← Product Code [OPC](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OPC) · K211758 # Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) (K211758) _Hartalega NGC Sdn. Bhd. · OPC · Aug 3, 2021 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OPC/K211758 ## Device Facts - **Applicant:** Hartalega NGC Sdn. Bhd. - **Product Code:** [OPC](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OPC.md) - **Decision Date:** Aug 3, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. ## Device Story Polychloroprene powder-free examination glove; nonsterile; disposable. Worn by healthcare examiners to provide barrier protection against contamination between patient and examiner. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05. Output is physical barrier protection. Used in clinical settings. Benefits include reduced risk of cross-contamination and protection against specific hazardous chemotherapy agents. ## Clinical Evidence Bench testing only. Permeation testing performed per ASTM D6978-05 (Reapproved 2019) for 12 chemotherapy drugs. Breakthrough detection times reported; Carmustine (14.9 min) and Thiotepa (22.9 min) identified as having low permeation times, resulting in contraindication for use with these specific agents. ## Technological Characteristics Material: Polychloroprene. Form factor: Powder-free examination glove. Standards: ASTM D6978-05 (Reapproved 2019) for chemotherapy drug permeation. Nonsterile. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 3, 2021 Hartalega Ngc Sdn. Bhd. Nurul Kong Deputy General Manager-Quality Assurance No.1 Persiaran Tanjung Sepang, Kawasan Perindustrian Tanjung 43900 Malaysia ## Re: K211758 Trade/Device Name: Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZC, OPC Dated: June 3, 2021 Received: June 7, 2021 Dear Nurul Kong: 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. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (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 (OS) 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, Clarence Murray III, 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) K211758 #### Device Name Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) Indications for Use (Describe) Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |---------------------------------------|------------------------------------------------| | Carmustine (3.3 mg/ml) | 14.9 | | Cisplatin (1.0 mg/ml) | >240 | | Cyclophosphamide (20.0 mg/ml) | >240 | | Dacarbazine (10.0 mg/ml) | >240 | | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | | Etoposide (20.0 mg/ml) | >240 | | Fluorouracil (50.0 mg/ml) | >240 | | Methotrexate (25.0 mg/ml) | >240 | | Mitomycin C (0.5 mg/ml) | >240 | | Paclitaxel (6.0 mg/ml) | >240 | | Thiotepa (10.0 mg/ml) | 22.9 | | Vincristine Sulfate (1.0 mg/ml) | >240 | Please note that Carmustine and Thiotepa have extremely low permeation times of 14.9 minutes. Warning: Do not use with Carmustine Warning: Do not use with Thiotepa 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) ## 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!* 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. 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