Non-sterile, Powder-Free Nitrile Examination Glove Black 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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. March 11, 2019 Sri Trang Gloves (Thailand) Co., LTD % M. Jordan Smith Quality Assurance and Regulatory Affairs Leader Sri Trang USA DBA Ventyv 5401 West Kennedy Boulevard, Suite 760 Tampa, Florida 33609-2447 Re: K182241 Trade/Device Name: Non-sterile, Powder-Free Nitrile Examination Glove Black 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, QDO Dated: February 14, 2019 Received: February 14, 2019 Dear M. Jordan Smith: 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Elizabeth F. Claverie -S Digitally signed by Elizabeth F. Claverie -S Date: 2019.03.11 00:18:52 -04'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) ### K182241 #### Device Name Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs Indications for Use (Describe) This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows: - Carmustine (BCNU) 3.3 mg/mL Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL Note that Carmustine(BCNU) and Thiotepa have low permeation times. Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL 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. 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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." {3}------------------------------------------------ # 510(k) Summary [As Required by 21 section 807.92 (c)] K182241 Summary prepared: February 27, 2019 Sri Trang Gloves (Thailand) CO., LTD 10 Soi 10 Phetkasem Rd. Hatyai Songkhla. Thailand 90110 Phone: (+66) 74 344 663 Fax: (+66) 74 344 677 Contact Person - Mr. Anan Pruksanusak, Managing Director Official Correspondent: Sri Trang USA DBA Ventyv™ 5401 West Kennedy Boulevard, Suite 760 Tampa, Florida 33609-2447 Phone: +1 (813) 606-4301 Fax: +1 (813) 606-4314 Contact person - Mr. M. Jordan Smith, Quality Assurance and Regulatory Affairs Leader Device Trade or Proprietary Name - Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs Device Common or Usual Name - Examination glove Device Classification Name - Nitrile Patient Examination Glove (21 CFR 880.6250) Device Product Codes - LZA, LZC, QDO Device Class - Class I Description of the Device - Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs. {4}------------------------------------------------ Intended Use of the Device – This device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. | | TECHNOLOGICAL<br>CHARACTERISTICS | STANDARD | PREDICATE<br>DEVICE<br>K083755 | SUBJECT<br>DEVICE K182241 | COMPARISON | |------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------| | Indications for Use | N/A | This device is a<br>disposable device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner.<br><br>The chemotherapy<br>drugs tested are as<br>follows:<br>Amethopterin<br>Hydrate<br>(Methotrexate),<br>Cisplatin,<br>Cyclphoshamide<br>(Cytoxan),<br>Dacarbazine (DTIC),<br>Doxorubicin<br>Hydrochloride,<br>Etoposide (Toposar),<br>5-Fluoruracil,<br>Paclitazel (Taxol),<br>and Vincristine<br>Sulfate | This device is a<br>disposable device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner.<br><br>The tested<br>chemotherapy drugs<br>are as follows:<br>Carmustine (BCNU)<br>Cisplatin,<br>Cyclophosphamide,<br>Dacarbzine (DTIC),<br>Doxorubicin<br>Hydrochloride,<br>Etoposide (Toposar),<br>Fluorouracil,<br>Methotrexate,<br>Paclitaxel (Taxol),<br>Thiotepa,<br>Vincristine Sulfate<br><br>Note Carmustine<br>(BCNU) and<br>Thiotepa have low<br>permeation times<br><br>Fentanyl tested as<br>follows:<br>Fentanyl Citrate | Nearly Identical | | | Dimensions: overall<br>length | Minimum 230<br>mm | 244 mm | 238 mm<br>238 mm | Identical | | | | ASTM-D<br>6319 | 242 mm<br>242 mm | 238 mm | | | | Dimensions: width<br>(mean) | 110 $ \pm $ 10 mm<br>ASTM-D<br>6319 | Size Large<br>113 mm<br>114 mm<br>114 mm | Size Large<br>114 mm<br>115 mm<br>114 mm | Identical | | | Dimensions: palm and<br>finger thickness | Minimum<br>0.05 mm<br>ASTM-D<br>6319 | Palm<br>0.06 mm<br>0.07 mm<br>0.07 mm<br>Finger<br>0.09 mm<br>0.07 mm<br>0.08 mm | Palm<br>0.07 mm<br>0.07 mm<br>0.07 mm<br>Finger<br>0.08 mm<br>0.08 mm<br>0.09 mm | Identical | | | Tensile strength: before<br>and after aging | Greater than<br>14 MPa<br>ASTM-D<br>6319 | Before<br>40 MPa<br>40 MPa<br>41 MPa<br>After<br>39 MPa<br>40 MPa<br>41 MPa | Before<br>35 MPa<br>33 MPa<br>35 MPa<br>After<br>31 MPa<br>32 MPa<br>34 MPa | Identical | | | Ultimate elongation:<br>before and after aging | Greater than<br>500% Before,<br>400% After<br>ASTM-D<br>6319 | Before<br>564%<br>584%<br>580%<br>After<br>580%<br>580%<br>616% | Before<br>538%<br>534%<br>535%<br>After<br>518%<br>493%<br>503% | Identical | | | Freedom from holes:<br>pinholes AQL 2.5 | Inspection<br>G1, AQL 2.5<br>7 Accept<br>8 Reject<br>ASTM-D<br>6319 | 3<br>2<br>3 | 0<br>2<br>0 | Identical | | | | ASTM-D | 0.5 mg/glove | 0.7 mg/glove | | | | Powder Free Residue | 6319 | 0.3 mg/glove<br>0.2 mg/glove | 0.8 mg/glove<br>0.8 mg/glove | Identical | | | | ISO 10993-5<br><i>In vitro</i><br>cytotoxicity | N/A | Under the conditions<br>of the study, the<br>device extract was<br>found to be<br>cytotoxic and<br>therefore the device<br>extracts were<br>evaluated by ISO<br>10993-11 - Test for<br>systemic toxicity.<br>From the Acute<br>Systemic Toxicity<br>device extracts, the<br>device extracts did<br>not elicit a systemic<br>response in the<br>animal model. | Identical | | | | ISO 10993-11<br>Tests for<br>systemic<br>toxicity | | | | | | Biocompatibility | ISO 10993-10<br>Primary Skin<br>Irritation in<br>Rabbits | Under the conditions<br>of the study, the polar<br>and non-polar device<br>extracts were found<br>not to be an irritant to<br>the animal model. | Under the conditions<br>of the study, the<br>polar and non-polar<br>device extracts were<br>found not to be an<br>irritant to the animal<br>model. | Same | | | | Guinea Pig<br>Sensitization | Under the conditions<br>of the study, the polar<br>and non-polar device<br>extracts were found<br>not to be sensitizers<br>to the animal model. | Under the conditions<br>of the study, the<br>polar and non-polar<br>device extracts were<br>found not to be<br>sensitizers to the<br>animal model. | Same | | Technological Characteristics Comparison Table – {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ Summary of Non-Clinical Performance Testing - Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards: - . ASTM D412-2006a (reapproved 2013) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension - ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration . in an Air Oven - ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions ● - ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in . Medical Gloves - ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on ● Medical Gloves - ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical . Application - ISO 2859 Sampling Procedures and Tables for Inspection by Attributes - ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo ● cytotoxicity - ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and . delaved-type hypersensitivity - ISO 10993-10 Biological evaluation of medical devices-Part 11 Tests for systemic toxicity Conclusion - The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.