 min. Cisplatin 1.0 mq/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. Fentanyl Citrate 100mcg/2ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 87.1min.

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."

7

510(k) Summary – K222714

l. Submitter

GUANG DONG KINGFA SCI. & TECH.CO., LTD. No. 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province 511545, China

Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn

Preparation date: August. 30, 2022

II. Proposed Device

| Device Trade 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 |
| 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:	K213040
Trade 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
Common name:	Patient Examination Glove
Classification:	Class I

8

Product Code: LZA, LZC,OPJ, QDO

IV. Device description

Powder-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, extra-small, medium, large, extralarge, extra-extra-large. Three colors are available for all size, includes blue, blue violet and black.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 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 Tested Chemotherapy Drugs are as follows:

Bleomycin Sulfate 15 mg/ml >240 min. .
Busulfan 6 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 mg/mL>240 min. .
Docetaxel 10.0 mg/ml >240 min .
Doxorubicin HCI 2.0 mg/ml >240 min. .
Epirubicin HCI 2.0 mg/ml >240 min. .
Etoposide (Toposar) 20.0 mg/ml >240 min. .

9

K222714

Fludarabine 25.0 mg/ml >240 min. .
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 HCl 1.0 mq/ml>240 min. .
Melphalan 5 mg/ml >240 min. .
Methotrexate 25 mq/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. .
Rituximab 10.0 mg/ml >240 min. .
Thiotepa 10.0 mq/ml 13.9min. .
Trisenox 1.0 mg/ml >240 min. .
Vincristine Sulfate 1.0 mg/ml >240 min. .
Fentanyl Citrate 100mcg/2ml >240 minutes .

Warning: Do not use with Carmustine and Thiotepa.

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

Bleomycin Sulfate 15 mg/ml >240 min. .
Busulfan 6 mg/ml >240 min. .
Carboplatin 10 mg/ml >240 min. .
Carmustine (BCNU) 3.3 mg/ml 65.3 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 mq/mL>240 min. .
Docetaxel 10.0 mg/ml >240 min .
Doxorubicin HCI 2.0 mg/ml >240 min. .
Epirubicin HCI 2.0 mg/ml >240 min. .
Etoposide (Toposar) 20.0 mg/ml >240 min. .

10

Fludarabine 25.0 mg/ml >240 min. .
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 mq/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. .
Rituximab 10.0 mg/ml >240 min. .
Thiotepa 10.0 mg/ml 58.3min. .
Trisenox 1.0 mg/ml >240 min. .
Vincristine Sulfate 1.0 mg/ml >240 min. .
Fentanyl Citrate 100mcg/2ml >240 minutes .

Warning: Do not use with Carmustine and Thiotepa.

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

Carmustine (BCNU) 3.3 mg/ml 49.2 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. .
Fentanyl Citrate 100mcg/2ml >240 minutes .
Paclitaxel (Taxol) 6.0 mg/ml >240 min. .
Thiotepa 10.0 mg/ml 87.1min. .

Warning: Do not use with Carmustine and Thiotepa.

11

VI. Comparison of technological characteristics with the predicate devices

Item	Proposed device (K222714)	Predicate device (K213040)	Discussion
Product 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.	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.	-
Product Code	LZA, LZC,OPJ, QDO	LZA, LZC,OPJ, QDO	Same
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	Same
Classification	Class I	Class I	Same
Powder free	Yes	Yes	Same
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 and Fentanyl Citrate as per ASTM D6978-05	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 and Fentanyl Citrate as per ASTM D6978-05	Same

	(Reapproved 2013)
Standard Practice for
Assessment of Medical
Gloves to Permeation by
Chemotherapy Drugs	(Reapproved 2013)
Standard Practice for
Assessment of Medical
Gloves to Permeation by
Chemotherapy Drugs
Main Material	Powder-Free Nitrile	Powder-Free Nitrile	Same
Color	Blue, Blue violet, Black	Blue, Blue violet, Black	Same
Size	x-small, small, medium,
large, x-large, XX-large	x-small, small, medium,
large, x-large, XX-large	Same
Dimensions –
Length	Complies with ASTM
D6319-10
XS (220mm min)
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min)
XXL (230mm min)	Complies with ASTM
D6319-10
XS (220mm min)
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min)
XXL (230mm min)	Same
Dimensions –
Width	Complies with ASTM
D6319-10
XS (70±10mm)
S (80±10mm)
M (95±10mm)
L (110±10mm)
XL (120±10mm)
XXL (≥120mm)	Complies with ASTM
D6319-10
XS (70±10mm)
S (80±10mm)
M (95±10mm)
L (110±10mm)
XL (120±10mm)
XXL (≥120mm)	Same
Dimensions –
Thickness	Complies with:
ASTM D6319-10
Palm: 0.05mm min
Finger: 0.11mm min	Complies with:
ASTM D6319-10
Palm: 0.05mm min
Finger: 0.11mm min	Same
Physical
Properties	Complies with:
ASTM D6319-10
minimum:
Tensile Strength:
Before Aging ≥14 MPa,
min.
After Aging ≥14 MPa,
min.
Elongation:	Complies with:
ASTM D6319-10
minimum:
Tensile Strength:
Before Aging ≥14 MPa,
min.
After Aging ≥14 MPa,
min.
Elongation:	Same
	After Aging 400%, min.	After Aging 400%, min.
Freedom from
Holes	Complies with ASTM
D6319-10 and ASTM
D5151-06 G-1, AQL 1.5	Complies with ASTM
D6319-10 and ASTM
D5151-06 G-1, AQL 1.5	Same
Residual
Powder	Complies with:
ASTM D6319-10
240 min.
Busulfan 6 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	Nitrile Patient
Examination Gloves
Blue Colored
Tested For Use With
Chemotherapy Drugs
Bleomycin Sulfate 15
mg/ml >240 min.
NA
Carboplatin 10
mg/ml >240 min.
Carmustine (BCNU) 3.3
mg/ml 17.2 min.
Cisplatin 1.0 mg/ml >240
min	/
Similar¹

Table 1 Comparison of Nitrile Examination Gloves

12

13

14

| Cyclophosphamide
(Cytoxan) 20.0
mg/ml >240 min. | Cyclophosphamide
(Cytoxan) 20.0
mg/ml >240 min. | |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------|
| Cytarabine HCI 100
mg/ml >240 min. | Cytarabine HCI 100
mg/ml >240 min. | |
| Dacarbazine (DTIC)10.0
mg/ml >240 min. | Dacarbazine (DTIC)10.0
mg/ml >240 min. | |
| Daunorubicin 5
mg/mL>240 min. | Daunorubicin 5
mg/mL>240 min. | |
| Docetaxel 10.0 mg/ml

240 min 240 min | Doxorubicin HCI 2.0
mg/ml >240 min. mg/ml >240 min. | Epirubicin HCI 2.0
mg/ml >240 min. | Etoposide (Toposar)
20.0 mg/ml >240 min. mg/ml >240 min. | Fludarabine 25.0
mg/ml >240 min. | Fluorouracil 50.0
mg/ml >240 min. mg/ml >240 min. | Gemcitabine 38
mg/ml>240 min. mg/ml>240 min. | Idarubicin 1 mg/ml >240
min. min. | Ifosfamide 50.0
mg/ml >240 min. mg/ml >240 min. | Irinotecan 20.0 mg/ml
240 min. 240 min. | Mechlorethamine HCI
1.0 mg/ml>240 min. mg/ml>240 min. | Melphalan 5 mg/ml >240
min. min. | Methotrexate 25
mg/ml >240 min. mg/ml >240 min. | Mitromycin C. 0.5
mg/ml >240 mg/ml >240 | Mitoxantrone 2.0 mg/ml | | >240 min. | Paclitaxel (Taxol) 6.0
mg/ml >240 min. mg/ml >240 min. | Rituximab 10.0
mg/ml >240 min. | Thiotepa 10.0 mg/ml
58.3min. 58.3min. | Trisenox 1.0 mg/ml >240
min. | Vincristine Sulfate 1.0
mg/ml >240 min. mg/ml >240 min. | Fentanyl Citrate
100mcg/2ml >240
minutes | Nitrile Patient
Examination Gloves
Blue Violet Colored
Tested For Use With
Chemotherapy Examination Gloves
Blue Violet Colored
Tested For Use With
Chemotherapy Drugs | / |
| Bleomycin Sulfate 15
mg/ml >240 min. | Busulfan 6 mg/ml >240
min. | Carboplatin 10
mg/ml >240 min. | Carmustine (BCNU) 3.3
mg/ml 65.3 min. mg/ml 65.3 min. | Cisplatin 1.0
mg/ml >240 min. min. | Cyclophosphamide
(Cytoxan) 20.0
mg/ml >240 min. (Cytoxan) 20.0
mg/ml >240 min. | Cytarabine HCI 100
mg/ml >240 min. | Dacarbazine (DTIC)10.0
mg/ml >240 min. mg/ml >240 min. | Daunorubicin 5
mg/ml >240 min. | Docetaxel 10.0 mg/ml
240 min | Doxorubicin HCI 2.0
mg/ml >240 min. mg/ml >240 min. | Epirubicin HCI 2.0
mg/ml >240 min. | Etoposide (Toposar)
20.0 mg/ml >240 min. mg/ml >240 min. | Fludarabine 25.0
mg/ml >240 min. | Fluorouracil 50.0
mg/ml >240 min. 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. 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. mg/ml >240 min. | Rituximab 10.0
mg/ml >240 min. | Thiotepa 10.0 mg/ml
58.3min. 58.3min. | Trisenox 1.0 mg/ml >240
min. | Vincristine Sulfate 1.0
mg/ml >240 min. | Fentanyl Citrate
100mcg/2ml >240 minutes | Nitrile Patient
Examination Gloves
Black Colored
Tested For Use With
Chemotherapy Drugs Examination Gloves
Blue Violet Colored
Tested For Use With
Chemotherapy Drugs | / |
| Cisplatin 1.0
mg/mL>240 min. | Carmustine (BCNU) 3.3
mg/ml 49.2 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. | Paclitaxel (Taxol) 6.0
mg/ml >240 min. | Thiotepa 10.0 mg/ml
87.1min. | Fentanyl Citrate
100mcg/2ml >240
minutes 100mcg/2ml >240
minutes | Docetaxel 10.0 mg/ml
| |
| Doxorubicin HCI 2.0
| |
| NA | |
| Etoposide (Toposar) 20.0
| |
| NA | |
| Fluorouracil 50.0
| |
| Gemcitabine 38
| |
| Idarubicin 1 mg/ml >240
| |
| Ifosfamide 50.0
| |
| Irinotecan 20.0 mg/ml
| |
| Mechlorethamine HCI 1.0
| |
| Melphalan 5 mg/ml >240
| |
| Methotrexate 25
| |
| Mitromycin C. 0.5
| |
| Mitoxantrone 2.0 mg/ml | |
| | |
| >240 min. | |
| Paclitaxel (Taxol) 6.0
| |
| NA | |
| Thiotepa 10.0 mg/ml
| |
| NA | |
| Vincristine Sulfate 1.0
| |
| NA | |
Drugs | Nitrile Patient
| NA | Similar¹ |
| NA | |
| NA | |
| Carmustine (BCNU) 3.3
| |
| Cisplatin 1.0 mg/ml >240
| |
| Cyclophosphamide
| |
| NA | |
| Dacarbazine (DTIC)10.0
| |
| NA | |
| NA | |
| Doxorubicin HCI 2.0
| |
| NA | |
| Etoposide (Toposar) 20.0
| |
| NA | |
| Fluorouracil 50.0
| |
| NA | |
| NA | |
| NA | |
| NA | |
| NA | |
| NA | |
| Methotrexate 25
| |
| NA | |
| NA | |
| Paclitaxel (Taxol) 6.0
| |
| NA | |
| Thiotepa 10.0 mg/ml
| |
| NA | |
| NA | |
| NA | |
| Nitrile Patient
| NA | Similar¹ |
| NA | |
| NA | |
| NA | |
| NA | |
| NA | |
| NA | |
| NA | |
| NA | |
| Fentanyl Citrate
| |

15

16

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1 Add new kinds of the chemotherapy label claim to the previous cleared under K213040. The permeation testing was conducted per ASTM D6978-05 (Reapproved 2019) to support the addition of the labeling claim.

VII. Non-Clinical Testing

Non-clinical tests were leveraged from the predicate submission. Additional testing per

18

ASTM D6978-05 (2019) was performed to support inclusion of additional chemotherapy drugs to the indications for use.

Test Methodology	Purpose	Acceptance Criteria
ASTM D6319	Physical
Dimensions Test	Extra-Small:
Length: ≥ 220mm Width: 70±10 mm;
Small:
Length: ≥ 220mm Width: 80±10mm;
Medium:
Length: ≥ 230mm Width: 95±10mm
Large:
Length: ≥ 230mm Width: 110±10mm
Extra- Large:
Length: ≥ 230mm Width: 120±10mm
Extra- Extra- Large:
Length: ≥ 230mm Width: ≥120mm	Pass
		Thickness (mm):
Finger:≥0.05
Palm: ≥0.08	Pass
	Physical
properties	Before
Aging
		Tensile
Strength	≥14MPa	Pass
		Ultimate
Elongation	≥500%
		After
Aging
		Tensile
Strength	≥14MPa	Pass
		Ultimate
Elongation	≥500%
ASTM D5151	Freedom from
pinholes	Meet the requirements of ASTM
D5151Test for AQL 2.5	Pass
ASTM D6124	Powder Residue	Meet the requirements of ASTM
D6124