Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)

{0}------------------------------------------------ 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 1, 2024 Shandong Xingyu Gloves Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China Re: K233990 Trade/Device Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) 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: March 11, 2024 Received: March 11, 2024 Dear Ivy Wang: 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). Sincerely, # Allan G For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control {2}------------------------------------------------ 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) K233990 Device Name Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) Indications for Use (Describe) The Nitrile Disposable Examination Glove, 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. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The tested chemotherapy 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) 13.2 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) 13.1 Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min The tested non-chemotherapy drugs are: Fentanyl Citrate Injection (100 mcg/2mL) >240 min MESNA (100.0 mg/mL 100,000 ppm) >240 min Trisenox (1.0 mg/ml 1,000 ppm) >240 min Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 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}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(K) Summary # K233990 (As required by 21 CFR 807.92) Date prepared: 2024-04-01 ## A. Applicant: Name: Shandong Xingyu Gloves Co., Ltd. Address: NO. 2158 Yaoqian Road, Economic Development Zone, Gaomi City, Shandong Province, China Contact: Ms. Carrie Lee Title: QA Manager Tel: 0086-536-2580359 Email: carrie@xingyugloves.com Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@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) Model: D5000 Size(s): XS, S, M, L, XL, XXL Regulatory Information Classification Name: Polymer Patient Examination Glove Classification: Class I Product code: LZA (Primary), LZC, OPJ, QDO Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital ## C. Predicate device: 510K Number: K223903 Trade Name: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl Manufacturer: SEMPERIT INVESTMENTS ASIA PTE. LTD. Reference Device {6}------------------------------------------------ #### 510K Number: K212735 Trade Name: Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) Manufacturer: Xingyu Medical Tech Co., Ltd. ### D. Indications for use of the device: The Nitrile Disposable Examination Glove, 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. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The tested chemotherapy 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) | 13.2 | | 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) | 13.1 | | Vincristine Sulfate | (1.0 mg/mL 1,000 ppm | >240 min | | The tested non-chemotherapy drugs are: | | | | Fentanyl Citrate Injection | (100 mcg/2mL) | >240 min | | MESNA | (100.0 mg/mL 100,000 ppm) | >240 min | Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa >240 min (1.0 mg/ml 1,000 ppm) #### E. Device Description: Trisenox The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) 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 six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box. {7}------------------------------------------------ The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard. ### F. Summary of Technological Characteristics Table 1 General Comparison of Proposed and Predicate Devices | Device | Proposed Device | Predicate Device | Result | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510K # | K233990 | K223903 | - | | Product Name | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl | - | | Product Code | LZA (primary), LZC, OPJ, QDO | LZA (primary), LZC, OPJ, QDO | Same | | Classification | Class I | Class I | Same | | Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Indications for use | The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.<br>Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978.<br>The tested chemotherapy drugs are:<br>Chemotherapy drug Concentration<br>Minimum Breakthrough Detection Time<br>Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min<br>Carboplatin (10.0 mg/ml 10,000 ppm) > 240 min<br>Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2<br>Cisplatin (1.0 mg/mL 1,000 ppm) >240 min<br>Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min<br>Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min<br>Dacarbazine (10.0 mg/mL 10,000 ppm) >240 min<br>Doxorubicin HCl (2.0 mg/mL 2,000 | This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner.<br>The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.<br>Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes<br>Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes<br>Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes<br>Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough un | Similar<br>The proposed device and the predicate device have same indications, only minor differences on different drugs and the penetration time of carmustine and thiotepa between the proposed device and the predicate device, which will not raise any new safety or performance | | | | | | | | > 240 min | to 240 minutes | concerns. | | | Etoposide (Toposar) (20.0 mg/mL<br>20,000 ppm) > 240 min | Etoposide (20.0 mg/ml). Permeation<br>time: no breakthrough up to 240<br>minutes | | | | Fluorouracil (5 Flu) (50.0 mg/mL<br>50,000 ppm) >240 min | Fluorouracil (50.0 mg/ml).<br>Permeation time: no breakthrough up<br>to 240 minutes | | | | Idarubicin (1.0 mg/ml 1,000 ppm) ><br>240 min | | | | | Ifosfamide (50.0 mg/mL 50,000 ppm)<br>> 240 min | Ifosfamide (50.0 mg/ml). Permeation<br>time: no breakthrough up to 240<br>minutes | | | | Mechlorethamine HCL (1.0 mg/ml 1,000<br>ppm) > 240 min | Methotrexate (25.0<br>mg/ml). Permeation time: no<br>breakthrough up to 240 minutes | | | | MESNA (100.0 mg/mL 100,000 ppm) ><br>240 min | | | | | Methotrexate (25.0 mg/mL 25,000<br>ppm) >240 min | Mitomycin C (0.5 mg/ml). Permeation<br>time: no breakthrough up to 240<br>minutes | | | | Mitomycin C (0.5 mg/mL 500 ppm) ><br>240 min | | | | | Mitoxantrone HCL (2.0 mg/mL 2,000 ppm<br>> 240 min | Mitoxantrone (2.0 mg/ml).<br>Permeation time: no breakthrough up<br>to 240 minutes | | | | Paclitaxel (6.0 mg/mL 6,000 ppm) ><br>240 min | Paclitaxel (Taxol) (6.0<br>mg/ml). Permeation time: no<br>breakthrough up to 240 minutes | | | | Thiotepa (10.0 mg/mL 10,000 ppm)<br>13.1 | Thiotepa (10.0 mg/ml). Permeation<br>time: Thiotepa has extremely low<br>permeation times of 13.6 minutes | | | | Trisenox (1.0 mg/ml 1,000 ppm) > 240<br>min | Vincristine Sulfate (1.0 mg/ml).<br>Permeation time: no Breakthrough up<br>to 240 minutes. | | | | Vincristine Sulfate (1.0 mg/mL 1,000 ppm<br>>240 min | | | | | Fentanyl Citrate Injection (100 mcg/2mL) ><br>240 min | The tested Opioid is:<br>Fentanyl Citrate Injection<br>(100mcg/2mL). Permeation: no<br>breakthrough up to 240 minutes | | | | Note: Carmustine and Thiotepa have<br>extremely low permeation times of 13.2<br>and 13.1 minutes respectively. | Please note that the following drugs<br>have extremely low permeation times:<br>Carmustine: 14.7 minutes<br>Thiotepa: 13.6 minutes<br>Warning: DO NOT USE WITH<br>CARMUSTINE OR THIOTEPA | | | Powder free | Yes | Yes | Same | | Design<br>feature | Ambidextrous | Ambidextrous | Same | | Material | Nitrile | Nitrile | Same | | Color | Blue | Blue | Same | | OTC use | Yes | Yes | Same | | Sterility | Non-sterile | Non-sterile | Same | | Use | Singe use | Single use | Same | | Labeling claim | Tested for Use with Chemotherapy Drugs<br>and Fentanyl | Tested for Use with Chemotherapy Drugs<br>and Fentanyl | Same | {8}------------------------------------------------ {9}------------------------------------------------ # Table 2 Device dimension comparison | Technological characteristics | Proposed<br>Device<br>(K233990) | Predicate<br>Device<br>(K223903) | Device | Result | |-------------------------------|---------------------------------|----------------------------------|--------|-----------------------…