POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM

{0}------------------------------------------------ # MAR 1 4 2012 # K 102189 ### 510(k) SUMMARY #### 1.0 Submitter: Latexx Manufacturing Sdn. Bhd. Name: Address: Lot 18374. Kamunting Industrial Estate 34600 Taiping, Perak Malaysia Phone: 605 891 1111 605 829 5590 Fax: Contact Person: Ooi Loon Seng (Madam) Date of Preparation: February 10, 2012 2.0 Name of Device: > Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim Common Name: Examination Gloves Classification Name: Patient Examination Gloves, Specialty Chemotherapy (21 CFR 880.6250 Product Code LZC) 510(k) Number: K102189 Legally Marketed Device to Which Equivalence is being Claimed: 3.0 Primary Predicate: Cardinal Health Esteem Tru-Blu Stretchy Nitrile Exam Gloves 510(k) Number: K032444 Additional Predicate: Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim 510(k) Number: K022765 4.0 Description of the Device: > Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim, meeting all the requirements of ASTM standards D6319-10 and ASTM D6124-06. The gloves are non-sterile, single-use, disposable devices. Additional Information requested 24 February 2012 Page 4 of 10 27 February 2012 {1}------------------------------------------------ #### 5.0 Indications for Use: The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested chemotherapy drugs are as follows: | Test Chemical and Concentration | Average Breakthrough Detection Time (minutes) | |----------------------------------------|-----------------------------------------------| | Cisplatin, 1.0 mg/ml | ≥ 240 | | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 | | Cytarabine, 100 mg/ml | ≥ 240 | | Cytovene, 10 mg/ml | ≥ 240 | | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 | | Docetaxel, 10.0 mg/ml | ≥ 240 | | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 | | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 | | Fluorouracil, 50.0 mg/ml | ≥ 240 | | Ifosfamide, 50.0 mg/ml | ≥ 240 | | Irinotecan Hydrochloride, 20 mg/ml | ≥ 240 | | Mechlorethamine HCI, 1.0 mg/ml | ≥ 240 | | Methotrexate, 25 mg/ml | ≥ 240 | | Mitomycin C, 0.5 mg/ml | ≥ 240 | | Mitoxantrone, 2 mg/ml | ≥ 240 | | Oxaliplatin, 5mg/ml | ≥ 240 | | Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 | | ThioTEPA | 75.8 | | Vincristine Sulfate, 1.0 mg/ml | ≥ 240 | | Vinorelbine, 10 mg/ml | ≥ 240 | | Low Permeation Time (minutes) | 1.7 | | Carmustine (BCNU), 3.3 mg/ml | | Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins) Latexx Manufacturing Sdn. Bhd. Additional Information requested 24 February 2012 Page 5 of 10 27 February 2012 {2}------------------------------------------------ #### 6.0 Summary of Technological Characteristics of the Device: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim have the following technological characteristics compared to ASTM or equivalent standards: | Characteristics | Standard | Device Performance | |---------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Dimensions | ASTM D6319-10 | Meets standard requirements | | Physical Properties | ASTM D6319-10 | Meets standard requirements | | Thickness | ASTM D6319-10 | Meets standard requirements | | Biocompatibility | Primary Skin Irritation<br>Study (ISO 10993-0:2002E)<br>Dermal Sensitization<br>(ASTM-F 720-81) | Passes (Not a primary skin<br>irritant)<br>Passes (Not a contact<br>sensitizer) | | Watertight - 1000 ml<br>(Freedom from Holes) | 21 CFR 800.20 | Passes | | Resistance to Permeation<br>by Chemotherapy Drugs | ASTM D6978-05 | Meets standard requirements | Latexx Manufacturing "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim" demonstrated the following breakthrough detection times when tested according to ASTMD6978-05 | Test Chemical and Concentration | Average Breakthrough<br>Detection Time (minutes) | |---------------------------------------------------------------|--------------------------------------------------| | Cisplatin, 1.0 mg/ml | ≥ 240 | | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 | | Cytarabine, 100 mg/ml | ≥ 240 | | Cytovene, 10 mg/ml | ≥ 240 | | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 | | Docetaxel, 10.0 mg/ml | ≥ 240 | | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 | | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 | | Fluorouracil, 50.0 mg/ml | ≥ 240 | | Ifosfamide, 50.0 mg/ml | ≥ 240 | | Irinotecan Hydrochloride, 20 mg/ml | ≥ 240 | | Mechlorethamine HCl, 1.0 mg/ml | ≥ 240 | | Methotrexate, 25 mg/ml | ≥ 240 | | Mitomycin C, 0.5 mg/ml | ≥ 240 | | Mitoxantrone, 2 mg/ml | ≥ 240 | | Oxaliplatin, 5mg/ml | ≥ 240 | | Paclitaxel (Taxol), 6.0 mg/ml. | ≥ 240 | | Thiotepa | 75.8 | | Vincristine Sulfate, 1.0 mg/ml | ≥ 240 | | Vinorelbine, 10 mg/ml | ≥ 240 | | Low Permeation Time (minutes)<br>Carmustine (BCNU), 3.3 mg/ml | 1.7 | Latexx Manufacturing Sdn. Bhd. Additional Information requested 24 February 2012 Page 6 of 10 27 February 2012 {3}------------------------------------------------ - Substantial Equivalence Based on Assessment of Non-Clinical Performance Data: 7.0 Comparison to Predicate and Non-Clinical Testing - The subject device (Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim) compares favorably to the predicate device (Cardinal Health Esteem Tru-Blu Stretchy Nitrile Exam Gloves) as indicated in the tabulated summaries to follow. ### Substantial Equivalence Comparison of Indications for Use The Indications for Use statements for the subject nitrile gloves and the cited predicate, as listed below, are substantially equivalent (SE). | Indications for<br>Use –<br>Subject Device: | The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy<br>Drugs Labeling Claim is a specialty medical glove which is a disposable device<br>intended for medical purpose that is worn on the examiner's hand or finger to<br>prevent contamination between examiner and patient. In addition these gloves are<br>worn to protect the wearer against exposure to chemotherapy drugs. Tested<br>chemotherapy drugs are as follows: | | |-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | Powder-Free<br>Nitrile<br>Examination<br>Gloves Tested for<br>Use with<br>Chemotherapy<br>Drugs Labeling<br>Claim | Test Chemical and Concentration | Average Breakthrough Detection Time<br>(minutes) | | | Cisplatin, 1.0 mg/ml | ≥ 240 | | | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 | | | Cytarabine, 100 mg/ml | ≥ 240 | | | Cytovene, 10 mg/ml | ≥ 240 | | | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 | | | Docetaxel, 10.0 mg/ml | ≥ 240 | | | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 | | | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 | | | Fluorouracil, 50.0 mg/ml | ≥ 240 | | | Ifosfamide, 50.0 mg/ml | ≥ 240 | | | Irinotecan Hydrochloride, 20 mg/ml | ≥ 240 | | | Mechlorethamine HCI, 1.0 mg/ml | ≥ 240 | | | Methotrexate, 25 mg/ml | ≥ 240 | | | Mitomycin C, 0.5 mg/ml | ≥ 240 | | | Mitoxantrone, 2 mg/ml | ≥ 240 | | | Oxaliplatin, 5mg/ml | ≥ 240 | | | Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 | | | ThioTEPA | 75.8 | | | Vincristine Sulfate, 1.0 mg/ml | ≥ 240 | | | Vinorelbine, 10 mg/ml | ≥ 240 | | | Low Permeation Time<br>(minutes)Carmustine BCNU), 3.3 mg/ml | 1.7 | | Please note that the following drug has an extremely low permeation time: Carmustine<br>(BCNU) 1.7 (mins) | | | Page 7 of 10 27 February 2012 {4}------------------------------------------------ | Indications for Use -<br>Predicate Device: | These examination gloves are disposable devices intended for<br>medical purposes that are worn on the examiner's hands or<br>fingers to prevent contamination between patient and examiner. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cardinal Health Esteem Tru-Blu<br>Stretchy Nitrile Gloves (Nitrile<br>Powder-Free Examination Gloves<br>with Lotion Coating, Blue with<br>Use for Chemotherapy)<br>Cardinal Healthcare<br>Corporation K032444) | In addition, these gloves are worn to protect the wearer against<br>exposure to chemotherapy drugs. | Comparisons of non-clinical biocompatibility and engineering bench tests are included in the summary table below. · | | Subject Device<br>Powder-Free Nitrile<br>Examination Gloves Tested for<br>Use with Chemotherapy Drugs<br>Labeling Claim | Predicate Device<br>Cardinal Health Esteem Tru-<br>Blu Stretchy Nitrile Gloves<br>(Nitrile Powder-Free<br>Examination Gloves with<br>Lotion Coating, Blue with Use<br>for Chemotherapy) | Substantial<br>Equivalence<br>(SE)? | |----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------| | | | Cardinal Healthcare<br>Corporation K032444) | | | Chemotherapy<br>Permeation<br>Standard | Meets ASTM D6978-05 | Meets ASTM D6978-05 | Yes | | Design<br>Specifications &<br>Glove<br>Performance | Meets ASTM D6319-10:<br>-Tensile Strength ≥ 14MPa<br>(≥14MPa per Standard)<br>-Elongation ≥400% (≥400% per<br>Standard) | Meets ASTM D6319-00:<br>-Tensile Strength 19MPa (≥14<br>MPa per Standard)<br>-Elongation 533% (≥400% per<br>Standard) | Yes | | Freedom from<br>Holes | Meets Requirements per<br>21CFR800.20:<br>Gloves Free of Holes at quality<br>level of AQL 1.5 (AQL 2.5<br>required per standard) | Meets Requirements per<br>21CFR800.20:<br>Gloves Free of Holes at quality<br>level of AQL 1.5 (AQL 2.5<br>required per standard) | Yes | | Glove Thickness<br>and Length | Meets ASTM D6319-10:<br>-Palm Thickness of ≥0.10 mm<br>-Finger Thickness ≥0.10 mm<br>-Length ≥270 mm | Meets ASTM D6319-10:<br>-Palm Thickness average 0.10<br>mm<br>-Finger Thickness average 0.13<br>mm<br>-Length average 246 mm | Yes | | Materials | Flexible Nitrile | Flexible Nitrile | Yes | ## Substantial Equivalence Comparison Table – Engineering and Bench Testing Latexx Manufacturing Sdn. Bhd. Additional Information requested 24 February 2012 Page 8 of 10 27 February 2012 {5}------------------------------------------------ ### Substantial Equivalence Comparison Table - Engineering and Bench Testing (continued) | | Subject Device<br>Powder-Free Nitrile<br>Examination Gloves Tested for<br>Use with Chemotherapy Drugs<br>Labeling Claim | Predicate Device<br>Cardinal Health Esteem Tru-<br>Blu Stretchy Nitrile Gloves<br>(Nitrile Powder-Free<br>Examination Gloves with<br>Lotion Coating, Blue with Use<br>for Chemotherapy)<br>Cardinal Healthcare<br>Corporation K032444) | Substantial<br>Equivalence<br>(SE)? | |--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------| | Color | Synthetic Glove with embedded<br>BLUE Biocompatible Colorant | Synthetic Glove with embedded<br>BLUE Biocompatible Colorant | Yes | | Technology of<br>Glove Design,<br>i.e. Coatings<br>and/or Donning<br>Aid | Ambidextrous;<br>Inner Glove Surface Chlorine<br>Treated to Facilitate Donning;<br>Fingertips Textured to Improve<br>Tactility and Grip | Ambidextrous;<br>Lotion Coating on Inner Surface<br>as Donning Aid:<br>Outer Surface Textured to<br>Improve Grip | Yes | | Biocompatibility | Passes tests for :<br>-Primary Skin Irritation<br>-Dermal Sensitization | Passes tests for:<br>-Primary Skin Irritation<br>-Dermal Sensitization | Yes | | Powder-Free | Meets Applicable Definition for<br>Powder Free; < 2 mg per glove | Meets Applicable Definition for<br>Powder Free; ≤ 2 mg per glove | Yes | | Sterility | Not Applicable: Non-Sterile | Not Applicable: Non-Sterile | Yes | Summary of Differences and Comparison of Safety and Effectiveness - The subject device differs from the predicate: Difference in Donning Aid: The predicate device has an inner surface coated with lotion, and the subject device has a chlorine treated inner surface. Both the lotion coating and chlorine treatment serve as donning aids. Therefore, both gloves are functionally equivalent with regard to ease of user donning, and may be used to effectively keep users safe from exposure to chemotherapeutic agents. Difference in Colorant: Latexx Manufacturing incorporates medical grade colorant into the subject device. The subject device has been tested and shown to function as an effective barrier to chemotherapeutic agents. The subject device has also passed biocompatibility tests for skin irritation and dermal sensitization; the subject gloves are non-toxic and may safely contact either users or patients. - 8.0 Animal Testing: No animal testing were required to demonstrate substantial equivalence. - Substantial Equivalence Based on an Assessment of Clinical Performance Data: 9.0 A clinical study was not conducted on the subject or predicate devices. Additional Information requested 24 February 2012 P. 6 of 7 {6}------------------------------------------------ #### 10.0 Conclusion: "Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim" produced by Latexx Manufacturing Sdn. Bhd. are as safe and effective as the predicate device. The subject device has been tested against the applicable ASTM standards listed above, and meets the requirements set forth in those standards. Additional specific comparisons show the subject device substantially equivalent to the predicate. Additional Information requested 24 February 2012 Page 10 of 10 27 February 2012 ., 7 of 7 {7}------------------------------------------------ Image /page/7/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three curved lines representing snakes or branches. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Latexx Manufacturing Sdn. Bhd. C/O Mr. Neil Burris Regulatory Affairs Consultant Reglera, LLC 11925 West 1-70 Frontage Road North, Suite 900 Wheat Ridge, Colorado 80033 MAR 1 4 2012 Re: K102189 > Trade Name: Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim Regulation Number: 21 CFR 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: February 27, 2012 Received: March 14, 2012 Dear Mr. Burris: 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. {8}------------------------------------------------ Page 2- Mr. Burris 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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Anthony D. Watson, B.S., M.S., M.Β.Α. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ## INDICATIONS FOR USE ### Applicant: LATEXX MANUFACTURING SDN. BHD., LOT 18374, Kamunting Industrial Estate, 34600 Taiping, Perak, Malaysia ### 510(k) Number: K102189 ### Device Name: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM Indications For Use: The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is wom on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows: | Test Chemical and Concentration | Average Breakthrough Detection Time (minutes) | |----------------------------------------|-----------------------------------------------| | Cisplatin, 1.0 mg/ml | ≥ 240 | | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 | | Cytarabine, 100 mg/ml | ≥ 240 | | Cytovene, 10 mg/ml | ≥ 240 | | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 | | Docetaxel, 10.0 mg/ml | ≥ 240 | | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 | | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 | | Fluorouracil, 50.0 mg/ml | ≥ 240 | | Ifosfamide, 50.0 mg/ml | ≥ 240 | | Irinotecan Hydrochloride, 20 mg/ml | ≥ 240 | | Mechlorethamine HCI, 1.0 mg/ml | ≥ 240 | | Methotrexate, 25 mg/ml | ≥ 240 | | Mitomycin C, 0.5 mg/ml | ≥ 240 | | Mitoxantrone, 2 mg/ml | ≥ 240 | | Oxaliplatin, 5mg/ml | ≥ 240 | | Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 | | ThioTEPA | 75.8 | | Vincristine Sulfate, 1.0 mg/ml | ≥ 240 | | Vinorelbine, 10 mg/ml | ≥ 240 | | Low Permeation Time (minutes) | 1.7 | | Carmustine (BCNU), 3.3 mg/ml | | Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins) #### Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use Per 21 CFR 801.109 OR Over-The-Counter × Elisha F. Marine-Willen (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: _______________________________________________________________________________________________________________________________________________________________