(83 days)
No
The device is a disposable examination glove and the description focuses on its material properties and testing against chemical permeation, with no mention of AI or ML.
No
The device is a disposable examination glove intended to prevent contamination between the patient and the examiner, not to treat a disease or condition.
No
Explanation: The device is a glove for preventing contamination, not for diagnosing conditions.
No
The device is a physical product (gloves) and the description focuses on material properties, manufacturing standards, and performance testing related to chemical resistance and physical integrity, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a disposable device worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is a barrier device for personal protection and infection control.
- Mechanism of Action: The device works by providing a physical barrier. It does not perform any diagnostic testing on biological samples (in vitro).
- Performance Metrics: The performance metrics listed relate to the physical properties of the glove (tensile strength, freedom from holes), biocompatibility, and resistance to permeation by certain drugs. These are not diagnostic performance metrics like sensitivity, specificity, or AUC.
- Regulatory Standards: The device is tested against standards for examination gloves (ASTM D6319-19) and resistance to chemotherapy drugs and fentanyl (ASTM D6978-05). These are not standards typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / 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. The tested drugs are: Chemotherapy Durg 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Not Specified
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility Testing: Performed according to ISO 10993-1:2018 for Surface Device category, Skin Contact, and duration of contact is A-Limited (≤24h). Tests conducted: ISO 10993-10: Primary Skin Irritation, ISO 10993-10: Dermal Sensitization, ISO 10993-11: Systemic Toxicity. All tests resulted in "Pass".
- Physical Performance Testing: Conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. Tests included:
- Dimensions (Length, Width, Thickness) per ASTM D6319-19: Pass
- Physical properties (Tensile Strength, Elongation Before Aging, After Aging) per ASTM D6319-19: Pass
- Freedom from holes per ASTM D5151-19: Pass
- Residual Powder per ASTM D 6124-06 (2022): Pass
- Permeation Testing: Conducted according to ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times determined for a wide range of chemotherapy drugs and Fentanyl. Results are listed in Table 2, all showing "Pass" generally with breakthrough times >240 min, except for Carmustine (26.7 min) and Thiotepa (37.6 min), which are noted with a warning not to use.
Key results: The product meets specifications for physical properties, dimensions, freedom from holes, residual powder, and resistance to permeation by specified chemotherapy drugs and fentanyl, except for Carmustine and Thiotepa. The biocompatibility tests also passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
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.
4
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5
510(K) Summary
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: +86-0536-2588123 Email: medical@xingyugloves.com
Submission Correspondent: Primary contact: Ms. Amanda Sun Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jingyu.sun@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
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.
6
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
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 | |||
| CO.,LTD | Better Care Plastic | |||
| Technology Co., Ltd. | XINGYU MEDICAL TECH | |||
| CO.,LTD | Different from | |||
| Predicate | ||||
| Same as Reference |
8
| 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. | |||
| 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. | |||
| 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 | ||||
| The tested chemotherapy drugs are: | ||||
| Bleomycin sulfate (15.0 mg/ml 15,000 ppm) | ||||
| Carboplatin (10.0 mg/ml 10,000 ppm) | ||||
| Carmustine (BCNU) (3.3mg/mL 3,300 ppm) | ||||
| Cisplatin (1.0 mg/ml 1,000 ppm)- | ||||
| Cyclophosphamide (20.0 mg/ml. 20,000 ppm) | ||||
| Cytarabine (Cytosine) (100.0 mg/ml 100,000 ppm) | ||||
| Dacarbazine (10.0 mg/ml 10,000 ppm) | ||||
| Doxorubicin HCL (2.0 mg/mL 2.000 ppm) | ||||
| Etoposide (Toposar) (20.0 mg/ml 20,000 ppm) | ||||
| Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) | ||||
| Idarubicin (1.0 mg/ml 1,000 ppm) | ||||
| Ifosfamide- (50.0 mg/ml 50,000 ppm) | ||||
| Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) | ||||
| Methotrexate- (25.0 mg/ml, 25,000 ppm) | ||||
| Mitomycin C (0.5 mg/ml 500 ppm) | ||||
| Mitoxantrone HCL (2.0 mg/ml 2,000 ppm | ||||
| Paclitaxel (6.0 mg/mL 6,000 ppm) | ||||
| Thiotepa (10.0 mg/ml, 10,000 ppm) | ||||
| Vincristine Sulfate (1.0 mg/ml 1,000 ppm) | ||||
| The tested non-chemotherapy drugs are: | ||||
| MESNA (100.0 mg/ml 100,000 ppm) | ||||
| Trisenax (Arsenic Trioxide) (1.0 mg/ml 1,000 ppm) | ||||
| Fentanyl Citrate Injection (100 mcg/2mL) | ||||
| Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively. | ||||
| Warning: Do Not Use with Carmustine, Thiotepa. | Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes | |||
| Bleomycin Sulfate 15mg/ml (15000 ppm) >240 | ||||
| Busulfan 6mg/ml (6,000 ppm) >240 | ||||
| Carboplatin 10mg/ml (10,000 ppm) >240 | ||||
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 22.8 | ||||
| Chloroquine 50mg/ml (50,000ppm) >240 | ||||
| Cisplatin 1mg/ml (1,000 ppm) >240+ | ||||
| Cyclophosphamide 20mg/ml (20,000 ppm) >240 | ||||
| Cyclosporin 100 mg/ml (100,000 ppm) >240 | ||||
| Cytarabine HCL, 100 mg/ml (100,000 ppm) >240 | ||||
| Dacarbazine 10 mg/ml (10,000 ppm) >240 | ||||
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240 | ||||
| Docetaxel, 10 mg/ml (10,000 ppm) >240 | ||||
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 | ||||
| Epirubicin HCL, 2 mg/ml (2,000 ppm) >240 | ||||
| Etoposide, 20 mg/ml (20,000 ppm) >240 | ||||
| Fludarabine, 25 mg/ml (25,000 ppm) >240 | ||||
| Fluorouracil, 50mg/ml (50,000ppm) >240+ | ||||
| Gemcitabine, 38mg/ml (38,000ppm) >2400 | ||||
| Idarubicin HCL, 1mg/ml (1,000ppm) >2400 | ||||
| Ifosfamide, 50mg/ml (50,000ppm) >240 | ||||
| Irinotecan, 20mg/ml (20,000ppm) >240 | ||||
| Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 | ||||
| Melphalan, 5mg/ml (5,000ppm) >240 | ||||
| Methotrexate, -25mg/ml (25,000ppm) >240 | ||||
| Mitomycin C, 0.5mg/ml (500ppm) >240+ | ||||
| Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 | ||||
| Oxaliplatin, 5mg/ml (5,000ppm) >240 | ||||
| Paclitaxel, 6mg/ml (6,000ppm) >240 | ||||
| Paraplatin, 10mg/ml (10,000ppm) >240 | ||||
| Retrovir, 10mg/ml (10,000ppm) >2400 | ||||
| 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 | ||||
| Please note that the following drugs have extremely low permeation times: | ||||
| Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes, Or | ||||
| *Warning: Do not use with Carmustine and Thiotepa |
9
| Size | S, M, L, XL | XS, S, M, L, XL, XXL | S, M, L, XL | ② Similar
as
K232266 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Powder
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
Patient Use | Singe use | Singe use | Singe use | Same |
| Labeling
claim | Tested for Use with
Chemotherapy Drugs and
Fentanyl | Tested for Use with
Chemotherapy Drugs and
Fentanyl | Not Tested for use with
Chemotherapy Drugs and
Fentanyl | Same as
K232266 |
| Dimensions
(Length) | Min 220mm for size S
Min 230mm for size M-XL | Min 220mm for size XS, S
Min 230mm for size M-XXL | 230 mm min for all size | ② Similar
as
K232266 |
| Dimensions
(width) | S: 80±10
M: 95±10
L: 110±10
XL: 120±10 | XS: 70±10
S: 80±10
M: 95±10
L: 110±10
XL: 120±10
XXL: 130±10 | S: 83-89 mm
M: 88-100mm
L: 103-111mm
XL: 114-119mm | ② Similar
as
K232266 |
| Dimensions
(thickness) | Minimum Palm ≥0.05 mm
Minimum Finger ≥0.05 mm | Minimum Palm ≥0.05 mm
Minimum Finger ≥0.05 mm | Minimum ≥ 0.09 (Finger)
Minimum ≥0.05 mm(Palm) | Same as
K232266 |
| Physical
properties | Complies with: ASTM
D6319-19
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Complies with: ASTM
D6319-19
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Complies with: ASTM D6319-19
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Same |
| Freedom
from holes | Meets ASTM D 6319-19
Tested in accordance with
ASTM D5151-19 with
acceptable results | Meets ASTM D 6319-19
Tested in accordance with
ASTM D5151-19 with
acceptable results | Meets ASTM D 6319-19
Tested in accordance with
ASTM D5151-19 with
acceptable results | Same |
10
| Residual
Powder | Meet the requirements of
ASTM D6124 | | Meet the requirements of
ASTM D6124 | | Meet the
requirements of
ASTM D6124 | Same | |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------|---------------------------------------------------|
| Chemotherapy
and
non-chemo
therapy Drugs
Tested with
Minimum
Breakthrough
Detection
Time as
tested per
ASTM D6978 | Drugs | Concentration | Minimum Breakthrough
Detection Time | Chemotherapy Drug | Minimum Breakthrough
Detection Time (BDT)
in Minutes | NA | ①
Different
as
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
extremely low permeation times of
26.7 and 37.6 minutes respectively. | | | Please note that the following drugs
have extremely low permeation times:
Carmustine: 22.8
minutes, Thiotepa: 46.9 minutes, Or | | | | |
| Warning: Do Not Use with Carmustine,
Thiotepa. | | | *Warning: Do not use with
Carmustine and Thiotepa. | | | | |
| Material | Nitrile | | Nitrile | | Nitrile | Same | |
| Biocompatibility
Sensitization
ISO
10993-10 | Under the conditions of the
study, not an irritant Under the
conditions of the study, not a
sensitizer | | Under the conditions of the study,
not an irritant
Under the conditions of the study,
not a sensitizer | | Under the
conditions of the
study, not an irritant
Under the
conditions of the
study, not a
sensitizer | Same | |
| Biocompatibility
Cytotoxicity
ISO
10993-5 | Not Performed | | | Under the conditions of this
study, the test article extract
showed potential toxicity to L929
cells.
Cytotoxicity concern was
addressed by acute
systematic toxicity testing. | | Not Performed | ②Different
as
K232266
Same as
K212578 |
11
| Biocompatibility
Acute
Systemic
Toxicity
ISO
10993-11 | Under the conditions of the
study, the device extract does
not induce acute systemic
toxicity response. | Under the conditions of this
study, there was no evidence of
acute systemic toxicity. | Under the
conditions of this
study, there was
no evidence of
acute systemic
toxicity. | Same |
| ---------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ | ------ |
|---|
12
G. Summary of Non-Clinical Testing
A Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the proposed device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the proposed device were conducted to evaluate the biocompatibility of Nitrile Disposable Examination Gloves as per Guidance for Industry and FDA Staff-Medical Glove Guidance Manual issued on January 22, 2008:
- ISO 10993-10: Primary Skin Irritation
- · ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Systemic Toxicity
> Performance Testing
Physical performance testing of the proposed device were conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 (2022) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
From the test result, we can find the product can meet the requirements as its intended use indicated.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions | |||
| (Length)(width) | |||
| (thickness) | |||
| ASTM D6319-19 | The purpose of the test is to | ||
| Evaluate the physical dimension of | |||
| the glove | Length | ||
| S: $\geq$ 220mm | |||
| M,L,XL: $\geq$ 230mm | |||
| Width | |||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L: 110±10mm | |||
| XL: 120±10mm | Pass | ||
| Pass | |||
| Pass |
13
| Physical properties
ASTM D6319-19 | The purpose of the test is to
evaluate the tensile strength and
ultimate elongation before and
after aging | Tensile Strength:
Before Aging ≥14
MPa, min. After
Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Pass |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Freedom from holes
ASTM D5151-19 | The purpose of the test is to detect
holes in the gloves | No leakage at sampling
level of G-1, AQL 2.5 | Pass |
| Residual Powder
ASTM D 6124-06
(2022) | The purpose of the test is to detect
the powder residue in the glove |