Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

K231643 · Syntex Healthcare Products Co., Ltd. · LZA · Sep 8, 2023 · General Hospital

Device Facts

• Record ID: K231643
• Device Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
• Applicant: Syntex Healthcare Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; intended for medical use to prevent cross-contamination between patient and examiner. Device provides a barrier against specific chemotherapy drugs and Fentanyl Citrate; tested per ASTM D6978-05(2019). Available in multiple sizes (XS-XXL). Used in clinical settings by healthcare professionals. Provides protection during handling of hazardous drugs; breakthrough times vary by agent. Warning issued for specific drugs (Carmustine, Thio Tepa) due to low permeation resistance.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (physical dimensions, tensile strength, elongation, water leak, powder residue), ASTM D6978-05(2019) (chemotherapy permeation), and ISO 10993 series (biocompatibility: cytotoxicity, acute systemic toxicity, dermal sensitization, primary skin irritation).

Technological Characteristics

Material: Nitrile. Form: Powder-free, blue, ambidextrous, non-sterile. Dimensions: Length 220-230mm, thickness min 0.05mm. Standards: ASTM D6319-19, ASTM D6978-05(2019), ASTM D412-16, ASTM D5151-19, ASTM D6124-06, ISO 10993-5/10/11/23, ISO 11737-1. Biodegradable property tested per ASTM D5511.

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs and Fentanyl Citrate. Warning: Do not use with Carmustine and Thio Tepa.

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

• Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K200581)

Reference Devices

• Powder Free Nitrile Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

September 8, 2023

Syntex Healthcare Products Co., Ltd. % Kathy Liu Project Manager Hongray(USA) Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710

Re: K231643

Trade/Device Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: June 5, 2023 Received: August 7, 2023

Dear Kathy Liu:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Allan Guan -S

For Bifeng Oian, M.D., 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K231643

#### Device Name

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

#### Indications for Use (Describe)

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

| Chemotherapy Drug | Minimum BDT (Minutes) |
|--------------------------------------------------|-----------------------|
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 12.9 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 35.6 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate (Oncovin), 1mg/ml (1,000ppm) | >240 |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 |

{3}------------------------------------------------

| Fentanyl Citrate | Minimum BDT Minutes |
|----------------------------|---------------------|
| Fentanyl Citrate Injection | (100 mcg/2ml) >240 |

*Please note that the following drugs have extremely low permeation times:

Carmustine: 12.9 minutes, Thio Tepa: 35.6 minutes

Warning: Do not use with Carmustine and Thio Tepa.

Type of Use (Select one or both, as applicable)

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."

{4}------------------------------------------------

No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China

## 510K Summary K231643

Date Prepared: September 07, 2023

#### 1. Owner's Identification:

Mr. Qiao Zhiqiang Syntex Healthcare Products Co., Ltd No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China Tel:[phone] Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel:[phone] Email: fdareg(@)hongray.com.cn or janicema(@hongrayusa.com

#### 2. Name of the Device:

Trade / Product Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, OPJ, QDO Classification Panel: General Hospital Device Class: Class I

#### 3. Predicate Device Information:

Primary Predicate Device: Hartalega NGC SDN. BHD. Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K200581)

Reference Device: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269)

#### 4. Device Description:

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.

#### 5. Indications for Use:

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent

{5}------------------------------------------------

No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China

## 510K Summary K231643

contamination between patient and examiner.

Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

| Chemotherapy Drug | Minimum Breakthrough Detection Time (Minutes) |
|--------------------------------------------------|-----------------------------------------------|
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 12.9 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 35.6 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate (Oncovin), 1mg/ml (1,000ppm) | >240 |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 |

{6}------------------------------------------------

No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China

## 510K Summary K231643

| Fentanyl Citrate | Minimum Breakthrough Detection Time (Minutes) |
|------------------------------------------|-----------------------------------------------|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |

*Please note that the following drugs have extremely low permeation times:

Carmustine: 12.9 minutes, Thio Tepa: 35.6 minutes

Warning: Do not use with Carmustine and Thio Tepa.

#### 6. Comparison of Subject Device and Predicate Devices:

The following tables are summaries of the technological characteristics, biocompatibility and testing for the subject Device and predicate devices.

General Comparison Table:

| | Subject Device<br>K231643 | Predicate Device<br>K200581 | Reference Device<br>K221269 | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Trade Name | Biodegradable Nitrile<br>Powder Free Examination<br>Gloves Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate(Blue) | Biodegradable Nitrile<br>Powder Free Examination<br>Gloves Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate (Blue) | Powder Free Nitrile<br>Examination Glove<br>(Blue) Tested for Use<br>with Chemotherapy<br>Drugs and Fentanyl<br>Citrate | Similar |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC,QDO | LZA, LZC,QDO | Different* |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Indications for<br>Use | Biodegradable Nitrile<br>Powder Free Examination<br>Gloves Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate (Blue) is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner.<br>Gloves have been tested for<br>use with chemotherapy drugs<br>and Fentanyl Citrate using<br>ASTM D6978-05(2019) | Biodegradable Nitrile<br>Powder Free Examination Gloves<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate (Blue) is a<br>patient medical exam glove<br>which is a disposable device<br>intended for medical purpose<br>that is worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>examiner and patient.<br>It is also tested to be used<br>against chemotherapy drugs<br>and Fentanyl Citrate | The device is a<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner.<br>These gloves were tested<br>for use with<br>chemotherapy drugs and<br>Fentanyl listed on the<br>label. | Same as<br>K200581 |
| Material | Nitrile | Nitrile | Nitrile | Same |

{7}------------------------------------------------

No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China

## 510K Summary K231643

| Powder or<br>Powder Free | Powder Free | Powder Free | Powder Free | Same |
|--------------------------------------------------------|-------------------------------|----------------------------|-------------------------------|--------------------|
| Color | Blue | Blue | Blue | Same |
| Single use | Single use | Single use | Single use | Same |
| Chemotherapy<br>Drugs and<br>Fentanyl Citrate<br>Claim | See below comparison<br>table | See below comparison table | See below comparison<br>table | / |
| Biodegradation<br>Properties | Biodegradable | Biodegradable | / | Same as<br>K200581 |

* QDO and OPJ, both designated for Medical Gloves with Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs, the subject device added the product code OPJ as per requirements but does not raise questions of safety and effectiveness.

Technological Characteristic Comparison Table:

| Technological<br>Characteristics | Subject<br>Device<br>K231643 | Predicate Device<br>K200581 | Reference Device<br>K221269 | Comparison |
|----------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------|
| Physical Dimension | | | | |
| Length | Minimum 220mm for<br>sizes XS and S,<br>230mm for size M-<br>XXL | Minimum 220mm for<br>sizes XS and S,<br>230mm for size M-<br>XXL | Minimum 220mm<br>for sizes XS and S,<br>230mm for size M-<br>XXL | Same |
| Palm Width (size) (mm) | | | | |
| XS | 70±10 | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | 120±10 | Same |
| XXL | 130±10 | 130±10 | 130±10 | Same |
| Thickness(mm) | | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Physical Property | | | | |
| Tensile Strength, Before<br>Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,<br>Before Aging | 500%, min | 500%, min | 500%, min | Same |
| Tensile Strength, After<br>Accelerated Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |

{8}------------------------------------------------

No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China

## 510K Summary K231643

| Ultimate Elongation, After<br>Accelerated Aging | 400%, min | 400%, min | 400%, min | Same |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------|
| Watertight (1000ml) | G-I, AQL2.5 | G-I, AQL2.5 | G-I, AQL2.5 | Same |
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| In vitro Cytotoxicity<br>ISO 10993-5 | The test article extract<br>showed potential<br>toxicity to L929 cells. | N/A | The test article<br>extract showed<br>potential toxicity to<br>L929 cells. | Same as<br>K221269 |
| Acute Systemic Toxicity Test<br>ISO 10993-11 | Under the conditions of<br>this study, the device<br>showed no evidence of<br>acute systemic toxicity | Under the conditions<br>of this study, the<br>device showed no<br>evidence of acute<br>systemic toxicity | Under the<br>conditions of this<br>study, the device<br>showed no evidence<br>of acute systemic<br>toxicity | Same |
| Dermal Sensitization<br>ISO 10993-10 | Under the conditions<br>of the study, the device<br>is not a sensitizer | Under the conditions<br>of the study, the device<br>is not a sensitizer | Under the<br>conditions of the<br>study, the device is<br>not a sensitizer | Same |
| Primary Skin Irritation<br>ISO 10993-23 | Under the conditions of the study, the device is<br>not an irritant | Under the conditions<br>of the study, the device<br>is not an irritant | Under the<br>conditions of the<br>study, the device<br>is not an irritant | Same |

Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:

| Tested Chemotherapy Drug and<br>Concentration | Minimum Breakthrough Detection Time<br>(Minutes) | | | Comparison |
|-----------------------------------------------------|--------------------------------------------------|-----------------------------|-----------------------------|--------------------|
| | Subject Device<br>K231643 | Predicate Device<br>K200581 | Reference Device<br>K221269 | |
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 | >240 | / | Same as<br>K200581 |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | / | >240 | Same as<br>K221269 |
| Busulfan 6mg/ml (6,000 ppm) | >240 | / | >240 | Same as<br>K221269 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 12.9 | 21.4 | 11.1 | Similar |
| Chloroquine 50mg/ml (50,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same |
| | | | | |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same as<br>K221269 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same as<br>K221269 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | / | >240 | Same as<br>K221269 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | / | >240 | Same as<br>K221269 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Irinotecan, 20mg/ml (20,000ppm) | >240 | >240 | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Melphalan, 5mg/ml (5,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 | Same |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Retrovir, 10mg/ml (10,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Rituximab, 10mg/ml (10,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Thio Tepa, 10mg/ml (10,000ppm) | 35.6 | 67.2 | 21.6 | Similar |
| Topotecan, 1mg/ml (1,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Trisenox, 1mg/ml (1,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | / | >240 | Same as<br>K221269 |
| Vincristine Sulfate (Oncovin), 1mg/ml<br>(1,000ppm) | >240 | >240 | >240 | Same |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 | >240 | / | Same as<br>K200581 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | Same |

{9}------------------------------------------------

No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China

## 510K Summary K231643

{10}------------------------------------------------

No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China

## 510K Summary K231643

* Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling.

#### 7. Summary of Non-Clinical Performance Data

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:

| Methodology | Test Performed | Acceptance Criteria | Results |
|----------------------------------------|-----------------------------------|------------------------------------------------------------------------------------------|------------------------------------------|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 220mm for sizes XS and S, 230mm for size M-XXL | Pass |
| ASTM D6319- 19 | Physical Dimensions Palm Width | XS: 70±10mm<br>S: 80±10mm<br>M: 95±10mm<br>L:110±10mm<br>XL: 120±10mm<br>XXL: 130±10mm | Pass |
| ASTM D6319- 19 | Physical Dimensions Thickness | Finger: 0.05mm (min)<br>Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19<br>ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 Mpa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19<br>ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19<br>ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer the above table in Section 5 | Pass |
| ISO 10993-10 &23:2021 | Irritation and Skin Sensitization | Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
| ISO 11737-1:2018 | Open box bioburden study | There is no increase in bioburden levels | Pass |

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ●

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ●

- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ●
- ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05 (Reapproved 2019), Assessment of Resistance of Medical Gloves to Permeation by

{11}------------------------------------------------

No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China

## 510K Summary K231643

Chemotherapy Drugs.

- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Sensitization. ●
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Irritation. ●
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity .
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ●
- . ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products.

#### 8. Clinical Performance Data

N/A

#### 9. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.