Sterile Polyisoprene Powder Free Surgical Gloves

{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 a stylized image of three human profiles facing to the right, stacked on top of each other. June 22, 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Better Care Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc 2235 E Francis St Ontario. California 91761 Re: K171047 Trade/Device Name: Sterile Polyisoprene Powder Free Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: May 17, 2017 Received: May 17, 2017 Dear Kathy Liu: 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 {1}------------------------------------------------ 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. # Mark S. Fellman -S for 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171047 Device Name Sterile Polyisoprene Powder Free Surgical Gloves Indications for Use (Describe) This surgeon's glove is a sterile and single use device intended to be worn on the hands of operating to protect a surgical wound from contamination. 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) 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}------------------------------------------------ Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 #### 510(K) SUMMARY This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR 807.92. The assigned 510(K) numbers: K171047 #### 1. Owner's Identification: Mrs. Zhu Chunyan Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 Tel:86-311-83601854 Fax: 86-311-83616934 Contact: Ms. Kathy Liu, Project Manager Address: 2235 E Francis St, Ontario CA 91761 Tel:909-590-1611 Fax: 909-673-8347 Date Summary Prepared: March 23, 2017 #### 2. Name of the Device: Trade Name: Sterile Polyisoprene Powder Free Surgical Gloves Common Name: Surgeon's Gloves Classification Name: Surgeon's Gloves Classification Regulation:21 CFR 878.4460 Product Code: KGO Classification Panel: General and Plastic Surgery Device Class: Class I #### 3. Predicate Device Information: Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210, Iselin, NJ 08830 USA Gammex PI Hybrid Surgical Glove (also marketed as Encore PI HybridSurgical Glove) (K 151694) #### 4. Device Description: The subject device is single-use disposable powder-free surgical glove that is supplied {4}------------------------------------------------ Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 sterile and made of polyisoprene. ### 5. Intended for Use: This surgeon's glove is a sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. #### 6. Technological Characteristics: Sterile Polyisoprene Powder Free Surgical Gloves have the following technological characteristics as compared to ASTM or equivalent standards: | Technological Characteristics | Standard/Test/FDA Guidance | Result Summary | |-------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Dimensions | ASTM D3577-09(2015) | Meets ASTM D3577<br>requirements for length, width<br>and thickness | | --Length | Minimum 265mm | Average 305mm | | --Palm Width (size) | (mm) | Average value in mm | | 5½ | 70ଖ | 73 | | 6 | 76ଖ | 79 | | 6½ | 83ଖ | 86 | | 7 | 89ଖ | 91 | | 7½ | 95ଖ | 97 | | 8 | 102ଖ | 105 | | 8½ | 108ଖ | 111 | | 9 | 114ଖ | 117 | | --Thickness | | Average value in mm | | Finger | Minimum 0.10 | 0.22 | | Palm | Minimum 0.10 | 0.20 | | Cuff | Minimum 0.10 | 0.18 | | Physical Properties | ASTM D3577-09(2015) | Meets ASTM D3577-09(2015)<br>requirements for tensile strength<br>and elongation at break before<br>and after accelerated aging | | Tensile Strength, Before<br>Aging | 17MPa, min | Average 19.4MPa | | Ultimate Elongation, Before<br>Aging | 650%, min | Average 823% | | Stress at 500% Elongation | 7.0 MPa, max | Average 2.2MPa | | Tensile Strength, After<br>Accelerated Aging | 12MPa, min | Average 17.1 MPa | | Ultimate Elongation, After<br>Accelerated Aging | 490%, min | Average 748 % | | Freedom from holes | ASTM D3577-09(2015) | Meets ASTM D3577-09 (2015) | {5}------------------------------------------------ Fuqian Xi Road, West district of Shenze Industrial Base, | | ASTM D 5151-06(2015) | and ASTMD5151-06(2015)<br>requirements of AQL1.5 | |-----------------------------------------|---------------------------------------------|-------------------------------------------------------------------| | Powder-Free | ASTM D3577-09(2015)<br>ASTM D 6124-06(2011) | Meets Applicable requirement for<br>Powder Free; ≤ 2 mg per glove | | Sterility | ANSI/AAMI/ISO 11137-1:2006 | Meets ANSI/AAMI/ISO 11137-<br>1:2006 requirement of 10-6 SAL | | Biocompatibility | | | | ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of the study,<br>not an irritant | | ISO Maximization<br>Sensitization Study | ISO 10993-10:2010 | Under the conditions of the study,<br>not a sensitizer | ## 7. Substantial Equivalence: | Substantial Equivalence Comparison Table | | | | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Predicate | Subject Device | Comparison | | Device Class | Class I | Class I | Same | | 510K | K151694 | K171047 | Same | | Product Code | KGO | KGO | Same | | Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | | Regulation Name | Surgeon's | Surgeon's | Same | | Indications for Use | This glove is intended to<br>be worn by operating<br>room personnel to protect<br>a surgical wound from<br>contamination. | This surgeon's glove is a<br>sterile and single use device<br>intended to be worn on the<br>hands of operating room<br>personnel to protect a<br>surgical wound from<br>contamination | Same | | Prescription | Over-The-Counter-Use | Over-The-Counter-Use | Same | | Materials | Synthetic rubber blend of<br>polyisoprene and<br>neoprene | Synthetic polyisoprene<br>rubber | Different | | Design | Single use | Single use | Same | | Sterile | Sterile | Sterile | Same | | Powder-free | Powder-free | Powder-free | Same | | Hand specific | Hand specific | Hand specific | Same | | Beaded cuff | Beaded cuff | Beaded cuff | Same | | Color | White | Clear | Different | | Sterilization Method | Radiation | Radiation | Same | | Sterility Assurance Level<br>(SAL) | 10-6SAL | 10-6SAL | Same | | Shelf Life | 3 years | 3 years | Same | | Dimensions and physical | Meets ASTM D3577-<br>09/2015)requirements | Meets ASTM D3577-<br>09/2015)requirements | Same | | properties | | | | {6}------------------------------------------------ | Freedom from holes | Meets ASTM D3577-<br>09(2015)requirements of | Meets ASTM D3577-<br>09(2015)requirements of | Same | |--------------------|----------------------------------------------|----------------------------------------------|------| |--------------------|----------------------------------------------|----------------------------------------------|------| {7}------------------------------------------------ Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 | | AQL 1.5 | AQL 1.5 | | |------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--| | Powder-Free | Meets Applicable<br>Definition for Powder<br>Free; ≤ 2 mg per glove | Meets Applicable<br>Definition for Powder<br>Free; ≤ 2 mg per glove | | | Biocompatibility | "Under the conditions of<br>the study, not an irritant"<br>and "Under the<br>conditions of the study,<br>not a sensitizer" | "Under the conditions of<br>the study, not an irritant"<br>and "Under the conditions<br>of the study, not a<br>sensitizer" | | The subject device is manufactured from Synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from Synthetic rubber blend of polyisoprene and neoprene with polyurethane polymer inner coating to aid donning. Though the materials of construction differ, the subject device's materials are functionally equivalent to those of the cited predicate. The subject device meets the applicable requirements for surgeon's gloves with regard to dimensions and sizes, physical properties, freedom from holes, powder residues, and protein content as found in the following standards: ASTM D3577-09(2015), ASTM D5151-06(2015) and ASTM D6124-06(2011). The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards. ### 8. Performance Data A clinical study was not conducted on the subject or predicate devices. ### 9. Conclusion: Based on the performed nonclinical test results, the Sterile Polyisoprene Powder Free Surgical Gloves is as safe, as effective, and performs as well as or better than the legally marketed device identified as Gammex PI Hybrid Surgical Glove, which was previously cleared under K151694, Class I (21 CFR 878.4460, Product code KGO).