Powder Free Nitrile Examination Gloves Flock-Lined, Black Color

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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, stacked on top of each other, representing the department's focus on people and health. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 17, 2016 Shen Wei (USA), Inc. % Ms. Cheryl Bailey-Kroll Compliance Manager 33278 Central Ave. Suite 102 Union City, California 94587 Re: K161074 > Trade/Device Name: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 12, 2016 Received: October 18, 2016 Dear Cheryl Bailey-Kroll, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Michael J. Ryan -S for Tina Kiang, Ph.D. 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 510(k) Number (if known) K161074 Device Name Powder-Free Nitrile Examination Glove Flock-Lined, Black Color Indications for Use (Describe) Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. 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/0 description: The image is labeled "Attachment One" and features a logo for "Shen Wei usa inc." The logo includes a green hand graphic above the text. Below the company name is the tagline "PROMOTING YOUR SUCCESS!" in a smaller font size. ## 510(k) Summary #### 1.0 Submitter: | Name: | Shen Wei USA Inc. | |---------------|-------------------------------------------------------| | Address: | 33278 Central Ave. Suite 102<br>Union City, CA. 94587 | | FDA Est Reg#: | 2939388 | | Phone No: | 510-429-8692 | | Fax No: | 510-487-5347 | ### Manufacturer: | Name:<br>Address: | ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD<br>XIZHANG TOWN<br>ZHANGJIAGANG CITY, CHINA 215614 | |-------------------|-----------------------------------------------------------------------------------------------| | FDA Est Reg#: | 1000254914 | | Phone No: | 520-845-0023 | | Fax No: | 520-845-0311 | Date 510k Summary was prepared: October 10, 2016 #### 2.0 Contact Person: | Name: | Cheryl Reep | |-----------|----------------------| | Phone No: | 510-429-8692 | | Fax No: | 510-487-5347 | | Email: | Creep@shenweiusa.com | #### 3.0 Name of the device: | Trade Name: | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | |----------------------|-----------------------------------------------------------------| | Device Name: | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | | Common Name: | Patient Examination Gloves | | Classification Name: | Patient examination glove | | Device Class: | Class 1 | | Regulation Number: | 21 CFR 880.6250 | | Product Code: | 80 LZA | #### 4.0 Predicate Device Information: Device Name: Non Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating Company Name: Siam Sempermed Corp. Ltd. 510K Number: K070639 #### 5.0 Description of the Device: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Non-Sterile, is a disposable device intended for {4}------------------------------------------------ medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. The gloves are lined with cotton flock, ambidextrous with beaded cuff, black colored, single use disposable devices that comes is six sizes (XS, S, M, L, and XL) supplied in non-sterile state. The gloves are made of synthetic rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical and performance characteristics meet all requirements of ASTM D6319-10. Powder was not used for this glove's manufacturing process. #### 6.0 Labeling and Intended Use of the Device: The Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. #### 7.0 Shelf Life or Expiration Data: Not Applicable #### 8.0 Summary of the Technological Characteristics of the Device: The Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is summarized with the following technological characteristics compared to ASTM or equivalent standards. | Characteristics | Standards | Device Performance | |---------------------------------------------|----------------------------------------------------------------|--------------------------------| | Dimensions | ASTM D6319-10 | Meets | | Physical Properties<br>(Before/After Aging) | ASTM D6319-10 | Meets | | Freedom from pinholes | ASTM D6319-10 / ASTM<br>D5151-11 | Meets | | Powder Residual | ASTM D6319-10 | Meets <2mg/glove | | Biocompatibility | ISO 10993-10:2010:<br>i. Primary Skin Irritation<br>in Rabbits | i. Not a primary skin irritant | | | ii. Dermal Sensitization | ii. Not a contact sensitizer | #### 9.0 Device Interior Lining and Manufacturing Process: The Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is sprayed with a white cotton flock on the interior of the glove to help facilitate donning. #### 10.0 Substantial Equivalence Based On Assessment of Non-Clinical Performance Data Comparison to Predicate- The subject device Powder Free Nitrile Examination Gloves Flock-Lined, Black Color compares favorably to the predicate device, Non Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating, as indicated in the tabulated summary below: | Characteristics | Predicate Device | Proposed New Device | Comments | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | Name | Non Sterile, Powder Free<br>Nitrile Examination Glove,<br>Blue with Polymer Coating | Powder Free Nitrile<br>Examination Gloves Flock-<br>Lined, Black Color | N/A | | 510K Number | K070639 | K161074 | N/A | | Company | Siam Sempermed Corp. Ltd. | Shen Wei USA Inc. | N/A | | Device Description/<br>Regulation Number | Patient examination glove /<br>21 CFR 880.6250 | Patient examination glove /<br>21 CFR 880.6250 | Substantially Equivalent | | Product Code | LZA | LZA | Substantially Equivalent | | Intended use | Intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between<br> | Intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. This<br>device is single use only. | Substantially Equivalent | | Instruction for Use | A disposable device<br>intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. This<br>device is single use only. | A disposable device<br>intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. This<br>device is single use only. | Substantially Equivalent | | Non-Sterile | Non-Sterile | Non-Sterile | Substantially Equivalent | | Materials | Nitrile | Nitrile | Substantially Equivalent | | Color | Blue | Black | Difference | | Design | Ambidextrous in different<br>sizes per ASTM 6319-10-<br>dimension requirement | Ambidextrous in different<br>sizes per ASTM 6319-10-<br>dimension requirement | Substantially Equivalent | | Lining / Coating | Polymer Coating | Flock Lining | Difference | | Single Patient Use | Single Patient Use | Single Patient Use | Substantially Equivalent | | Performance: | | | | | I. Freedom from Holes | | | Substantially Equivalent | | II. Dimension | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Substantially Equivalent | | III. Physical Properties | | | Substantially Equivalent | | IV. Powder Residue | | | Substantially Equivalent | | Single Use | Yes | Yes | Substantially Equivalent | | Biocompatibility Test | Passes:<br>i. Primary Skin Irritation<br>Test ii. Dermal Sensitization<br>Test | Passes:<br>i. Not a primary skin irritant<br>ii. Not a contact sensitizer | Substantially Equivalent | # Substantial Equivalence Comparison Table {5}------------------------------------------------ # Summary of Difference and Comparison of Safety and Effectiveness- The subject device differs from the predicate in that: - 1) The subject device is color Black while the predicate device is color Blue. Difference in color does not affect subject device's safety and effectiveness; subject device was tested and met requirements for Biocompatibility and ASTM standards. - 2) The subject device is manufactured with the inner surface coated or lined with flock to facilitate donning. The predicate device is manufactured with the inner surface coated with polymer to assist in donning. Though the materials of construction differ, the subject device's material is functionally equivalent to those of the cited predicate. - Summary of Clinical Testing: Not applicable. No clinical testing was performed. 11. 12. Conclusion: The conclusion drawn from the nonclinical test demonstrate that the subject device, Powder Free Nitrile Examination Gloves Flock-Lined, Black Color, is as safe, as effective, and performs as well as the legally marketed device.