Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K223713 · Better Care Plastic Technology Co., Ltd. · LZA · Aug 7, 2023 · General Hospital

Device Facts

• Record ID: K223713
• Device Name: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
• Applicant: Better Care Plastic Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 7, 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.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination glove; worn by healthcare examiners to prevent cross-contamination. Provides barrier protection against patient fluids and specific chemotherapy agents/Fentanyl Citrate. Used in clinical settings. Performance verified via ASTM standards for physical dimensions, tensile strength, and chemical permeation resistance. Output is a physical barrier; healthcare providers use the glove to maintain sterile/clean fields during patient examinations or drug handling. Benefits include reduced risk of exposure to hazardous chemotherapy agents and infectious materials.

Clinical Evidence

No clinical data provided. Bench testing only, including physical properties (ASTM D6319-19), water leak (ASTM D5151-19), powder residue (ASTM D6124-06), and chemotherapy drug permeation (ASTM D6978-05). Biocompatibility testing performed per ISO 10993-5, 10, and 11.

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, non-sterile. Dimensions: Length min 230mm, thickness min 0.05mm. Standards: ASTM D6319-19, ASTM D6978-05(2019), ASTM D412-16, ASTM D5151-19, ASTM D6124-06. Biocompatibility: ISO 10993-5, 10, 11. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs and 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

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

Reference Devices

• Halyard Sterling Nitrile Powder-Free Exam Gloves, Halyard Sterling SG Nitrile Sensi-Guard Powder-Free Exam Gloves (K191230)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 7, 2023

Better Care Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710

Re: K223713

Trade/Device Name: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: July 6, 2023 Received: July 6, 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.

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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 -S

Bifeng Qian, 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223713

Device Name

Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|-----------------------------------------------|-----------------------------------------------|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| Cetuximab (2 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Cytarabine (Cytosine) (100 mg/ml) | >240 |
| Cytovene (10 mg/ml) | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | >240 |
| Daunorubicin HCL (5 mg/ml) | >240 |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 |
| Eribulin Mesylate (0.5 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| 5-Fluorouracil (50 mg/ml) | >240 |
| Fulvestrant (50 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCL (20 mg/ml) | >240 |
| Mechlorethamine HCL (1 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin-C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Pemetrexed (25 mg/ml) | >240 |

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| Pertuzumab (30 mg/ml) | >240 |
|----------------------------------------------------------------------------|-----------------------------------------------|
| Raltitrexed monohydrate (0.5 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Temsirolimus (25 mg/ml) | >240 |
| Thiotepa (10 mg/ml) | 44.4 |
| Topotecan HCL (1 mg/ml) | >240 |
| Trastuzumab (21 mg/ml) | >240 |
| Trisenox (1 mg/ml) | >240 |
| Vinblastine (1 mg/ml) | >240 |
| Vincrinstine Sulfate (1 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Zoledronic Acid (0.8 mg/ml) | >240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time (Minutes) |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | >240 |

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

Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes

Warning: Do not use with Carmustine and Thio Tepa.

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

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|

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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

# 510(K) SUMMARY

The assigned 510(K) numbers: K223713 Date Prepared: August 2, 2023

#### 1. Owner's Identification:

Mrs. Zhu Chunyan Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China Tel:[phone] Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel:[phone] Email: [e-mail] or kathyliu(@hongrayusa.com

### 2. Name of the Device:

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

### 3. Predicate Device Information:

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

Reference device:

O & M Halyard, Inc.

Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves (K191230)

This reference device is being used to support inclusion of additional chemotherapy drugs that were not tested in the predicate.

### 4. Device Description:

Powder Free Nitrile Examination Glove (Grev) Tested for Use with Chemotherapy Drugs and Fentany) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, 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.

### 5. Indications for 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.

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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

The following chemicals have been tested with these gloves: Table 1

| Chemotherapy Drug<br>and Concentration | Minimum Breakthrough Detection<br>Time<br>(Minutes) |
|-----------------------------------------------|-----------------------------------------------------|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| Cetuximab (2 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Cytarabine (Cytosine) (100 mg/ml) | >240 |
| Cytovene (10 mg/ml) | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | >240 |
| Daunorubicin HCL (5 mg/ml) | >240 |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 |
| Eribulin Mesylate (0.5 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| 5-Fluorouracil (50 mg/ml) | >240 |
| Fulvestrant (50 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCL (20 mg/ml) | >240 |
| Mechlorethamine HCL (1 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin-C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Pemetrexed (25 mg/ml) | >240 |
| Pertuzumab (30 mg/ml) | >240 |
| Raltitrexed monohydrate (0.5 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Temsirolimus (25 mg/ml) | >240 |
| Thiotepa (10 mg/ml) | 44.4 |
| Topotecan HCL (1 mg/ml) | >240 |
| Trastuzumab (21 mg/ml) | >240 |
| Trisenox (1 mg/ml) | >240 |
| Vinblastine (1 mg/ml) | >240 |
| Vincrinstine Sulfate (1 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Zoledronic Acid (0.8 mg/ml) | >240 |

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

Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time<br>(Minutes) |
|----------------------------------------------------------------------------|--------------------------------------------------|
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | >240 |

*Please note that the following drugs have extremely low permeation times: Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes

# Warning: Do not use with Carmustine and Thio Tepa.

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

The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs & Fentanyl Citrate of the proposed and predicate devices. General Comparison Table:

| | Subject Device<br>K223713 | Predicate Device<br>K221269 | Reference Device<br>K191230 | Comparison |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Trade Name | Powder Free Nitrile<br>Examination Glove (Grey)<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate | Powder Free Nitrile<br>Examination Glove (Blue)<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate | Halyard Sterling* Nitrile<br>Powder-Free Exam<br>Gloves, Halyard Sterling<br>SG* Nitrile Sensi-Guard<br>Powder-Free Exam<br>Gloves | Similar |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC,QDO | LZC | Different * |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Indications for Use | The device is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with chemotherapy drugs<br>and Fentanyl listed on the<br>label. | The device is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with chemotherapy drugs<br>and Fentanyl listed on the<br>label. | 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<br>listed on the label. | Same as<br>K221269* |
| Material | Nitrile | Nitrile | Nitrile | Same |
| Powder or Powder<br>Free | Powder Free | Powder Free | Powder Free | Same |
| Color | Grey | Blue | Grey | Different<br>from<br>K221269**<br>Same as<br>K191230 |
| Single use | Single use | Single use | Single use | Same |
| Dermal Irritation<br>ISO 10993-10 | Based on the criteria, the test<br>article extracts were<br>considered negligible<br>irritants. | Under the conditions of the<br>study, not an irritant | Based on the criteria and<br>conditions of the study,<br>the test article was<br>considered nonirritating | Same |
| Dermal Sensitization<br>ISO 10993-10 | Based on the criteria<br>and conditions of the<br>study, the test article is<br>classified as a non-sensitizer | Under the conditions of the<br>study, not a sensitizer | Based on the criteria and<br>conditions of the study,<br>the test article showed<br>no evidence of causing<br>delayed dermal contact<br>sensitization | Same |
| Cytotoxicity Test<br>ISO 10993-5 | / | Under the conditions of this<br>study, the test article extract<br>showed potential toxicity to<br>L929 cells.<br>Cytotoxicity<br>concern<br>was<br>addressed by acute systematic<br>toxicity testing. | / | Different<br>from<br>K221269<br>Same as<br>K191230 |
| Acute Systemic<br>Toxicity<br>ISO 10993-11 | Based on the criteria, the test<br>article meets the requirements | Under the conditions of this<br>study, there was no evidence<br>of systemic toxicity. | No mortality of evidence<br>of systemic toxicity<br>from the extracts | Same |
| Chemotherapy Drugs<br>and Fentanyl Citrate<br>Claim | See below comparison table | See below comparison table | See below comparison<br>table | / |
| Technological<br>Characteristics | Subject Device<br>K223713 | Predicate Device<br>K221269 | Reference Device<br>K191230 | Comparison |
| Physical Dimension | | | | |
| Length | Minimum 230mm | Minimum 230mm | Minimum 230mm | 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 |
| 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 |
| 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 |

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

Better Care Plastic Technology Co., Ltd
Fuqian Xi Road, West district of Shenze, Industrial Base,

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

Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

* 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 reguirements but does not raise questions of safety and effectiveness.

** The finished subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not raise questions of safety and effectiveness.

Technological Characteristic Comparison Table:

Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:

| Tested Chemotherapy Drug and | Minimum Breakthrough Detection Time (Minutes) | | | Comparison |
|-------------------------------------------------------------------------------|-----------------------------------------------|------------------|------------------|------------|
| Concentration | Subject Device | Reference Device | Predicate Device | With |
| | K223713 | K191230 | K221269 | K191230 |
| Arsenic Trioxide (1 mg/ml) | >240 | >240 | / | Same |
| Azacitidine (25 mg/ml) | >240 | >240 | / | Same |
| Bendamustine HCL (5 mg/ml) | >240 | >240 | / | Same |
| | | | | |
| Bleomycin sulfate (15 mg/ml) | >240 | >240 | >240 | Same |
| Bortezomib (1 mg/ml) | >240 | >240 | / | Same |
| Busulfan (6 mg/ml) | >240 | >240 | >240 | Same |
| Carboplatin (10 mg/ml) | >240 | >240 | >240 | Same |
| Carfilzomib (2 mg/ml) | >240 | >240 | / | Same |
| Carmustine (3.3 mg/ml) | 13.9 | 14.8 | 11.1 | Similar |
| Cetuximab (2 mg/ml) | >240 | >240 | / | Same |
| Cisplatin (1 mg/ml) | >240 | >240 | >240 | Same |
| Cyclophosphamide (20 mg/ml) | >240 | >240 | >240 | Same |
| Cytarabine (Cytosine) (100 mg/ml) | >240 | >240 | >240 | Same |
| Cytovene (10 mg/ml) | >240 | >240 | / | Same |
| Dacarbazine (DTIC) (10 mg/ml) | >240 | >240 | >240 | Same |
| Daunorubicin HCL (5 mg/ml) | >240 | >240 | >240 | Same |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 | >240 | / | Same |
| Docetaxel (10 mg/ml) | >240 | >240 | >240 | Same |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 | >240 | >240 | Same |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 | >240 | >240 | Same |
| Eribulin Mesylate (0.5 mg/ml) | >240 | >240 | / | Same |
| Etoposide (Toposar) (20 mg/ml) | >240 | >240 | >240 | Same |
| Fludarabine (25 mg/ml) | >240 | >240 | >240 | Same |
| 5-Fluorouracil (50 mg/ml) | >240 | >240 | >240 | Same |
| Fulvestrant (50 mg/ml) | >240 | >240 | / | Same |
| Gemcitabine (38 mg/ml) | >240 | >240 | >240 | Same |
| Idarubicin (1.0 mg/ml) | >240 | >240 | >240 | Same |
| Ifosfamide (50 mg/ml) | >240 | >240 | >240 | Same |
| Irinotecan HCL (20 mg/ml) | >240 | >240 | >240 | Same |
| Mechlorethamine HCL (1 mg/ml) | >240 | >240 | >240 | Same |
| Melphalan (5 mg/ml) | >240 | >240 | >240 | Same |
| Methotrexate (25 mg/ml) | >240 | >240 | >240 | Same |
| Mitomycin-C (0.5 mg/ml) | >240 | >240 | >240 | Same |
| Mitoxantrone (2 mg/ml) | >240 | >240 | >240 | Same |
| Oxaliplatin (2 mg/ml) | >240 | >240 | >240 | Same |
| Paclitaxel (6 mg/ml) | >240 | >240 | >240 | Same |
| Paraplatin (10 mg/ml) | >240 | >240 | >240 | Same |
| Pemetrexed (25 mg/ml) | >240 | >240 | / | Same |
| Pertuzumab (30 mg/ml) | >240 | >240 | / | Same |
| Raltitrexed monohydrate (0.5 mg/ml) | >240 | >240 | / | Same |
| Retrovir (10 mg/ml) | >240 | >240 | >240 | Same |
| Rituximab (10 mg/ml) | >240 | >240 | >240 | Same |
| Temsirolimus (25 mg/ml) | >240 | >240 | / | Same |
| Thiotepa (10 mg/ml) | 44.4 | 23.9 | 21.6 | Similar |
| Topotecan HCL (1 mg/ml) | >240 | >240 | >240 | Same |
| Trastuzumab (21 mg/ml) | >240 | >240 | / | Same |
| Trisenox (1 mg/ml) | >240 | >240 | >240 | Same |
| Vinblastine (1 mg/ml) | >240 | >240 | / | Same |
| Vincrinstine Sulfate (1 mg/ml) | >240 | >240 | >240 | Same |
| Vinorelbine (10 mg/ml) | >240 | >240 | / | Same |
| Zoledronic Acid (0.8 mg/ml) | >240 | >240 | / | Same |
| Tested Fentanyl Citrate and Concentration | | | | |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 | / | >240 | Different* |
| Simulated Gastric Acid Fluid/Fentanyl Citrate<br>Injection Mix 50/50 Solution | >240 | / | / | Different* |

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Fuqian Xi Road, West district of Shenze, Industrial Base,

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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

* Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this different does not raise questions of safety and effectiveness.

#### 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 size XS<br>and S, 230mm for size M, L, XL | Pass |
| ASTM D6319- 19 | Physical Dimensions Palm<br>Width | XS: 70±10mm<br>S: 80±10mm<br>M: 95±10mm<br>L:110±10mm<br>XL: 120±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)<br>and Elongation (Before Aging<br>500% and after aging 400%) Min | Pass |
| ASTM D6319- 19<br>ASTM D5151-19 | Water leak test | G-I, 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<br>Drugs | Refer the above table 1 | Pass |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin<br>irritation | Is non-sensitization<br>and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potential<br>toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity<br>study | Subject showed no adverse<br>biological reaction | no evidence of acute<br>systemic toxicity. |

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. ●

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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

- 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 Reissuance of Medical Gloves to Permeation by . Chemotherapy Drugs.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin ● Sensitization.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity ●
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- 8. Summary of Clinical Testing: Not provided for the subject device.

#### 9. Conclusion:

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