POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE

{0}------------------------------------------------ k132354 510(K) summary Page 1 of 5 ### 510(k) SUMMARY # JUN 3 0 2014 #### 1.0 Submitter: | Name: | Mr. Francis V | |------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Advanced Healthcare Products Sdn Bhd<br>Lot 60 & 61, Lorong Senawang 3/2,<br>Senawang Industrial Estate,<br>70450 Seremban, Negeri Sembilan Darul Khusus,<br>Malaysia. | | Phone No.: | +60 6 678 4188 | | Fax No.: | +60 6 678 4727 | Date of Summary Prepared: June 27, 2014 LZA) #### 2.0 Name of the device: Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile Common Name: Patient Examination Glove Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code Regulatory Class I #### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed: Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile (and various brandnames) 510(k) : K110979 MDL : D133849 Regulatory Class I Product Code : LZA #### 4.0 Description of The Device: | Predicate<br>K110979 | Current<br>K132354 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dermagrip Ultra Powder Free Blue<br>Nitrile Patient Examination Gloves<br>Non-Sterile (and various brandnames)<br>meets all the requirements of ASTM<br>standard D6319-10 and FDA 21 CFR<br>880.6250. | Powder Free Blue Nitrile Patient<br>Examination Glove, Non-Sterile meets<br>all the requirements of ASTM standard<br>D6319-10 and FDA 21 CFR 880.6250. | | | The powder free nitrile examination<br>glove is manufactured from synthetic<br>rubber latex. Inner surface of gloves<br>undergo surface treatment process to<br>produce a smooth surface that assists<br>the user in donning the gloves with ease<br>without using any lubricant such as<br>powder on the glove surface. The glove<br>is ambidextrous; i.e. can be worn on<br>right hand or left hand. | {1}------------------------------------------------ #### 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 finger to prevent contamination between patient and examiner. #### 6.0 Summary of the Technological Characteristics of the Device: The Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Predicate<br>K110979 | Current<br>K132354 | | Dimensions | ASTM D6319-10 | Meets | Meets<br>Length min 230mm<br>Width min 95±10 | | Physical Properties | ASTM D6319-10 | Meets | Meets<br><br>Before Aging<br>Tensile Strength<br>min 14 MPa<br>Ultimate Elongation<br>Min 500%<br><br>After Aging<br>Tensile Strength min 14<br>MPa<br>Ultimate Elongation<br>Min 400% | | Thickness | ASTM D6319-10 | Meets | Meets<br>Finger min 0.05mm<br>Palm min 0.05mm | | Powder Free | ASTM D6124-06<br>(Reapproved 2011) | Meets<br>≤ 2 mg/glove | Meets<br>≤ 2 mg/glove | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | | | Predicate<br>K110979 | Current<br>K132354 | | Biocompatibility | Primary Skin<br>Irritation -<br>ISO 10993-<br>10:2010(E) &<br>Consumer Product<br>Safety Commission,<br>Tittle 16, Chapter<br>II, Part 1500 | Passes<br>(Not a primary<br>skin irritant)<br>There was no<br>erythema or<br>oedema noted on<br>abraded or non-<br>abraded sites at<br>$24\pm1$ hours and<br>$72\pm1$ hours. The<br>Primary Irritation<br>Index (PII) of test<br>material was "0". | Passes<br>(Not a primary skin<br>irritant)<br>There was no<br>erythema or oedema<br>noted on abraded or<br>non-abraded sites at<br>$24\pm1$ hours and $72\pm1$<br>hours. The Primary<br>Irritation Index (PII)<br>of test material was<br>"0". | | | Dermal<br>Sensitization -<br>ISO 10993-<br>10:2010(E) &<br>Consumer Product<br>Safety Commission,<br>Tittle 16, Chapter<br>II, Part<br>1500.3(c)(4) | Passes<br>(Not a contact<br>sensitizer)<br>There was no<br>positive allergic<br>reaction observed<br>during the<br>challenge phase<br>(at $0\pm2$ , $24\pm2$<br>hours and $48\pm2$<br>hours) in animals<br>treated with the<br>test material and<br>negative control. | Passes<br>(Not a contact<br>sensitizer)<br>There was no positive<br>allergic reaction<br>observed during the<br>challenge phase (at<br>$0\pm2$ , $24\pm2$ hours and<br>$48\pm2$ hours) in<br>animals treated with<br>the test material and<br>negative control. | | Watertight (1000ml) | ASTM D5151-06<br>(Reapproved 2011) | Passes | Passes<br>AQL 2.5 | | Intended Use | | The powder free<br>examination glove<br>is a specialty<br>medical glove<br>which is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on<br>the examiner's<br>hand or forefinger<br>to prevent<br>contamination<br>between examiner<br>and patient bodily<br>fluids, waste or<br>environment. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | | CHARACTERISTICS STANDARDS | | DEVICE PERFORMANCE | | | | | Predicate<br>K110979 | Current<br>K132354 | | Material | ASTM D6319-10 | Nitrile | Nitrile<br>Sulphur<br>Zinc Oxide<br>Zinc<br>Dibutyldithiocarbamat<br>e (ZDBC)<br>Zinc<br>Diethyldithiocarbamate<br>(ZDEC).<br>Phenolic Antioxidant<br>Titanium Dioxide<br>Blue Pigment | | 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) | - | Advance Medical<br>Products Sdn Bhd | Advanced Healthcare<br>Products Sdn Bhd | {2}------------------------------------------------ ﻢ ﺍﻟﻤﺴﻬ AHP 510K Summary K132354 Page 3 of 5 {3}------------------------------------------------ #### 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. {4}------------------------------------------------ #### 9.0 Conclusion The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device. Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile will perform according to the gloves performance standards such as ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles an abstract bird or eagle in flight, composed of three curved lines. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 30, 2014 Advanced Healthcare Products Sdn Bhd Mr. Francis V Operations Manager Lot 60 & 61, Lorong Senawang 3/2 Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus, MALAYSIA Re: K132354 · Trade/Device Name: 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: May 20, 2014 Received: May 22, 2014 Dear Mr. Francis V: We have reviewed your Section 510(k) promarket 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 docs 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. {6}------------------------------------------------ ### Page 2 - Mr. Francis V 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDeyices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purofitt-Sheth, M.D. Cliaical 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 {7}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ### Indications for Use 510(k) Number (if known) K 132354 #### Device Name Powder Free Blue Nitrile Patient Examination Glove 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) 0 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) # Sreekanth Gutala .. :: . Digitally signed by Sreekanth Gutala -5 DN; coUS, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -5 Date: 2014,06.23 13:54:11 -04Y00' 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 lime 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. Send comments regarding this burden established to be 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." FORM FDA 3881 (1/14)