Powder Free Nitrile Examination Glove

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 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 an abstract symbol resembling a stylized caduceus, with three human profiles forming the staff of the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 8, 2017 Professional Latex Sdn Bhd Mr. Terence Lim Regulatory Affairs Manager Lot 52. Jalan Logam 2. Kamunting Raya Industrial Kamunting, 34600 MY Re: K171667 Trade/Device Name: Powder Free Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: August 10, 2017 Received: August 10, 2017 Dear Mr. Terence Lim: 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 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 {1}------------------------------------------------ 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 Industry and Consumer Education (DICE) 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 (DICE) 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, # Lori A. Wiggins -S6 Lori A. Wiggins, MPT, CLT 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K171667 Device Name Powder Free Nitrile Examination Glove 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 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 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)#: K171667 ### 510 (K) SUMMARY - 2.0 Submitter 1.0 Professional Latex Sdn Bhd Lot 52, Jalan Logam 2, Kamunting Raya Industrial 34600 Kamunting, Perak | Tel: | +605 - 891 1637 | |---------------------------|-----------------------------------| | Fax: | +605 - 891 1417 | | Name of Contact Person: | Terence Lim | | Email Address: | Terencelim @professionallatex.com | | Date of Summary Prepared: | September 3, 2017 | #### 3.0 Name of Device: | Trade Name: | Powder Free Nitrile Examination Glove | |------------------------|---------------------------------------| | Classification Name: | Polymer Patient Examination Glove | | Device Classification: | I | | Regulation Number: | 21 CFR 880.6250 | | Panel: | General Hospital | | Product Code: | LZA | #### 4.0 Identification of The Legally Marketed Device Predicate Device Name: RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) Predicate 510(K) Number: K100603 Manufacturer's Name: Riverstone Resources Sdn Bhd Jalan Jasmin 2 48300 Bukit Beruntung #### 5.0 Description of Device Non-Sterile, Powder Free Nitrile Examination Gloves - Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for overthe counter single use. #### 6.0 The Intended Use of Glove A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. {4}------------------------------------------------ - 7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for Substantial Equivalent Discussion. There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Nitrile Examination Gloves, Blue, has the below technological characteristic compared to ASTM or Equivalent standards. | Characteristics<br>and Parameters | Powder Free Nitrile<br>Examination Gloves<br>(K171667) | Powder Free Nitrile<br>Examination Gloves<br>(K100603) | Comparison | |----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Product Code | LZA | LZA | Same product<br>Code | | Intended Use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | Same Intended<br>Use | | Classification | Class I | Class I | Same | | Raw Rubber<br>Material | Nitrile (Acrylonitrile-<br>butadiene) | Nitrile (Acrylonitrile-<br>butadiene) | Same | | Surface<br>Appearance | 1.Blue<br>2. Ambidextrous<br>3.Finger Textured | 1.Blue<br>2. Ambidextrous<br>3.Finger Textured | Similar | | Overall Length<br>Minimum 230mm | Average: 242 mm | 240 – 250 mm<br>(specification sheet) | Similar | | Width<br>S : 75mm - 95mm<br>M: 85mm - 105mm<br>L:100mm - 120mm | Average:<br>S: 85mm<br>M: 95mm<br>L: 104mm | S : 83 - 86 mm<br>M : 93 - 96 mm<br>L : 102 - 105 mm<br>(specification Sheet) | Similar | | Palm Thickness<br>(Minimum 0.05mm) | Average:<br>0.06mm | 0.07 - 0.09 mm<br>(specification sheet) | Similar | | Characteristics and<br>Parameters | Powder Free Nitrile<br>Examination Gloves<br>(K171667) | Powder Free Nitrile<br>Examination<br>Gloves (K100603) | Comparison | | Finger Thickness<br>(Minimum 0.05mm) | Average: 0.07mm | 0.10 - 0.13 mm<br>(specification sheet) | Similar | | Tensile Strength<br>(before age)<br>Minimum 14 MPa | Average: 17.44 MPa | More than 17 MPa<br>(Specification Sheet) | Similar | | Tensile Strength<br>(After Age)<br>Minimum 14 MPa | Average: 16.37 MPa | More than 16 MPa<br>(Specification Sheet) | Similar | | Ultimate Elongation<br>before age<br>(Minimum 500%) | Average: 559% | 500% - 600%<br>(Specification Sheet) | Similar | | Ultimate Elongation<br>after age<br>(Minimum 400%) | Average: 508% | 400% - 500%<br>(Specification Sheet) | Similar | | Freedom of Holes<br>Meet AQL 2.5 at G1 | Meet AQL 1.5 with G1 | Meet AQL 1.5 with<br>G1. | Same | | Residual powder test<br>(Less than<br>2mg/glove) | Average powder<br>residue for each size:<br>S: 0.43 mg/glove<br>M: 0.31 mg/glove<br>L: 0.47 mg/glove | Contained less than<br>2mg/glove | Similar | | Primary Skin<br>Irritation | Under the conditions<br>of study, not an<br>irritant | Under the conditions<br>of study, not an<br>irritant | Same | | Dermal Sensitization | Under the conditions<br>of study, not a<br>sensitizer | Under the conditions<br>of study, not a<br>sensitizer. | Same | {5}------------------------------------------------ # Professional Latex Sdn Bhd Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak #### 8.0 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). #### 9.0 Clinical Performance Data Not applicable - Clinical data is not needed for gloves - 10.0 Conclusion Powder Free Nitrile Patient Examination Glove, Non-Sterile is as safe and as effective and substantially equivalent to the predicate device.