PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)

{0}------------------------------------------------ # R101436 ## 510(k) SUMMARY #### 1.0 Submitter NOV 1 7 2010 Name Street Address Phone No. Fax No. Shen Wei (USA) Inc. 33278 Central Ave., Suite 102 Union City, CA. 94587 (510)429-8692 (510)487-5347 x No. (St # Date of Summary Prepared: 08/12/10 Prepared by: Albert Li #### 2.0 Name of the device: Glove Proprietary or Trade Name: Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs ### Common Name: Exam gloves Classification Name: Patient examination glove, Specialty Chemotherapy (per 21 CFR 880.6250 product code LZC) Classification Information: Class I Nitrile patient examination glove 80LZC, powder-free and meeting all the requirements of ASTM D 6319-00a-05 and is tested with chemotherapy drugs according to ASTM D 6978-05. #### Identification of the Legally Marketed Device: 3.0 : Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera Regulatory Class I Nitrile patient examination Product code: 80LZA 510(k): K092411 #### 4.0 Description of the Device: Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs meets all the requirements of ASTM D 6978-05, ASTM D6319-00a(2005) and FDA 21 CFT 880.6250. #### રું... Intended Use of Device: Product: Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs 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. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, {1}------------------------------------------------ # KIDI436 Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin) | Chemotherapy Drug Permeation (Breakthrough Detection Time) in Min | | |-------------------------------------------------------------------|-------| | The following chemicals have been tested with these gloves. | | | Cyclophosphamide | >240 | | Doxorubicin HCl (Adriamycin) | >240 | | *Carmustine | 0.68 | | Etoposide | >240 | | Fluorouracil (Adrucil) | >240 | | Paclitaxel (Taxol) | >240 | | *ThioTEPA | 34.21 | | Dacarbazine | >240 | | Cisplatin | >240 | Please note that the following drug have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 0.68 minutes. Please note that the following drug have extremely low permeation times of less than 60 minutes, Thiotepa has an average breakthrough time of 34.21 minutes. #### 5.1 Intended Use of Device: Product: Blue with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs 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. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin) | Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. | | | | |------------------------------------------------------------------------|-------|--|--| | The following chemicals have been tested with these gloves. | | | | | Cyclophosphamide | >240 | | | | Doxorubicin HCl (Adriamycin) | >240 | | | | *Carmustine | 2.10 | | | | Etoposide | >240 | | | | Fluorouracil (Adrucil) | >240 | | | | Paclitaxel (Taxol) | >240 | | | | *ThioTEPA | 27.17 | | | | Dacarbazine | >240 | | | | Cisplatin | >240 | | | Please note that the following drugs have extremely low permeation times of fess than 30 minutes, Carmustine has an average breakthrough time of 2.10 minutes. Thiotepa has an average breakthrough time of 27.17 minutes. 2 {2}------------------------------------------------ #### Summary of Technological Characteristics for Modified Device: 6.0 Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe -Vera, Tested-for-use-with-Chemotherapy-Drugs are summarized with.the following technological characteristics compared to ASTM or equivalent standards. | Characteristics | Standards | Device Performance | |---------------------------------------------------|------------------------------------|-----------------------------------------| | Dimensions | ASTM D 6319-00a05 | Meets | | Physical Properties | ASTM D 6319-00a05 | Meets | | Freedom from pinholes | ASTM D 5151-06 | Meets (AQL 2.5) | | Powder Residual | ASTM D 6124-06 | Meets (<2mg/glove) | | Biocompatibility | Primary Skin Irritation in Rabbits | Passes<br>(Not a primary skin irritant) | | Biocompatibility | Dermal Sensitization | Passes<br>(Not a primary skin irritant) | | Resistance to permeation<br>by Chemotherapy Drugs | ASTM D6978-05 | Meets | All other characteristics including appearance, thickness, material, physical properties are equivalent to the predicate device. This 510(k) submission is to seek approval for the device to be marketed with the ASTM D6978-05 claim on resistance to permeation by chemotherapy drugs. | Characteristic and | Shen Wei USA | Shen Wei USA | Substantial | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | parameters | INC. (New Device) | INC. K032024 | Equivalence (SE) | | Product Code | LZA | LZA | SE | | Intended Use | A disposable device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. This<br>device is<br>single use only.<br>Tested for use with<br>chemotherapy<br>drugs. Tested<br>chemotherapy<br>drugs are as follows<br>(Fluorouracil,<br>Etoposide,<br>Cyclophosphamide,<br>Carmustine, Thio- | A disposable device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. This<br>device is<br>single use only.<br>(Tested for use with<br>chemotherapy<br>drugs). | SE | #### Substantial Equivalence Discussion: 7.0 {3}------------------------------------------------ KID1436 4 | | Tepa, Paclitaxel,<br>Doxorubicin<br>Hydrochloride,<br>Dacarbazine,<br>Cisplatin) | | | | |-----------------------|----------------------------------------------------------------------------------|--------|----|--| | Width (size | 95mm | 95mm | SE | | | Medium) | | | | | | Overall Length | 240mm | 240mm | SE | | | Palm Thickness | 0.19mm | 0.19mm | | | | Finger Thickness | 0.21mm | 0.21mm | | | | Tensile strength pre- | 19 MPa | 19 MPa | | | | aging min | | | | | | Tensile strength | 20 MPa | 20 MPa | SE | | | after aging min | | | | | | Ultimate elongation | 550% | 550% | | | | pre-aging min. | | | | | | Ultimate elongation | રરુજરાજ | 550% | | | | after aging min | | | | | | Meets | yes | YES | | | | Biocompatibility | | | | | | Skin irritation test | Passes | Passes | SE | | | Dermal sensitization | Passes | Passes | | | #### 8.0 Conclusion: Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs will perform according to the glove performance standards reference in section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices. Albert Li, Project Manager {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Albert Li Project Manager Shen Wei (USA), Incorporated 33278 Central Avenue, Suite 102 Union City, California 94587 NOV 17 2010 Re: K101436 Trade/Device Name: Red & Blue with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera. Tested for use with Chemotherapy Labeling Claims Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA / LZC Dated: October 18, 2010 Received: October 28, 2010 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 notmean 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, Sincerely yours, Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ### Enclosure {6}------------------------------------------------ # K101436 1-A. Indiction for Use # INDICATION FOR USE Shen Wei (USA) Inc. Applicant: NOV 1 7 2010 - Device Name: Blue with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera. Tested for use with Chemotherapy Drugs ## 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. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin) | Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. | | |------------------------------------------------------------------------|-------| | The following chemicals have been tested with these gloves. | | | Cyclophosphamide | >240 | | *Carmustine | 2.10 | | Doxorubicin HCl (Adriamycin) | >240 | | Etoposide | >240 | | Fluorouracil (Adrucil) | >240 | | Paclitaxel (Taxol) | >240 | | *ThioTEPA | 27.17 | | Dacarbazine | >240 | | Cisplatin | >240 | Please note that the following drugs have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 2.10 minutes. Thiotepa has an average breakthrough time of 27.17 minutes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Elaine S. Manhall OFF) for SFC Infection Control, Dent **Prescription Use** FR 001-100 Per 21CFR 801.109 510(k) Number: K {7}------------------------------------------------ # 1-B. Indiction for Use_ # INDICATION FOR USE NOV 1 / 2010 Applicant: Shen Wei (USA) Inc. - Device Name: Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs ## 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. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin) | Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. | | |------------------------------------------------------------------------|-------| | The following chemicals have been tested with these gloves. | | | Cyclophosphamide | >240 | | Doxorubicin HCl (Adriamycin) | >240 | | *Carmustine | 0.68 | | Etoposide | >240 | | Fluorouracil (Adrucil) | >240 | | Paclitaxel (Taxol) | >240 | | *ThioTEPA | 34.21 | | Dacarbazine | >240 | | Cisplatin | >240 | Please note that the following drug have extremely low permeation times of less than 30 minutes. Carmustine has an average breakthrough time of 0.68 minutes. Please note that the following drug have extremely low permeation times of less than 60 minutes, Thiotepa has an average breakthrough time of 34.21 minutes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Elaine S. Mayhall Prescription Use Per 21CFR 801.109 510(k) Number: