Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs

K233598 · Anhui Intco Medical Products Co., Ltd. · LZA · Jan 26, 2024 · General Hospital

Device Facts

• Record ID: K233598
• Device Name: Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
• Applicant: Anhui Intco Medical Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs 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. These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination glove; worn by healthcare examiners to prevent cross-contamination. Device provides a physical barrier; tested for permeation resistance against various chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Output is the physical barrier itself; used in clinical settings. Healthcare providers use the glove during patient examinations or drug handling to protect against exposure to hazardous substances. Benefits include reduced risk of contamination and chemical exposure, provided the specific drug permeation times are respected.

Clinical Evidence

No clinical data provided. Bench testing only, including physical dimensions, physical properties (tensile strength/elongation), water leak testing (ASTM D5151-19), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-10, 10993-23, 10993-11).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, non-sterile, powder-free. Sizes: XS, S, M, L, XL, XXL. Standards: ASTM D6319-19 (dimensions/physical properties), ASTM D6978-05 (chemotherapy permeation), ASTM D5151-19 (holes), ASTM D6124-06 (powder residue), ASTM D412-16 (tension). Biocompatibility: ISO 10993-10, 10993-23, 10993-11.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs and Fentanyl Citrate; contraindicated for use with Carmustine and Thiotepa.

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

• Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223713)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

January 26, 2024

Anhui Intco Medical Products Co., Ltd. Max Li Quality Specialist No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park Suixi County Huaibei City, Anhui 235000 China

Re: K233598

Trade/Device Name: Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs 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: November 9, 2023 Received: November 9, 2023

Dear Max Li:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Qian, M.D., Ph.D. Assistant Director

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

DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

#### 510(k) Number (if known) K233598

#### Device Name

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs

#### Indications for Use (Describe)

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs 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.

These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Test Chemotherapy drug & Concentration | Minimum Breakthrough Detection Times (Minutes) |
|----------------------------------------|------------------------------------------------|
| Bendamustine HCI; 5 mg/ml | >240 |
| Bleomycin sulfate; 15 mg/ml | >240 |
| Busulfan; 6 mg/ml | >240 |
| Carboplatin; 10 mg/ml | >240 |
| Carfilzomib; 2 mg/ml | >240 |
| Carmustine; 3.3 mg/ml | 1.7 |
| Cetuximab; 2 mg/ml | >240 |
| Cisplatin; 1 mg/ml | >240 |
| Cladribine; 1 mg/ml | >240 |
| Cyclophosphamide; 20 mg/ml | >240 |
| Cytarabine (Cytosine); 100 mg/ml | >240 |
| Cytovene (Ganciclovir); 10 mg/ml | >240 |
| Dacarbazine; 10 mg/ml | >240 |
| Daunorubicin HCL; 5 mg/ml | >240 |
| Decitabine; 5 mg/ml | >240 |
| Docetaxel; 20 mg/ml | >240 |
| Doxorubicin HCL; 2 mg/ml | >240 |
| Epirubicin HCL; 2 mg/ml | >240 |
| Etoposide; 20 mg/ml | >240 |
| Fludarabine Phosphate; 25 mg/ml | >240 |
| Fluorouracil; 50 mg/ml | >240 |
| Fulvestrant; 50 mg/ml | >240 |
| Gemcitabine HCI; 38 mg/ml | >240 |
| Idarubicin HCI; 1 mg/ml | >240 |
| Ifosfamide; 50 mg/ml | >240 |
| Irinotecan HCI; 20 mg/ml | >240 |
| Mechlorethamine HCL; 1 mg/ml | >240 |
| Melphalan HCI; 5 mg/ml | >240 |
| Methotrexate; 25 mg/ml | >240 |
| Mitomycin C; 0.5 mg/ml | >240 |
| Mitoxantrone HCI; 2 mg/ml | >240 |
| Oxaliplatin; 5 mg/ml | >240 |
| Paclitaxel; 6 mg/ml | >240 |

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

| Pemetrexed ; 25 mg/ml | >240 |
|---------------------------------|------|
| Rituximab ; 10 mg/ml | >240 |
| ThioTepa ; 10 mg/ml | 0 |
| Topotecan HCL ; 1 mg/ml | >240 |
| Trisonex ; 1 mg/ml | >240 |
| Velcade (Bortezomib) ; 1 mg/ml | >240 |
| Vidaza (Azacytidine) ; 25 mg/ml | >240 |
| Vincrinstine Sulfate ; 1 mg/ml | >240 |
| Vinorelbine Tartrate, 10 mg/ml | >240 |
| Zoledronic Acid ; 0.8 mg/ml | >240 |

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.7 minutes and Thiotepa:0 minute

Warning: Do not use with Carmustine and Thiotepa

| Fentanyl Citrate & Other Drugs | Minimum Breakthrough Detection Times |
|-------------------------------------------------|--------------------------------------|
| Fentanyl Citrate Injection(100 mcg/2ml) | >240 |
| Chloroquine ; 50mg/ml | >240 |
| Cyclosporin A; 100mg/ml | >240 |
| Retrovir ; 10 mg/ml | >240 |
| Type of Use (Select one or both, as applicable) | |

Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui Province, China

K233598

# 510(K)SUMMARY

## (As required by 21 CFR 807.92) K233598

Date Prepared: Jan. 25. 2024

## 1. Owner's Identification:

Applicant Name: ANHUI INTCO MEDICAL PRODUCTS CO., LTD.

Location: No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui Province ,China

Contact Person: Max Li Tel: [phone]

## 2. Name of the Device:

Trade / Product Name: Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs

Common Name: Exam Gloves Classification Name: Non-Powdered Patient Examination Glove Specialty Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I

## 3. Predicate Device Information:

Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentany) Citrate (K223713) Product code LZA, LZC, QDO, OPJ.

## 4. Device Description:

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large, Extra Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

## 5. Indications for Use:

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No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui Province, China

#### K233598

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs 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.

These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drugs | Minimum Breakthrough Detection Time<br>(minutes) |
|--------------------------------------|--------------------------------------------------|
| Bendamustine HCl; 5 mg/ml | >240 min. |
| Bleomycin sulfate; 15 mg/ml | >240 min. |
| Busulfan; 6 mg/ml | >240 min. |
| Carboplatin; 10 mg/ml | >240 min. |
| Carfilzomib; 2 mg/ml | >240 min. |
| Carmustine; 3.3 mg/ml | 1.7 |
| Cetuximab; 2 mg/ml | >240 min. |
| Cisplatin; 1 mg/ml | >240 min. |
| Cladribine; 1 mg/ml | >240 min. |
| Cyclophosphamide; 20 mg/ml | >240 min. |
| Cytarabine (Cytosine); 100 mg/ml | >240 min. |
| Cytovene (Ganciclovir); 10 mg/ml | >240 min. |
| Dacarbazine; 10 mg/ml | >240 min. |
| Daunorubicin HCL; 5 mg/ml | >240 min. |
| Decitabine; 5 mg/ml | >240 min. |
| Docetaxel; 20 mg/ml | >240 min. |
| Doxorubicin HCl; 2 mg/ml | >240 min. |
| Epirubicin HCl; 2 mg/ml | >240 min. |
| Etoposide; 20 mg/ml | >240 min. |
| Fludarabine Phosphate; 25 mg/ml | >240 min. |
| Fluorouracil; 50 mg/ml | >240 min. |
| Fulvestrant; 50 mg/ml | >240 min. |
| Gemcitabine HCl; 38 mg/ml | >240 min. |
| Idarubicin HCl; 1 mg/ml | >240 min. |
| Ifosfamide; 50 mg/ml | >240 min. |
| Irinotecan HCl; 20 mg/ml | >240 min. |
| Mechlorethamine HCL; 1 mg/ml | >240 min. |
| Melphalan HCl; 5 mg/ml | >240 min. |
| Methotrexate; 25 mg/ml | >240 min. |
| Mitomycin C; 0.5 mg/ml | >240 min. |
| Mitoxantrone HCl; 2 mg/ml | >240 min. |
| Oxaliplatin;5 mg/ml | >240 min. |
| Paclitaxel; 6 mg/ml | >240 min. |
| Pemetrexed; 25 mg/ml | >240 min. |
| Rituximab; 10 mg/ml | >240 min. |
| Thio Tepa; 10 mg/ml | 0 |
| Topotecan HCl; 1 mg/ml | >240 min. |
| Trisenox (Arsenic Trioxide); 1 mg/ml | >240 min. |
| Velcade (Bortezomib); 1 mg/ml | >240 min. |
| Vidaza (Azacytidine); 25mg/ml | >240 min. |
| Vincristine Sulfate; 1 mg/ml | >240 min. |
| Vinorelbine Tartrate; 10 mg/ml | >240 min. |
| Zoledronic Acid; 0.8 mg/ml | >240 min. |

Table 1

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No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui Province, China

K233598

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

Carmustine: 1.7 minutes, Thio Tepa: 0 minutes

Warning: Do not use with Carmustine and Thio Tepa.

| Fentanyl Citrate & Other Drugs | Minimum Breakthrough Detection Time<br>(minutes) |
|-----------------------------------------|--------------------------------------------------|
| Fentanyl Citrate Injection(100 mcg/2ml) | >240 min. |
| Chloroquine; 50mg/ml | >240 min. |
| Cyclosporin A; 100mg/ml | >240 min. |
| Retrovir; 10 mg/ml | >240 min. |

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

The following tables are summaries of the technological characteristics, biocompatibility and

performance testing of the proposed and predicate devices. General Comparison Table:

| Device | Proposed Device | Predicate Device | Comparison |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510K # | K233598 | K223713 | - |
| Product Name | Powder Free Nitrile Examination<br>Glove 2.8 Blue Color, Non-Sterile,<br>and Tested for Use with<br>Chemotherapy Drugs, Fentanyl<br>Citrate, and Select Other Drugs | Powder Free Nitrile Examination<br>Glove (Grey) Tested for Use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate | - |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for<br>use | Powder Free Nitrile Examination<br>Glove 2.8 Blue Color, Non-Sterile,<br>and Tested for Use with<br>Chemotherapy Drugs, Fentanyl<br>Citrate, and Select Other Drugs is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand or finger to prevent<br>contamination between patient and<br>examiner.<br>These gloves were tested for use<br>with Chemotherapy Drugs,<br>Fentanyl Citrate, and Select Other<br>Drugs as per ASTM D6978-05<br>(Reapproved 2019) Standard<br>Practice for Assessment of | The glove is a disposable device<br>intended for medical purposes that is<br>worn on the examiner's hand to<br>prevent contamination between<br>patient and examiner. Gloves have<br>been tested for use with chemotherapy<br>drugs and Fentanyl Citrate. | Same |

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

No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui Province, China

K233598

| | Medical Gloves to Permeation by<br>Chemotherapy Drugs. | | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------|-----------|
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Grey | Different |
| Size | XS, S, M, L, XL, XXL | XS, S, M, L, XL | Different |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single use | Single use | Same |
| Chemotherapy<br>Drugs,<br>Fentanyl<br>Citrate, and<br>Select Other<br>Drugs Claim | See below comparison table | See below comparison table | Similar |

Analysis: The proposed device has size XS, S, M, L, XL, XXL and Blue color, while the predicate device has size XS, S, M, L, XL and Grey color. But safety and performance testing has been done to the proposed device and the results showed that the device meets the requirements of standard ASTM D6319-19. Therefore, this difference does not raise any new safety or performance questions.

Technological Characteristic and Biocompatibility Comparison Table:

| Item | Standard | Proposed device | Predicate device K223713 | Result |
|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimension | ASTM D6319-19 | Minimum 220mm for size<br>XS and S,<br>230mm for size M, L, XL<br>Width(mm):<br>XS: 70±10<br>S: 80±10<br>M: 95±10<br>L: 110±10<br>XL: 120±10<br>XXL: 130±10<br>Thickness(mm):<br>Palm: Minimum 0.05<br>Finger: Minimum 0.05 | Length: Min 230mm<br>Width(mm):<br>XS: 70±10<br>S: 80±10<br>M: 95±10<br>L: 110±10<br>XL: 120±10<br>XXL: /<br>Thickness:(mm)<br>Palm: Minimum 0.05<br>Finger: Minimum 0.05 | Similar |
| Physical properties<br>Before aging<br>Tensile strength<br>Ultimate elongation<br>After aging<br>Tensile strength<br>Ultimate elongation | ASTM D6319-19<br>ASTM D412-16 | 14MPa, min<br>500%, min<br>14MPa, min<br>400%, min | 14MPa, min<br>500%, min<br>14MPa, min<br>400%, min | Same |

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

No. 6, Haitang South Road, Suixi Wedical Products Co.,Ltd.
No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui
Province, Province,

vince, China

| Freedom from holes | ASTM D6319-19<br>ASTM D5151-19 | G-I, AQL2.5 | G-I, AQL2.5 | Same |
|--------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------|
| Residual Powder | ASTM D6319-19<br>ASTM D6124-06 | ≤2 mg per glove | ≤2 mg per glove | Same |
| Biocompatibility | Irritation<br>ISO 10993-23 | Under the conditions of this<br>study, the irritation response<br>category of the test article is<br>classified as Negligible for<br>polar extract and Negligible<br>for non-polar extract. | Based on the criteria, the test<br>article extracts were<br>considered negligible irritants. | Similar(1) |
| | Sensitization ISO<br>10993-10 | The sample extract elicits no<br>sensitization reactions under<br>the test conditions | Based on the criteria and<br>conditions of the study, the<br>test article is classified as a<br>non-sensitizer | Similar |
| | Acute Systemic<br>Toxicity Test ISO<br>10993 -11 | No death or systemic toxicity<br>was observed in the mice<br>which received injection of<br>the extract | Based on the criteria, the test<br>article meets the<br>requirements | Similar |

1) The new version of standard for Skin Irritation we refer is ISO 10993-23:2021, the test method and process is the old version ISO 10993-10

Chemotherapy Permeation, Fentanyl Citrate, and Select Other Drugs Comparison Claim:

| Chemotherapy Drugs, Fentanyl Citrate,<br>and Select Other Drugs | Minimum BDT (Minutes) | | |
|-----------------------------------------------------------------|-----------------------|-----------------------------|------------|
| | Proposed device | Predicate device<br>K223713 | Remark |
| Bendamustine HCI ; 5 mg/ml | >240 min. | >240 min. | Same |
| Bleomycin sulfate ; 15 mg/ml | >240 min. | >240 min. | Same |
| Busulfan ; 6 mg/ml | >240 min. | >240 min. | Same |
| Carboplatin; 10 mg/ml | >240 min. | >240 min. | Same |
| Carfilzomib ; 2 mg/ml | >240 min. | >240 min. | Same |
| Carmustine ; 3.3 mg/ml | 1.7 | 13.9 | Different* |
| Cetuximab ; 2 mg/ml | >240 min. | >240 min. | Same |
| Chloroquine ; 50mg/ml | >240 min. | -- | Different* |
| Cisplatin ; 1 mg/ml | >240 min. | >240 min. | Same |
| Cladribine ; 1 mg/ml | >240 min. | -- | Different* |
| Cyclophosphamide; 20 mg/ml | >240 min. | >240 min. | Same |
| Cyclosporin A; 100mg/ml | >240 min. | -- | Different* |
| Cytarabine (Cytosine) ; 100 mg/ml | >240 min. | >240 min. | Same |
| Cytovene (Ganciclovir); 10 mg/ml | >240 min. | >240 min. | Same |
| Dacarbazine ; 10 mg/ml | >240 min. | >240 min. | Same |
| Daunorubicin HCL; 5 mg/ml | >240 min. | >240 min. | Same |
| Decitabine ; 5 mg/ml | >240 min. | >240 min. | Same |
| Docetaxel ; 20 mg/ml | >240 min. | >240 min. | Same |
| Province, China | | | |
| | | | K233598 |
| Doxorubicin HCL ; 2 mg/ml | >240 min. | >240 min. | Same |
| Epirubicin HCL ; 2 mg/ml | >240 min. | >240 min. | Same |
| Etoposide ; 20 mg/ml | >240 min. | >240 min. | Same |
| Eribulin Mesylate; 0.5 mg/ml | -- | >240 min. | Different* |
| Fludarabine Phosphate; 25 mg/ml | >240 min. | >240 min. | Same |
| Fluorouracil ; 50 mg/ml | >240 min. | >240 min. | Same |
| Fulvestrant ; 50 mg/ml | >240 min. | >240 min. | Same |
| Gemcitabine HCI ; 38 mg/ml | >240 min. | >240 min. | Same |
| Idarubicin HCI ; 1 mg/ml | >240 min. | >240 min. | Same |
| Ifosfamide ; 50 mg/ml | >240 min. | >240 min. | Same |
| Irinotecan HCI ; 20 mg/ml | >240 min. | >240 min. | Same |
| Mechlorethamine HCL; 1 mg/ml | >240 min. | >240 min. | Same |
| Melphalan HCI; 5 mg/ml | >240 min. | >240 min. | Same |
| Methotrexate ; 25 mg/ml | >240 min. | >240 min. | Same |
| Mitomycin C ; 0.5 mg/ml | >240 min. | >240 min. | Same |
| Mitoxantrone HCI ; 2 mg/ml | >240 min. | >240 min. | Same |
| Oxaliplatin ;5 mg/ml | >240 min. | >240 min. | Same |
| Pacilitaxel ; 6 mg/ml | >240 min. | >240 min. | Same |
| Pemetrexed ; 25 mg/ml | >240 min. | >240 min. | Same |
| Pertuzumab; 30 mg/ml | -- | >240 min. | Different* |
| Raltitrexed monohydrate | -- | >240 min. | Different* |
| Retrovir ; 10 mg/ml | >240 min. | >240 min. | Same |
| Rituximab ; 10 mg/ml | >240 min. | >240 min. | Same |
| Temsirolimus ; 25mg/ml | -- | >240 min. | Different* |
| ThioTEPA ; 10 mg/ml | 0 | 44.4 | Different* |
| Topotecan HCL ; 1 mg/ml | >240 min. | >240 min. | Same |
| Trastuzumab ; 21mg/ml | -- | >240 min. | Different* |
| Trisenox (Arsenic Trioxide); 1 mg/ml | >240 min. | >240 min. | Same |
| Velcade (Bortezomib); 1 mg/ml | >240 min. | >240 min. | Same |
| Vidaza (Azacytidine); 25mg/ml | >240 min. | >240 min. | Same |
| Vinblastine ; 1mg/ml | -- | >240 min. | Different* |
| Vincristine Sulfate ; 1 mg/ml | >240 min. | >240 min. | Same |
| Vinorelbine Tartrate; 10 mg/ml | >240 min. | >240 min. | Same |
| Zoledronic Acid ; 0.8 mg/ml | >240 min. | >240 min. | Same |
| Fentanyl; 100mcg/2ml | >240 min. | >240 min. | Same |
| Simulated Gastric Acid | -- | -- | -- |
| Fluid/Fentanyl Citrate Injection Mix<br>50/50 Solution | -- | >240 min. | Different* |

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

No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui
Province, China

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

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

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

No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui
Province, China

K233598

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<br>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<br>XXL: 130±10mm | Pass | |
| ASTM D6319-19 | | Physical Dimensions<br>Thickness | Finger: 0.05mm (min)<br>Palm: 0.05mm (min) | Pass | |
| | | ASTM D6319-19<br>ASTM D412-16 (2021) | Physical Properties | Before aging: 14MPa, min<br>500%, min<br>After aging: 14MPa, min<br>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 |
| ASTM D6978-05 (2019) | | | | Permeation by<br>Chemotherapy Drugs<br>and Fentanyl Citrate | Refer the above table 1 |
| | | ISO 10993-10:2021 | Skin Sensitization | No Skin sensitization | The sample extract<br>elicits no sensitization<br>reactions under the<br>test conditions |
| | | ISO 10993-23:2021 | Irritation | No Skin irritation | Under the conditions<br>of this study, the<br>irritation response<br>category of the test |
| | | | | | |
| | | | article is classified as<br>Negligible for polar<br>extract and Negligible<br>for non-polar extract. | | |
| ISO 10993-11:2017 | Acute systemic toxicity<br>study | Subject showed no adverse<br>biological reaction | No death or acute systemic<br>toxicity was observed<br>in the mice which<br>received injection of<br>the extract | | |

{12}------------------------------------------------

No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Hualbei City, Anhui Province, China

#### K233598

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 Reissuance of Medical Gloves to Permeation by 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 23 : Tests for irritation.
- 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 non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K223713, Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.