Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of a stylized representation of human profiles facing to the right. The emblem is positioned in the center of the circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 18, 2017 Better Care Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 2235 E Francis St Ontario. California 91761 Re: K171898 Trade/Device Name: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC. Dated: June 22, 2017 Received: June 26, 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. {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, Tara A. Ryan -S for Lori Wiggins 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) K171898 #### Device Name Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs | Indications for Use (Describe) | | | | | |-------------------------------------------------------------------------------------------------------------------------|--|--|--|--| | This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In | | | | | | addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978. | | | | | | The following chemicals have been tested with these gloves. | | | | | | The tested chemotherapy drugs' breakthrough detection times are listed as follows: | | | | | | Chemotherapy Drug<br>Minimum BDT | | | | | | Carmustine, 3.3 mg/ml 16.0 min. | | | | | | Cisplatin, 1.0 mg/ml<br>>240 min. | | | | | | Cyclophosphamide (Cytoxan) , 20 mg/ml<br>>240 min. | | | | | | Doxorubicin Hydrochloride, 2.0 mg/ml >240 min. | | | | | | Etoposide (Toposar) , 20.0 mg/ml<br>>240 min. | | | | | | Fluorouracil, 50.0 mg/ml<br>>240 min. | | | | | | Methotrexate, 25 mg/ml>240 min. | | | | | | Paclitaxel (Taxol) , 6.0 mg/ml >240 min. | | | | | | Thiotepa, 10.0 mg/ml 16.6 min. | | | | | | Vincristine Sulfate, 1.0 mg/ml >>240 min | | | | | | Please note that the following drugs have extremely low permeation time of less than 30 minutes. Carmustine (3.3 mg/ml) | | | | | | has a minimum breakthrough time of 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 | | | | | Type of Use (Select one or both, as applicable) _ Prescription Use (Part 21 CFR 801 Subpart D) minutes. WARNING: Do not use with Carmustine and Thio-Tepa. > 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) {3}------------------------------------------------ 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." {4}------------------------------------------------ Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 ## 510(K) SUMMARY This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR \$07.92. The assigned 510(K) numbers: K171898 ### 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: August 11, 2017 ## 2. Name of the Device: Trade Name: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs Common Name: Surgeon's Gloves Classification Name: Surgeon's Gloves Classification Regulation: 21 CFR878.4460 Product Code: KGO LZC Classification Panel: General and Plastic Surgery Device Class: Class I #### 3. Predicate Device Information: Medline Industries, Inc. 1 Medline Place, Mundelein, IL 60060 SensiCare PI Surgical Glove (K152428) #### 4. Device Description: The subject device is single-use disposable powder-free surgical glove that is supplied {5}------------------------------------------------ Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 sterile and made of polyisoprene. The gloves have been tested for use with chemotherapy drugs per ASTM D6978. #### 5. Intended for Use: This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978. The following chemicals have been tested with these gloves. The tested chemotherapy drugs' breakthrough detection times are listed as follows: | Chemotherapy Drug | Minimum BDT | |---------------------------------------|-------------| | Carmustine, 3.3 mg/ml | 16.0 min. | | Cisplatin, 1.0 mg/ml | >240 min. | | Cyclophosphamide (Cytoxan) , 20 mg/ml | >240 min. | | Doxorubicin Hydrochloride, 2.0 mg/ml | >240 min. | | Etoposide (Toposar) , 20.0 mg/ml | >240 min. | | Fluorouracil, 50.0 mg/ml | >240 min. | | Methotrexate, 25 mg/ml | >240 min. | | Paclitaxel (Taxol) , 6.0 mg/ml | >240 min. | | Thiotepa, 10.0 mg/ml | 16.6 min. | | Vincristine Sulfate, 1.0 mg/ml | >240 min | Please note that the following drugs have extremely low permeation time of less than 30 minutes. Carmustine (3.3 mg/ml) has a minimum breakthrough time of 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 minutes #### 6. Technological Characteristics: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is substantially equivalent to the predicate, K152428, SensiCare PI Surgical gloves. Both gloves have the same intended use, same material and the same device performance. | Device Characteristic | Predicate Device | Subject Device | Comparison Analysis | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Device Class | Class I | Class I | similar | | 510K | K152428 | K171898 | / | | Product Code | KGO LZC | KGO LZC | similar | | Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | similar | | Regulation Name | Surgeon's | Surgeon's | similar | | Indications for Use | The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In | This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978. | similar | | | | | | | addition, these gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM D6978<br>Standard Practice for Assessment<br>of Medical Gloves to Permeation<br>by Chemotherapy Drugs.<br>Warning: Do not use with<br>Carmustine and Thiotepa | Please note that the following<br>drugs have extremely low<br>permeation time of less than 30<br>minutes. Carmustine (3.3 mg/ml)<br>has a minimum breakthrough<br>time of 16.0 minutes; and<br>Thiotepa (10.0 mg/ml) has a<br>minimum breakthrough time of<br>16.6 min | | | | Size | 51/2, 6, 61/2, 7, 71/2, 8, 81/2, 9 | similar | | | Materials | Polyisoprene | similar | | | Color | Cream colored | similar | | | Dimensions-Length | Meets ASTM D3577<br>270mm min. | similar | | | Dimensions-Width | Meets ASTM D3577<br>51/2-70±6mm<br>6-76±6mm<br>61/2-83±6mm<br>7-89±6mm<br>71/2-95±6mm<br>8-102±6mm<br>81/2-108±6mm<br>9-114±6mm | similar | | | Dimensions-Finger<br>Thickness | Meets ASTM D3577<br>0.10mm min. | similar | | | Dimensions-Palm<br>Thickness | Meets ASTM D3577<br>0.10mm min. | similar | | | Dimensions-Cuff<br>Thickness | Meets ASTM D3577<br>0.10mm min. | similar | | | Physical Properties | Meets ASTM D3577<br>Before Aging<br>Tensile Strength - 17 MPa min<br>Ultimate Elongation – 650% min<br>Stress at 500% Elongation – 7.0<br>MPa min<br>Meets ASTM 3577<br>After Aging<br>Tensile Strength - 12 MPa min<br>Ultimate Elongation – 490% min | similar | | | Freedom from holes | Meets 21 CFR 800.20 and<br>ASTM D3577 when tested in<br>accordance with ASTM D5151<br>Inspection Level 1, AQL 1.5 | similar | | | Powder-Free-Residual<br>Powder | <2mg of residual powder<br>when tested in accordance<br>with ASTM D3577 | similar | | | Sterility Assurance<br>Level (SAL) | 10⁻⁶SAL | 10⁻⁶SAL | similar | | Biocompatibility | "Under the conditions of the<br>study, not an irritant" and<br>"Under the conditions of the<br>study, not a sensitizer" | "Under the conditions of the<br>study, not an irritant" and<br>"Under the conditions of the<br>study, not a sensitizer" | similar | | Chemotherapy Drugs<br>Tested | Carmustine 10.1<br>Cisplatin>240<br>Cyclophosphamide>240<br>Doxorubicin Hydrochloride> 240<br>Etoposide>240<br>Fluorouracil>240<br>Methotrexate>240<br>Paclitaxel>240<br>Thiotepa 11.6<br>Vincristine Sulfate>240<br>Cytarabine>240<br>Dacarbazine >240<br>Ifosfamide >240<br>Mitomycin >240<br>Mitoxantrone >240 | Carmustine, 16.0 Cisplatin,>240<br>Cyclophosphamide>240<br>Doxorubicin Hydrochloride<br>>240<br>Etoposide >240<br>Fluorouracil, >240<br>Methotrexate, >240<br>Paclitaxel >240<br>Thiotepa, 16.6<br>Vincristine Sulfate>240 | similar | | Elements contained on product Labeling | | | | | Product Identifier | Yes | Yes | similar | | Size | Yes | Yes | similar | | Single use only | Yes | Yes | similar | | Country of<br>manufacturing | Yes | Yes | similar | | List of chemotherapy<br>drugs and<br>breakthrough times | Yes | Yes | similar | TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES {6}------------------------------------------------ {7}------------------------------------------------ Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 #### 8.Performance Data 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), ASTM D6124-06(2011) and ASTM D6978. The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards. #### 9. Summary of clinical Testing This section does not apply. No clinical testing was performed. {8}------------------------------------------------ Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 ### 10. Conclusion: The nonclinical testing performed on the Sterile Polyisoprene Powder Free Surgical Gloves, Tested for use with Chemotherapy Drugs demonstrates that this device is as safe, as effective, and performs as well as the predicate device SensiCare PI Surgical Glove, previously cleared under K152428, Class I (21 CFR 878.4460, Product code KGO).