Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. July 20, 2023 Central Medicare Sdn. Bhd. Chua Kah Ying Product Executive PT 2609-2620, Batu 8, Jalan Changkat Jong Teluk Intan, Perak 36000 Malaysia Re: K230875 Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims 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: May 23, 2023 Received: May 25, 2023 Dear Chua Kah Ying: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Allan Guan -S For Bifeng Oian, 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230875 #### Device Name Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Castric Acid and Fentanyl Permeation Resistance Claims #### Indications for Use (Describe) Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05. Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results. Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: | Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes | |----------------------------|---------------|----------------------------------------| | Arsenic Trioxide | 1.0 mg/ml | > 240 minutes | | Azacitidine (Vidaza) | 25.0 mg/ml | > 240 minutes | | Bendamustine HCl | 5.0 mg/ml | > 240 minutes | | Bleomycin Sulfate | 15.0 mg/ml | > 240 minutes | | Busulfan | 6.0 mg/ml | > 240 minutes | | Carboplatin | 10.0 mg/ml | > 240 minutes | | Carmustine (BCNU) | 3.3 mg/ml | 77.6 minutes | | Carfilzomib | 2.0 mg/ml | > 240 minutes | | Cisplatin | 1.0 mg/ml | > 240 minutes | | Cladribine | 1.0 mg/ml | > 240 minutes | | Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 minutes | | Cytarabine | 100.0 mg/ml | > 240 minutes | | Dacarbazine | 10.0 mg/ml | > 240 minutes | | Daunorubicin | 5.0 mg/ml | > 240 minutes | | Decitibine | 5.0 mg/ml | > 240 minutes | | Docetaxel | 10.0 mg/ml | > 240 minutes | | Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 minutes | | Epirubicin (Ellence) | 2.0 mg/ml | > 240 minutes | | Etoposide (Toposar) | 20.0 mg/ml | > 240 minutes | | Fludarabine | 25.0 mg/ml | > 240 minutes | | Fluorouracil | 50.0 mg/ml | > 240 minutes | | Gemcitabine (Gemzar) | 38.0 mg/ml | > 240 minutes | | Idarubicin | 1.0 mg/ml | > 240 minutes | | Ifosfamide | 50.0 mg/ml | > 240 minutes | | Irinotecan | 20.0 mg/ml | > 240 minutes | | Mechlorethamine HCl | 1.0 mg/ml | > 240 minutes | | Melphalan | 5.0 mg/ml | > 240 minutes | | Mesna | 50.0 mg/ml | > 240 minutes | | Methotrexate | 25.0 mg/ml | > 240 minutes | | Mitomycin C | 0.5 mg/ml | > 240 minutes | | Mitoxantrone | 2.0 mg/ml | > 240 minutes | | Oxaliplatin | 2.0 mg/ml | > 240 minutes | | Paclitaxel | 6.0 mg/ml | > 240 minutes | FORM FDA 3881 (6/20) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ | Paraplatin | 10.0 mg/ml | > 240 minutes | |-----------------------------|------------|---------------| | Pemetrexed | 25.0 mg/ml | > 240 minutes | | Pertuzumab | 30.0 mg/ml | > 240 minutes | | Raltitrexed | 0.5 mg/ml | > 240 minutes | | Retrovir | 10.0 mg/ml | > 240 minutes | | Temsirolimus | 25.0 mg/ml | > 240 minutes | | Thiotepa | 10.0 mg/ml | > 240 minutes | | Topotecan HCI | 1.0 mg/ml | > 240 minutes | | Trisenox (Arsenic Trioxide) | 1.0 mg/ml | > 240 minutes | | Velcade (Bortezomib) | 1.0 mg/ml | > 240 minutes | | Vinblastine | 1.0 mg/ml | > 240 minutes | | Vincristine Sulfate | 1.0 mg/ml | > 240 minutes | | Vinorelbine | 10.0 mg/ml | > 240 minutes | Tested non-chemotherapy drugs and average breakthrough detection time (minutes) are as follows: | Non-Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes | |------------------------|---------------|----------------------------------------| | Cetuximab | 2.0 mg/ml | > 240 minutes | | Chloroquine | 50.0 mg/ml | > 240 minutes | | Cyclosporin A | 100.0 mg/ml | > 240 minutes | | Cytovene (Ganciclovir) | 10.0 mg/ml | > 240 minutes | | Fulvestrant | 50.0 mg/ml | > 240 minutes | | Propofol | 10.0 mg/ml | > 240 minutes | | Rituximab | 10.0 mg/ml | > 240 minutes | | Trastuzumab | 21.0 mg/ml | > 240 minutes | | Triclosan | 2.0 mg/ml | > 240 minutes | | Zoledronic Acid | 0.8 mg/ml | > 240 minutes | Fentanyl Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. Gastric Acid Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes. CAUTION: Testing showed an average breakthrough time of 77.6 minutes with Carmustine. WARNING: Do not use with Carmustine. | 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) | <div> <span> </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." 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