MOTEX POWDER-FREE NITRILE SURGICAL GLOVES

{0}------------------------------------------------ Telephone: 86-21-5979 9888 Fax: 86-21-23010718 ## II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92) ### 2.1. General Information Establishment - E Manufacturer: Shanghai Motex Healthcare Co., Ltd. - li Address: No.369, Jiasong Zhong Road. Huaxin, Qingpu, Shanghai, 201708, China - 동 Owner Number: 9041164 9615978 Registration Number: - 일 Contact Person: Dr. Jen, Ke-Min E-mail: ceirs.jen@msa.hinet.net Tel: 886-3-5208829 : Fax: 886-3-5209783 - Date Prepared: August 1, 2012 ### Device Proprietary Name: Motex Powder-free Nitrile Surgical Gloves Item 6610 White Motex Powder-free Nitrile Surgical Gloves Item 6610 Green - Motex Powder-free Nitrile Surgical Gloves Item 6710 Green - . Common Name: Surgeon's glove - . Classification Name: Surgeon's glove - . Product Code: OCT 0.3 2013 Regulation Number: KGO. Class 1, 878,4460 ### 2.2. Safety and Effectiveness Information #### . Predicate Device: Claim of Substantial Equivalence (SE) is made to Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating (K102500) #### ● Device Description: Motex Powder-free Nitrile Surgical Gloves are made of synthetic rubber. Thev are sterilized by radiation, and intended for be used in surgery for patient and user. #### 9 Device Characteristics: Single use only. Not made with natural rubber latex. #### ● Technological Characteristics: Motex Powder-free Nitrile Surgical Gloves characteristics are summarized below . compared to ASTM and ISO standards to the predicate device: {1}------------------------------------------------ ## SHANGHAI MOTEX HEATHCARE CO., LTD. No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Fax: 86-21-23010718 Telephone: 86-21-5979 9888 | Characteristic | Standard | |-----------------------------------|------------------| | Dimensions | ASTM D 3577-09e1 | | Physical Properties | ASTM D 3577-09e1 | | Freedom from Holes | ASTM D 3577-09e1 | | Water leak testing | ASTM D 5151:2006 | | Residual powder testing | ASTM D 6124-06 | | Water extractable protein testing | ASTM D 5712-10 | | Biocompatibility | ISO10993-10/-12 | | Sterilization Validation | ISO11137-1/-2 | � Powder Residual: > Surgeon's gloves meet powder level requirements for "Powder-free" designation per ASTM D6124. Standard test method for residual powder on medical gloves. The results generated values will below 2mg of residual powder per glove. #### ● Clinical Data: Not applicable. #### � Indications for Use: A surgeon's glove is a sterile and for single use device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. #### . Substantial Equivalence (SE) A claim of substantial equivalence is "Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating" (K102500). Both of the subject device and predicate device have the same indications for use, material composition with Nitrile, meet the performance tests by ASTM D3577, powder residual by ASTM D6124, and also completed the biocompatibility, sterilization validation test reports. The major differences are the subject devices have different colorants for two items, including 6610 White, 6610 Green, and 6710 Green; and the specifications are 6~8.5 size. In addition, the predicate device is made with neoprene and coated with nitrile, while the subject device is made solely with These differences are not relating to the safety or effectiveness nitrile rubber. Thus thev are substantially equivalent. aspects. {2}------------------------------------------------ # SHANGHAI MOTEX HEATHCARE CO., LTD. No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718 # Comparison to Legally Marketed Device | Comparison Feature | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating<br>(K102500) | Motex Powder-free Nitrile Surgical Gloves<br>(K122557) | |----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use | Those powder-free sterile surgeon's gloves are a disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities. | A surgeon's glove is a sterile and for single use device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. | | Prescription/OTC<br>Device | Over-the-Counter Use | Same | | Product code | KGO, Class 1, 878.4460 | KGO, Class I, 878.4460 | | Intended Use | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities. | Sterile disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | | Material<br>Composition | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating | Powder-Free Nitrile Surgical Gloves | | Performance Test<br>for Pinhole,<br>Dimensions, and<br>Physical properties | Meets ASTM D3577 | Same | | Powder Residual | Results generated values below 2mg of residual powder per glove | Meets ASTM D6124<br>Same | | Biocompatibility | Gloves are non-irritating.<br>Gloves do not display any potential for sensitization. | Meets ISO10993-10/-12<br>Same | | Sterilization<br>Method | Irradiation Sterilization | Meets ISO11137-1/-2<br>Same | | Product Trade Name | Sterile Neoprene Powder-Free<br>Surgical Gloves with Nitrile Coating | Motex Powder-free Nitrile Surgical<br>Gloves<br>Item: 6610_White, 6610_Green, and<br>6710 Green | | Device Design | Made with neoprene and coated<br>with nitrile; and it is powder-free<br>and sterile. | Made solely with nitrile rubber; and it<br>is powder-free and sterile. | | Color of the Devices | No prior information | White and Green | | Specification size | No prior information | 6, 6.5, 7, 7.5, 8, 8.5 | | Water Extractable<br>Protein Testing | No prior information | Meets ASTMD5712 | ## Similarity: {3}------------------------------------------------ # SHANGHAI MOTEX HEATHCARE CO., LTD. No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718 ## Difference: . {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains a logo for the Department of Health and Human Services (DHHS) in the USA. The logo features the DHHS emblem, which consists of a stylized human figure with three arms reaching upwards, symbolizing health, services, and people. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Humpshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002 October 3, 2013 Shanghai Motex Healthcare Company, Limited Dr. Jen, Kc-Min Official Correspondent 369 Jiasong Zhong Road Huaxin, Qingpu. Shanghai 201708 CHINA Re: K122557 Trade/Device Name: Motex Powder-free Nitrile Surgical Gloves Item 6610 White Motex Powder-free Nitrile Surgical Gloves Item 6610 Green Motex Powder-free Nitrile Surgical Gloves Item 6710 Green Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: September 18, 2013 Received: September 25, 2013 Dear Dr. Jen: 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 10 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 upproval 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. Iisting 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. {5}------------------------------------------------ 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/MedicalDevices/ResourcesforYou/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/Safetw/ReportalProblem/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, Teiashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### Indications for Use 510 (K) Number ( If Known ):__K122557 Device Name: Motex Powder-free Nitrile Surgical Gloves Item 6610 White Motex Powder-free Nitrile Surgical Gloves Item 6610 Green Motex Powder-free Nitrile Surgical Gloves Item 6710 Green Indications for Use: A surgeon's glove is a sterile and for single use device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. Prescription Use (21 CFR Part 801 Subpart D) AND/OR ਵ Over the Counter Use __ (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elizabeth F. Claverie 2013.10.02 17:29:07 -04'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) __K122557 Page_ 1 of _1