Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

K240629 · Xingyu Medical Tech Co., Ltd. · LZA · May 28, 2024 · General Hospital

Device Facts

• Record ID: K240629
• Device Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
• Applicant: Xingyu Medical Tech Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: May 28, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, 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.

Device Story

Nitrile disposable examination gloves; non-sterile; ambidextrous; powder-free. Worn by healthcare examiners to prevent cross-contamination. Tested for permeation resistance against various chemotherapy drugs and fentanyl citrate per ASTM D6978-05 (2019). Input: physical barrier protection during clinical examination. Output: barrier protection. Used in clinical settings. Benefits: protects examiner and patient from contamination and exposure to hazardous drugs. Warning: do not use with Carmustine or Thiotepa due to low permeation times.

Clinical Evidence

No clinical data. Bench testing only, including ASTM D6319-19 (physical dimensions, tensile strength, elongation), ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing per ISO 10993-10 and ISO 10993-11 confirmed no sensitization, irritation, or systemic toxicity.

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, blue, powder-free, sizes S-XL. Standards: ASTM D6319-19, ASTM D6978-05, ASTM D5151-19, ASTM D6124-06. Biocompatibility: ISO 10993-10, ISO 10993-11. Non-sterile, single-use.

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 resistance to permeation by 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

• Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232266)

Reference Devices

• Nitrile disposable examination gloves (K212578)

Submission Summary (Full Text)

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May 28, 2024

Xingyu Medical Tech Co., Ltd. % Amanda Sun Technical Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K240629

Trade/Device Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl 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: February 18, 2024 Received: March 6, 2024

Dear Amanda Sun:

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).

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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) K240629

#### Device Name

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Indications for Use (Describe)

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentany], 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. The tested drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Bleomycin sulfate (15.0 mg/ml 15,000 ppm) 240 min

Carboplatin (10.0 mg/ml 10,000 ppm) 240 min

Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 26.7

Cisplatin (1.0 mg/mL 1,000 ppm) 240 min

Cyclophosphamide (20.0 mg/mL 20,000 ppm) 240 min

Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) 240 min

Dacarbazine (10.0 mg/mL 10,000 ppm) 240 min

Doxorubicin HCL (2.0 mg/mL 2,000 ppm) 240 min

Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) 240 min

Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) 240 min

Idarubicin (1.0 mg/ml 1,000 ppm) 240 min

Ifosfamide (50.0 mg/mL 50,000 ppm) 240 min

Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) 240 min

Methotrexate (25.0 mg/mL 25,000 ppm) 240 min

Mitomycin C (0.5 mg/mL 500 ppm) 240 min

Mitoxantrone HCL (2.0 mg/mL 2,000 ppm 240 min

Paclitaxel (6.0 mg/mL 6,000 ppm) 240 min

Thiotepa (10.0 mg/mL 10,000 ppm) 37.6

Vincristine Sulfate (1.0 mg/mL 1,000 ppm 240 min

Non Chemotherapy Drug MESNA (100.0 mg/mL 100,000 ppm) 240 min Trisenox (1.0 mg/ml 1,000 ppm) 240 min Fentanyl Citrate Injection (100 mcg/2mL) 240 min

Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 510(K) Summary

K240629

#### Summary Preparation Date: May 14, 2024

#### A. Applicant:

Name: Xingyu Medical Tech Co., Ltd. Address: No.2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China Contact: Ms. Carrie Lee Title: QA Manager Tel: [phone] Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Amanda Sun Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

#### B. Device:

Trade Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Common Name: Nitrile Patient Examination Gloves (Powder Free) Size(s): S, M, L, XL

#### Regulatory Information

Classification Name: Non-Powdered Patient Examination Glove Classification: Class I Product code: LZA, LZC, OPJ, QDO Requlation Number: 21 CFR 880.6250 Review Panel: General Hospital

#### C. Predicate device:

Primary Predicate Device: K232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Better Care Plastic Technology Co., Ltd.

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Reference Device K212578 Nitrile disposable examination gloves Xingyu Medical Tech Co., Ltd.

#### D. Indications for use of the device:

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl,

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.

The tested drugs are:

| Drugs | Concentration | Minimum Breakthrough<br>Detection Time |
|------------------------------------|---------------------------|----------------------------------------|
| The tested chemotherapy drugs are: | | |
| Bleomycin sulfate | (15.0 mg/ml 15,000 ppm) | >240 min |
| Carboplatin | (10.0 mg/ml 10,000 ppm) | >240 min |
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 26.7 |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | >240 min |
| Cyclophosphamide | (20.0 mg/mL 20,000 ppm) | >240 min |
| Cytarabine (Cytosine) | (100.0 mg/mL 100,000 ppm) | >240 min |
| Dacarbazine | (10.0 mg/mL 10,000 ppm) | >240 min |
| Doxorubicin HCL | (2.0 mg/mL 2,000 ppm) | >240 min |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | >240 min |
| Fluorouracil (5 Flu) | (50.0 mg/mL 50,000 ppm) | >240 min |
| Idarubicin | (1.0 mg/ml 1,000 ppm) | >240 min |
| Ifosfamide | (50.0 mg/mL 50,000 ppm) | >240 min |
| Mechlorethamine HCL | (1.0 mg/ml 1,000 ppm) | >240 min |
| Methotrexate | (25.0 mg/mL 25,000 ppm) | >240 min |
| Mitomycin C | (0.5 mg/mL 500 ppm) | >240 min |
| Mitoxantrone HCL | (2.0 mg/mL 2,000 ppm) | >240 min |
| Paclitaxel | (6.0 mg/mL 6,000 ppm) | >240 min |

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| Thiotepa | (10.0 mg/mL 10,000 ppm) | 37.6 |
|----------------------------------------|---------------------------|----------|
| Vincristine Sulfate | (1.0 mg/mL 1,000 ppm) | >240 min |
| The tested non-chemotherapy drugs are: | | |
| MESNA | (100.0 mg/mL 100,000 ppm) | >240 min |
| Trisenox (Arsenic Trioxide) | (1.0 mg/ml 1,000 ppm) | >240 min |
| Fentanyl Citrate Injection | (100 mcg/2mL) | >240 min |

Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively.

Warning: Do Not Use with Carmustine, Thiotepa

#### E. Device Description:

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in four sizes, small, medium and large, extra-large, packed in a paper box.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05 (Reapproved 2019). The gloves are as same as the Nitrile disposable examination gloves (Model D5000) cleared under K212578 also produced by Xingyu Medical Tech Co., Ltd. The materials and the manufacturing process technology are the same. The proposed device is increased test of Chemotherapy Drug and Fentanyl. Testing has been conducted on the proposed device passed as per ASTM D6978-05 (Reapproved 2019).

#### F. Summary of Technological Characteristics

#### Table 2 Comparison of Proposed, Predicate Devices and Reference Device

| Device | Proposed Device | Predicate Device | Reference Device | Result |
|--------------|--------------------------------|---------------------------------------------|--------------------------------|--------------------------------------------------|
| 510K # | K240629 | K232266 | K212578 | N/A |
| Manufacturer | XINGYU MEDICAL TECH<br>CO.,LTD | Better Care Plastic<br>Technology Co., Ltd. | XINGYU MEDICAL TECH<br>CO.,LTD | Different from<br>Predicate<br>Same as Reference |

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| Product Name | Nitrile Examination Disposable Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Nitrile disposable examination gloves | - |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Product Code | LZA (primary), LZC, OPJ, QDO | LZA (primary), LZC, OPJ, QDO | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for use | The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, 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.<br>The tested chemotherapy drugs are: | The device 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.<br>The following Chemotherapy Drugs have been tested with these gloves: | Nitrile Disposable Examination Gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | ① Similar as K232266 |
| | Drugs<br>The tested chemotherapy drugs are:<br>Bleomycin sulfate (15.0 mg/ml 15,000 ppm)<br>Carboplatin (10.0 mg/ml 10,000 ppm)<br>Carmustine (BCNU) (3.3mg/mL 3,300 ppm)<br>Cisplatin (1.0 mg/ml 1,000 ppm)-<br>Cyclophosphamide (20.0 mg/ml. 20,000 ppm)<br>Cytarabine (Cytosine) (100.0 mg/ml 100,000 ppm)<br>Dacarbazine (10.0 mg/ml 10,000 ppm)<br>Doxorubicin HCL (2.0 mg/mL 2.000 ppm)<br>Etoposide (Toposar) (20.0 mg/ml 20,000 ppm)<br>Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm)<br>Idarubicin (1.0 mg/ml 1,000 ppm)<br>Ifosfamide- (50.0 mg/ml 50,000 ppm)<br>Mechlorethamine HCL (1.0 mg/ml 1,000 ppm)<br>Methotrexate- (25.0 mg/ml, 25,000 ppm)<br>Mitomycin C (0.5 mg/ml 500 ppm)<br>Mitoxantrone HCL (2.0 mg/ml 2,000 ppm<br>Paclitaxel (6.0 mg/mL 6,000 ppm)<br>Thiotepa (10.0 mg/ml, 10,000 ppm)<br>Vincristine Sulfate (1.0 mg/ml 1,000 ppm)<br>The tested non-chemotherapy drugs are:<br>MESNA (100.0 mg/ml 100,000 ppm)<br>Trisenax (Arsenic Trioxide) (1.0 mg/ml 1,000 ppm)<br>Fentanyl Citrate Injection (100 mcg/2mL)<br>Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively.<br>Warning: Do Not Use with Carmustine, Thiotepa. | Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes<br>Bleomycin Sulfate 15mg/ml (15000 ppm) >240<br>Busulfan 6mg/ml (6,000 ppm) >240<br>Carboplatin 10mg/ml (10,000 ppm) >240<br>Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 22.8<br>Chloroquine 50mg/ml (50,000ppm) >240<br>Cisplatin 1mg/ml (1,000 ppm) >240+<br>Cyclophosphamide 20mg/ml (20,000 ppm) >240<br>Cyclosporin 100 mg/ml (100,000 ppm) >240<br>Cytarabine HCL, 100 mg/ml (100,000 ppm) >240<br>Dacarbazine 10 mg/ml (10,000 ppm) >240<br>Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240<br>Docetaxel, 10 mg/ml (10,000 ppm) >240<br>Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240<br>Epirubicin HCL, 2 mg/ml (2,000 ppm) >240<br>Etoposide, 20 mg/ml (20,000 ppm) >240<br>Fludarabine, 25 mg/ml (25,000 ppm) >240<br>Fluorouracil, 50mg/ml (50,000ppm) >240+<br>Gemcitabine, 38mg/ml (38,000ppm) >2400<br>Idarubicin HCL, 1mg/ml (1,000ppm) >2400<br>Ifosfamide, 50mg/ml (50,000ppm) >240<br>Irinotecan, 20mg/ml (20,000ppm) >240<br>Mechlorethamine HCI, 1mg/ml (1,000ppm) >240<br>Melphalan, 5mg/ml (5,000ppm) >240<br>Methotrexate, -25mg/ml (25,000ppm) >240<br>Mitomycin C, 0.5mg/ml (500ppm) >240+<br>Mitoxantrone HCL, 2mg/ml (2,000ppm) >240<br>Oxaliplatin, 5mg/ml (5,000ppm) >240<br>Paclitaxel, 6mg/ml (6,000ppm) >240<br>Paraplatin, 10mg/ml (10,000ppm) >240<br>Retrovir, 10mg/ml (10,000ppm) >2400<br>Rituximab, 10mg/ml (10,000ppm)+ >240<br>Thiotepa, 10mg/ml (10,000ppm) 46.9<br>Topotecan, 1mg/ml(1,000ppm) >240<br>Trisenox, 1mg/ml (1,000ppm) >240<br>Velcade, 1mg/ml (1,000ppm) >240<br>Vincristine Sulfate, 1mg/ml (1,000ppm) >240<br>Fentanyl-Citrate Injection (100-mcg/2ml) >240<br>Please note that the following drugs have extremely low permeation times:<br>Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes, Or<br>*Warning: Do not use with Carmustine and Thiotepa | | |

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| Size | S, M, L, XL | XS, S, M, L, XL, XXL | S, M, L, XL | ② Similar<br>as<br>K232266 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Powder<br>Free | Yes | Yes | Yes | Same |
| Material | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| OTC use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Single<br>Patient Use | Singe use | Singe use | Singe use | Same |
| Labeling<br>claim | Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl | Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl | Not Tested for use with<br>Chemotherapy Drugs and<br>Fentanyl | Same as<br>K232266 |
| Dimensions<br>(Length) | Min 220mm for size S<br>Min 230mm for size M-XL | Min 220mm for size XS, S<br>Min 230mm for size M-XXL | 230 mm min for all size | ② Similar<br>as<br>K232266 |
| Dimensions<br>(width) | S: 80±10<br>M: 95±10<br>L: 110±10<br>XL: 120±10 | XS: 70±10<br>S: 80±10<br>M: 95±10<br>L: 110±10<br>XL: 120±10<br>XXL: 130±10 | S: 83-89 mm<br>M: 88-100mm<br>L: 103-111mm<br>XL: 114-119mm | ② Similar<br>as<br>K232266 |
| Dimensions<br>(thickness) | Minimum Palm ≥0.05 mm<br>Minimum Finger ≥0.05 mm | Minimum Palm ≥0.05 mm<br>Minimum Finger ≥0.05 mm | Minimum ≥ 0.09 (Finger)<br>Minimum ≥0.05 mm(Palm) | Same as<br>K232266 |
| Physical<br>properties | Complies with: ASTM<br>D6319-19<br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Complies with: ASTM<br>D6319-19<br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Complies with: ASTM D6319-19<br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Same |
| Freedom<br>from holes | Meets ASTM D 6319-19<br>Tested in accordance with<br>ASTM D5151-19 with<br>acceptable results | Meets ASTM D 6319-19<br>Tested in accordance with<br>ASTM D5151-19 with<br>acceptable results | Meets ASTM D 6319-19<br>Tested in accordance with<br>ASTM D5151-19 with<br>acceptable results | Same |

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| Residual<br>Powder | Meet the requirements of<br>ASTM D6124 | | Meet the requirements of<br>ASTM D6124 | | Meet the<br>requirements of<br>ASTM D6124 | Same | |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------|---------------------------------------------------|
| Chemotherapy<br>and<br>non-chemo<br>therapy Drugs<br>Tested with<br>Minimum<br>Breakthrough<br>Detection<br>Time as<br>tested per<br>ASTM D6978 | Drugs | Concentration | Minimum Breakthrough<br>Detection Time | Chemotherapy Drug | Minimum Breakthrough<br>Detection Time (BDT)<br>in Minutes | NA | ①<br>Different<br>as<br>K232266 |
| | The tested chemotherapy drugs are: | | | | | | |
| | Bleomycin sulfate | (15.0 mg/ml 15,000 ppm) | >240 min | Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | | |
| | Carboplatin | (10.0 mg/ml 10,000 ppm) | >240 min | Busulfan 6mg/ml (6,000 ppm) | >240 | | |
| | Carmustine (BCNU) | (3.3mg/ml. 3,300 ppm) | 26.7 | Carboplatin 10mg/ml (10,000 ppm) | >240 | | |
| | Cisplatine | (1.0 mg/mL 1,000 ppm) | >240 min | Carmustine (BCNU) 3.3 mg/ml(3,300 ppm) | 22.8 | | |
| | Cyclophosphamide | (20.0mg/mL 20,000 ppm) | >240 min | Chloroquine 50mg/ml (50,000ppm) | >240 | | |
| | Cytarabine (Cytosine) | (100.0 mg/mL 100,000 ppm) | >240 min | Cisplatin 1mg/ml (1,000 ppm) | >240 | | |
| | Dacarbazine | (10.0 mg/mL. 10,000 ppm) | >240 min | Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | | |
| | Doxorubicin HCL | (2.0 mg/mL-2,000 ppm) | >240 min | Cyclosporin 100 mg/ml (100,000 ppm) | >240 | | |
| | Etoposide (Toposar) | (20.0 mg/ml. 20,000 ppm) | >240 min | Cytarabine HCL, 100 mg/ml(100,000 ppm) | >240 | | |
| | Fluorouracil (5-Flu) | (50.0 mg/mL 50,000 ppm) | >240 min | Dacarbazine 10 mg/ml (10,000 ppm) | >240 | | |
| | Idarubicin | (1.0 mg/ml 1,000 ppm) | >240 min | Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | | |
| | Ifosfamide | (50.0 mg/ml 50,000 ppm) | >240 min | Docetaxel, 10 mg/ml (10,000 ppm) | >240 | | |
| | Mechlorethamine HCL | (1.0 mg/ml 1,000 ppm) | >240 min | Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | |
| | Methotrexate | (25.0 mg/mL 25,000 ppm) | >240 min | Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | |
| | | | Etoposide, 20 mg/ml (20,000 ppm) | >240 | | | |
| Mitomycin C+ | (0.5 mg/mL-500 ppm) | >240 min | Fludarabine, 25 mg/ml (25,000 ppm) | >240 | | | |
| Mitoxantrone HCL | (2.0 mg/mL 2,000 ppm | >240 min | Fluorouracil, 50mg/ml (50,000ppm) | >240 | | | |
| Paclitaxel | (6.0 mg/mL 6,000 ppm) | >240 min | Gemcitabine, 38mg/ml (38,000ppm) | >240 | | | |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 37.6 | Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | | | |
| Vincristine Sulfate | (1.0 mg/mL 1,000 ppm | >240 min | Ifosfamide, 50mg/ml (50,000ppm) | >240 | | | |
| The tested non-chemotherapy drugs are: | | | Irinotecan, 20mg/ml(20,000ppm) | >240 | | | |
| MESNA | (100.0 mg/mL 100,000 ppm) | >240 min | Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | | | |
| Trisenox (Arsenic Trioxide) | (1.0 mg/ml 1,000 ppm) | >240 min | Melphalan, 5mg/ml (5,000ppm) | >240 | | | |
| Fentanyl Citrate Injection | (100 mcg/2mL) | >240 min | 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 | | | |
| | | | Thiotepa, 10mg/ml (10,000ppm) | 46.9 | | | |
| | | | Topotecan, 1mg/ml (1,000ppm) | >240 | | | |
| | | | Trisenox, 1mg/ml (1,000ppm) | >240 | | | |
| | | | Velcade, 1mg/ml(1,000ppm) | >240 | | | |
| | | | Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | | | |
| | | | Fentanyl Citrate Injection (100 mcg/2ml) | >240 | | | |
| Note: Carmustine and Thiotepa have<br>extremely low permeation times of<br>26.7 and 37.6 minutes respectively. | | | Please note that the following drugs<br>have extremely low permeation times:<br>Carmustine: 22.8<br>minutes, Thiotepa: 46.9 minutes, Or | | | | |
| Warning: Do Not Use with Carmustine,<br>Thiotepa. | | | *Warning: Do not use with<br>Carmustine and Thiotepa. | | | | |
| Material | Nitrile | | Nitrile | | Nitrile | Same | |
| Biocompatibility<br>Sensitization<br>ISO<br>10993-10 | Under the conditions of the<br>study, not an irritant Under the<br>conditions of the study, not a<br>sensitizer | | Under the conditions of the study,<br>not an irritant<br>Under the conditions of the study,<br>not a sensitizer |…