Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 2, 2016 Maxter Glove Manufacturing SDN. BHD. Yap Peak Geeh QA & Regulatory Affairs Manager Lot 6070. Jalan Haji Abdul Manan, 6th Miles Off Jalan Meru. Klang, Selangor 41050 MALAYSIA Re: K151390 Trade/Device Name: Powder Free Nitrile Examination Gloves Tested For Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC. LZA Dated: March 25, 2016 Received: March 30, 2016 Dear Yap Geeh: 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. 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 {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. 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) K151390 #### Device Name Powder Free Nitrile Examination Gloves 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 or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) | |------------------------------------------|-----------------------------------------------| | Cisplatin, 1.0mg/ml | >240 | | Cyclophosphamide (Cytoxan), 20mg/ml | >240 | | Carmustine (BCNU), 3.3mg/ml | 1.0 | | Dacarbazine (DTIC), 10.0mg/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 | | Thiotepa, 10.0mg/ml | 31.3 | | Methotrexate ,25mg/ml | >240 | | Mitomycin C, 0.5mg/ml | >240 | | Vincristine Sulfate, 1.0mg/ml | >240 | | Ifosfamide, 50.0mg/ml | >240 | Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml: 1.0 minute Thiotepa, 10.0mg/ml: 31.3 minutes 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. 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for MAXTER Glove Manufacturing SON BHO. The logo features a black panther in front of a gray circle on the left side. To the right of the panther is the word "MAXTER" in large, bold letters, with the words "GLOVE .MANUFACTURING SON BHO" below it. The text "(22°802-H)" is located below the company name, and the text "since 1989" is located in the bottom left corner. Lot 6070, Jalan HaJiAbo ## 1.0 Submitter: | Name | Yap Peak Geeh | |---------------------------|---------------------------------------------------------------------------------------------------| | Address | Lot 6070 Jalan Haji Abdul Manan,<br>6th Miles off Jalan Meru,<br>41050 Klang, Selangor, Malaysia. | | Phone No. | : 6-03-33929888 | | Fax No. | : 60-03-33923328 | | Date of Summary Prepared: | 8th March 2016 | #### 2.0 Name of the device: Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Common Name : Exam Gloves Classification Name: Patient Examination Gloves Speciality ( 21 CFR 880.6250) Product Code LZC, LZA) - 3.0 Identification Of The Legally Marketed Devices that equivalency is claimed: | | Predicate | |-------------------|------------------------------------------------------------------------------------------------------------| | Manufacturer | WRP Asia Pacific Sdn Bhd | | Device Name | Dermagrip Powder Free Blue Nitrile Patient<br>Examination Gloves Tested for Use with<br>Chemotherapy Drugs | | 510(k) Number | K141982 | | Regulation Number | 21 CFR 880.6250 | | Regulatory Name | Patient Examination Glove | | Regulatory Class | I | - 4.0 Description of the Device: These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs. - 5.0 Intended Use of the Device: A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MAXTER GLOVE MANUFACTURING SDN BHD. The logo features a black panther in front of a moon-like circle on the left side. To the right of the panther is the company name in bold, black letters, and below that is the company's full name and registration number. 6.0 Summary of the Technological Characteristics of the Device: Below is the summary of the technological characteristics of the Powder Free Nitrile Examination Gloves compare to ASTM D6319 or equivalent standards. Chemotherapy claim is similar to Predicate, which has a glove thickness below 0.10mm and is shorter than 270mm but complaint with the ASTM standards. Table 1 | Characteristics | Standards | Device Performance | | |----------------------------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Predicate | Current | | Manufacturer | | WRP Asia Pacific<br>Sdn Bhd | Maxter Gloves<br>Manufacturing Sdn Bhd | | 510 (K) Number | | K141982 | K151390 | | Dimensions | ASTM D6319-10 | Min240mm | Min270mm | | Physical Properties | ASTM D6319-10 | Meet | Meet | | Thickness- Finger<br>-palm | ASTM D6319-10 | 0.07-0.10mm<br>0.07-0.09mm | Min0.10mm<br>MinO.10mm | | Freedom From<br>Holes | ASTM D6319-10<br>and ASTM D5151 | Pass | Pass | | Powder Free<br>Residue | ASTM D6319-10<br>and ASTM D6124 | Meet | Meet | | Resistance to<br>Permeation by<br>Chemotherapy<br>Drugs: | ASTM D6978-05 | | | | Test Chemotherapy<br>Drug | Concentration | Minimum Breakthrough Detection Time (min) | | | Cisplatin | 1.0mg/ml | >240 minutes | >240 minutes | | Cyclophosphamide<br>(Cytoxan) | 20mg/ml | >240 minutes | >240 minutes | | Carmustine (BCNU) | 3.3mg/ml | 15.0 | 1.0 minute | | Dacarbazine {DTIC) | 10.0mg/ml | >240 minutes | >240 minutes | | I toposide (Toposar) | 20.0mg/ml | >240 minutes | >240 minutes | | I oxorubicin<br>Hydrochloride | 2.0mg/ml | >240 minutes | >240 minutes | | Fluorouracil | 50.0mg/ml | >240 minutes | >240 minutes | | Paclitaxel (Taxol) | 6.0mg/ml | >240 minutes | >240 minutes | | Thiotepa | 10.0mg/ml | 2.0 minutes | 31.3 minutes | | Methotrexate | 25mg/ml | - | >240 minutes | | Mitomycin C | 0.5mg/ml | - | >240 minutes | | Vincristine Sulfate | 1.0mg/ml | >240 minutes | >240 minutes | | Ifosfamide | 50.0 mg/ml | >240 minutes | >240 minutes | | Warning Statement | | Warning: Please<br>note that the<br>following drugs have<br>extremely low<br>permeation times:<br>Carmustine(BCNU):<br>15 Minutes and<br>Thiotepa: 2 minutes | Warning: Please note that<br>the following drugs have<br>low permeation time of<br>less than 240minutes:<br>Carmustine (BCNU): 1.0<br>Minute and<br>Thiotepa : 31.3 Minutes | | Biocompatibility | Primary Skin<br>Irritation-ISO<br>10993 | Pass | Pass | | | Dermal<br>Sensitization-ISO<br>10993 | Pass | Pass | | Intended Use | - | A patient<br>examination glove is<br>a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient and<br>examiner. | A powder free patient<br>examination glove is a<br>disposable device intended<br>for medical purposes that<br>is worn on the examiner's<br>hands and finger to<br>prevent contamination<br>between patient and<br>examiner.In addition,<br>these gloves were tested<br>for use with chemotherapy<br>drugs in accordance with<br>ASTMD6978-05. | | Material | ASTM D6319-10 | Nitrile | Nitrile | | Texture | - | Finger Textured | Finger Textured | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a black panther in front of a moon. The panther is looking to the right, and the moon is in the background. The text "SINCE 1965" is at the bottom left of the image. The image is a black and white drawing. # MAXTER GIOVE MANUFACTURING SON BHD {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for MAXTER GIOVE MANUFACTURING SON BHO (229862-H). The logo features a black panther in front of a circle on the left side. The text "MAXTER" is in large, bold letters on the right side of the logo. lot 6070, Jaloo Hnji Abdul Manon 6tn Miles Off JalonIJ.eru 4H150 Klang, Sclongo<, Moloysio Tet 603-33929868 {8 ines) Fax: 603-33923328 E-MAIL: m:utcrt'lrn.nct.my 'WYNt.maxter.com.my | Size | Medical Glove<br>Guidance Manual-<br>Labeling | Extra Small | Extra Small | |------------|-----------------------------------------------|--------------|-------------| | | | Small | Small | | | | Medium | Medium | | | | Large | Large | | | | Extra Lar_ge | Extra Large | | Single Use | Medical Glove<br>Guidance Manual-<br>Labeling | Single use | Single use | 7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements). The device and the predicate share the same intended use, same material, same specifications for thickness and length, similar permeation rates for chemotherapy Drugs, similar labeling according to the glove guidance, and same compliance with standards for physical properties, powder free, biocompatibility and watertightness. # 8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Not applicable- Clinical data is not needed for gloves or for most devices cleared by the 510(K) process. #### 9.0 Conclusion Based on intended uses, technological characteristics and non-clinical performance data, the Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs is substantially equivalent to the predicate device K141982.