POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR

{0}------------------------------------------------ K12/528 33278 Central Ave., #102 Union City, CA 94587, USA T. 510.429.8692 F. 510.487.5347 TOLL FREE.1.888.988.8788 ## 510(k) Summary ## 1.0 Submitter/ 510(k) Owner: Name: Address: Shen Wei USA Inc. 33278 Central Ave. Suite 102 Union City, CA. 94587 Phone No: 510-429-8692 Fax No: 510-487-5347 # Manufacturer: Name: ZHANGJIAGANG JIAMEI RUBBER PRODUCTS CO., LTD Address: FENGHUANG TOWN, ZHANGJIAGANG CITY, CHINA 215614 Phone No: 520-845-0023 Fax No: 520-845-0311 Date 510k Summary was prepared: August 7th, 2012 ### 2.0 Contact Person: | Name: | Albert Li | |-----------|--------------| | Phone No: | 510-429-8692 | | Fax No: | 510-487-5347 | #### 3.0 Name of the device: | Trade Name: | Powder-Free Blue Nitrile Examination Gloves Peppermint<br>Scented | |----------------------|-------------------------------------------------------------------| | Device Name: | Powder-Free Blue Nitrile Examination Gloves Peppermint<br>Scented | | Common Name: | Patient Examination Gloves | | Classification Name: | Patient examination glove (21 CFR 880.6250, Product<br>Code FMC) | | Product Code: | Nitrile -80LZA | ## Predicate Device Information: 4.0 Image /page/0/Picture/16 description: The image shows a logo for Shen Wei USA Inc. The logo features a black hand above the company name, with the words "PROMOTING YOUR SUCCESS!" underneath. The website address, www.shenweiusa.com, is also included at the bottom of the logo. SEP 11 2012 {1}------------------------------------------------ The predicate device is K090194, Powder-Free Nitrile Examination Gloves, Black Color, 07/07/2009. Class I Powder Free Nitrile Examination gloves, 80LZA, that meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. ### Description of The Device: 5.0 The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile. #### 6.0 Labeling and Intended Use of the Device: Draft labels for Powder-Free Blue Nitrile Examination Gloves Peppermint Scented, can be found in Attachment 3. The Powder-Free Nitrile Examination Gloves, Peppermint Scented, Blue 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. Indication for Use Statement can be found in Attachment 4. ### 7.0 Summary of the Technological Characteristics of the Device The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented, are summarized with the following technological characteristics compared to ASTM or equivalent standards. | Characteristics | Standards | Device Performance | |-----------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------| | Dimensions | ASTM D6319-10 | Meets | | Physical Properties | ASTM D6319-10 | Meets | | Freedom from pinholes | ASTM D6319-10<br>FDA 21 CFR 800.20 | Meets, AQL 2.5 | | Powder-Free | ASTM D 6124-06 | Meets < 2mg/glove | | Biocompatibility | Primary Skin Irritation in<br>Rabbits<br>Dermal Sensitization | Passes<br>(Not a primary skin irritant)<br>Passes (Not a contact<br>sensitizer) | The test methods used are the same as those submitted in the original submission. ## Substantial Equivalent Based on Assessment of Non-Clinical Performance 8.0 Data The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned in section 7.0. A summary of the {2}------------------------------------------------ non-clinical performance data showing substantial equivalence to predicate device is presented in the table below: # Comparison with Predicate Device | Characteristic<br>and<br>Parameters | Powder-Free Nitrile<br>Examination Gloves, Blue with<br>Peppermint Scent (New<br>Device) | Powder-Free Nitrile<br>Examination Gloves, Black<br>Color (K090194 -Predicate) | Substantial<br>Equivalence<br>(SE) | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | Product Code | 80 LZA | 80 LZA | SE | | Color: | Blue | Black | SE | | Compound: | Nitrile | Nitrile | SE | | Labeling | See Attachment 2 (new) | See Attachment 2 (predicate) | SE | | Intended Use | A disposable device intended for<br>medical purpose that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. This device is<br>single use only. | A disposable device intended<br>for medical purpose that is<br>worn on the examiner's hand<br>to prevent contamination<br>between patient and examiner.<br>This device is single use only. | SE | | Width<br>(Medium) | 95 mm | 95 mm | SE | | Length | 240 mm | 240 mm | SE | | Single Palm<br>Thickness | 0.09 mm | 0.09 mm | SE | | Single Finger<br>Thickness | 0.10 mm | 0.10 mm | SE | | Single Cuff<br>Thickness | 0.08 mm | 0.08 mm | SE | | Tensile<br>strength pre-<br>aging (ASTM<br>D412) | 25 MPa | 25 MPa | SE | | Tensile<br>strength after<br>aging (ASTM<br>D412) | 25 MPa | 25 MPa | SE | | Water Leak<br>Testing (ASTM<br>D5151) | Water Leakage checked to AQL<br>2.5 | Water Leakage checked to AQL<br>2.5 | SE | | Ultimate<br>elongation<br>pre-aging<br>(ASTM D412) | 592% | 570% | SE | | Ultimate<br>elongation<br>after aging<br>(ASTM D412) | 572% | 577% | SE | | Skin Irritation<br>Test | Pass | Pass | SE | | Dermal<br>Sensitization | Pass | Pass | SE | | Residual<br>Powder (ASTM<br>D6124) | < 2mg/glove | < 2mg/glove | SE | {3}------------------------------------------------ ## Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0 Clinical data is not needed for gloves. ## 10.0 Conclusion: The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented, will perform according the glove performance standards referenced in section 7.0 above and meet ASTM standards, and FDA requirements for water leak.test on pinhole AQL. Also, this device is substantial equivalent in safety and performance to currently marketed devices. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Albert Li Director of Special Projects & Compliance Shen Wei USA. Incorporated 33278 Central Avenue, Suite 102 Union City, California 94587 EP 11 2012 Re: K121528 Trade/Device Name: Powder-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 20, 2012 Received: July 25, 2012 Dear Mr. Li: 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. {5}------------------------------------------------ ## Page 2- Mr. Li 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Resourcesfor You/Industry/default.htm. Sincerely yours. For Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ## Enclosure {6}------------------------------------------------ KI21528 # Attachment Two # INDICATION FOR USE Applicant: Shen Wei (USA) Inc. Device Name: Powder-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color Indication For Use: 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. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use Per 21CFR 801.109 OR Over-The Counter X (Optional Format 1-2-96) 7 AD. But m.D. (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K121528