DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 7, 2014 WRP Asia Pacific Sdn. Bhd. Mr. Kirk Penner Head of Department Product Management & Regulatory Affairs Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang. Selangor Darul Ehsan. MALAYSIA 43900 Re: K133168 Trade/Device Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 1, 2014 Received: July 3, 2014 Dear Mr. Penner: 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. {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 (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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K133168 ## Device Name Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile ## Indications for Use (Describe) A 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. 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) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/2/Picture/14 description: The image shows the name "Sreekanth Gutala" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a larger document or label. The background is plain, ensuring the name is easily readable. Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.08.07 13:21:07 -04'00" 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 i he burden instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ #### 1.0 Submitter: | Name: | Mr. Kirk Penner | |------------|------------------------------------------------------------------------------------------------------------------------------------------| | Address: | WRP Asia Pacific Sdn Bhd<br>Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,<br>43900 Sepang, Selangor Darul Ehsan, MALAYSIA | | Phone No.: | +60 3 8706 1486 | | Fax No.: | +60 3 8706 1485 | Date of Summary Prepared: 30 June 2014 #### 2.0 Name of the device: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile Common Name: Exam Gloves Regulatory Class I Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA) #### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed: Dermagrip-N Powder Free Blue Nitrile Examination Gloves 510(k) : K022904 MDL : D036500 Regulatory Class I Product Code : LZA #### 4.0 Description of The Device: Dermagrip Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The Dermagrip powder free blue nitrile patient examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the qloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. #### 5.0 Intended Use of the Device: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finqer to prevent contamination between patient and examiner. {4}------------------------------------------------ # 510(k) SUMMARY #### Summary of the Technological Characteristics of the Device: 6.0 The Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Predicate | Current | | Dimensions | ASTM D6319-10 | Meets | Meets | | Physical Properties | ASTM D6319-10 | Meets | Meets | | Thickness | ASTM D6319-10 | Meets | Meets | | Powder Free | ASTM D6124-06 | Meets<br>≤ 2 mg/glove | Meets<br>≤ 2 mg/glove | | Biocompatibility | Primary Skin<br>Irritation -<br>ISO 10993-<br>10:2010(E) &<br>Consumer Product<br>Safety Commission,<br>Title 16, Chapter II,<br>Part 1500 | Passes<br>(Not a primary<br>skin irritant)<br>The Primary<br>Irritation Index<br>was "0.125". | Passes<br>(Not a primary<br>skin irritant)<br>There was no<br>erythema or<br>oedema noted<br>on test sites<br>after (24±2),<br>(48±2) and<br>(72±2) hours.<br>The Primary<br>Irritation Index<br>(PII) was "0". | | | Dermal Sensitization<br>ISO 10993-<br>10:2010(E) &<br>Consumer Product<br>Safety Commission,<br>Title 16, Chapter II,<br>Part 1500.3(c)(4) | Passes<br>(Not a contact<br>sensitizer)<br>There was no<br>positive allergic<br>reaction<br>observed during<br>the challenge<br>phase (at 24<br>hours and 48<br>hours) among<br>the tested<br>material and<br>the negative<br>control. | Passes<br>(Not a contact<br>sensitizer)<br>There was no<br>positive allergic<br>reaction<br>observed during<br>the challenge<br>phase at (0±2),<br>(24±2) and<br>(48±2) hours in<br>animals treated<br>with the test<br>material and<br>negative<br>control. | {5}------------------------------------------------ # 510(k) SUMMARY | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | |---------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Predicate | Current | | Watertight (1000ml) | ASTM D5151-06 | Passes | Passes | | Intended use | | The powder free<br>blue Nitrile<br>examination<br>glove, non-<br>sterile is a<br>disposable<br>device and is<br>made of<br>synthetic rubber<br>intended for<br>medical<br>purposes that is<br>worn on the<br>examiner's<br>hand or finger<br>to prevent<br>contamination<br>between patient<br>and examiner. | A patient<br>examination<br>glove is a<br>disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's<br>hand or finger<br>to prevent<br>contamination<br>between patient<br>and examiner. | | Material | ASTM D6319-10 | Nitrile | Nitrile | | Color | - | Blue | Blue | | Texture | - | Finger textured | Finger textured | | Size | Medical Glove<br>Guidance Manual -<br>Labeling | Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | | Single Use | Medical Glove<br>Guidance Manual -<br>Labeling | Single use | Single use | | Manufacturer(s) | - | WRP Asia Pacific<br>Sdn Bhd | WRP Asia Pacific<br>Sdn Bhd | There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for thickness. The current device is thinner than the predicate device, however it meets the ASTM standards. {6}------------------------------------------------ ### 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). #### 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 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to the predicate device.