Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs

{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 and 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. October 8, 2020 Encompass Industries Sdn. Bhd. Eunice Yee QA/RA Manager Lot 18256, Kawasan Perindustrian Lot O Kertih Bio-Polymer Park Kemaman, Terengganu 24300 Malaysia Re: K183562 Trade/Device Name: Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZC, LZA Dear Eunice Yee: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 23, 2019. FDA is updating your Indication for Use information due to typos in your Indication for Use. Specifically, the permeation times of Carmustine and Thiopeta were written incorrectly. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact OHT4: Office of Surgical and Infection Control Devices, CAPT Elizabeth F. Claverie, MS, Phone Number 301-796-6298, Email Address: Elizabeth.Claverie@fda.hhs.gov. > Sincerely. Elizabeth F. Claverie -S Elizabeth F. Claverie, MS 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 {1}------------------------------------------------ Image /page/1/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. October 23, 2019 Encompass Industries Sdn. Bhd. Eunice Yee QA/RA Manager Lot 18256, Kawasan Perindustrian Lot O Kertih Bio-Polymer Park Kemaman, 24300 My Re: K183562 Trade/Device Name: Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: September 19, 2019 Received: September 23, 2019 Dear Eunice Yee: 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. {2}------------------------------------------------ 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 medical devices and radiation-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. # Christopher K. Dugard -S For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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) K183562 #### Device Name Powder-Free Nitrile Examination Glove (White Colored, and Black Colored) Tested for Use with Chemotherapy Drugs Indications for Use (Describe) A powder-free patient examination glove 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, the glove was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: The following chemotherapy drugs have been tested with the white glove: | Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes | |----------------------------|---------------|----------------------------------------| | Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | | Doxorubicin Hydrochloride | 2.0mg/ml | > 240 | | Etoposide (Toposar) | 20.0mg/ml | > 240 | | Fluorouracil | 50.0mg/ml | > 240 | | Paclitaxel (Taxol) | 6.0mg/ml | > 240 | | Cisplatin | 1.0mg/ml | > 240 | | Dacarbazine (DTIC) | 10.0mg/ml | > 240 | | *Carmustine (BCNU) | 3.3mg/ml | 11.2 | | *Thiotepa (THT) | 10.0mg/ml | 25.2 | *Please note that the following 2 drugs have extremely low permeation times: - 1. Carmustine: 11.2 minutes - 2. Thiotepa: 25.2 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT). The following chemotherapy drugs have been tested with the blue glove: | Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minute | |----------------------------|---------------|---------------------------------------| | Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | | Doxorubicin Hydrochloride | 2.0mg/ml | > 240 | | Etoposide (Toposar) | 20.0mg/ml | > 240 | | Fluorouracil | 50.0mg/ml | > 240 | | Paclitaxel (Taxol) | 6.0mg/ml | > 240 | | Cisplatin | 1.0mg/ml | > 240 | | Dacarbazine (DTIC) | 10.0mg/ml | > 240 | | *Carmustine (BCNU) | 3.3mg/ml | 10.7 | | *Thiotepa (THT) | 10.0mg/ml | 21.5 | *Please note that the following 2 drugs have extremely low permeation times: 1. Carmustine: 10.7 minutes 2. Thiotepa: 21.5 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT). {4}------------------------------------------------ The following chemotherapy drugs have been tested with the black glove: | Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes | |----------------------------|---------------|----------------------------------------| | Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | | Doxorubicin Hydrochloride | 2.0mg/ml | > 240 | | Etoposide (Toposar) | 20.0mg/ml | > 240 | | Fluorouracil | 50.0mg/ml | > 240 | | Paclitaxel (Taxol) | 6.0mg/ml | > 240 | | Cisplatin | 1.0mg/ml | > 240 | | Dacarbazine (DTIC) | 10.0mg/ml | > 240 | | *Carmustine (BCNU) | 3.3mg/ml | 11.0 | | *Thiotepa (THT) | 10.0mg/ml | 11.1 | *Please note that the following 2 drugs have extremely low permeation times: - 1. Carmustine: 11.0 minutes 2. Thiotepa: 11.1 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT). 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. 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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