Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs

{0}------------------------------------------------ Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble water or fabric. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 21, 2016 Shandong Baisheng Medical Products Co., Ltd. % John Zhao Official Correspondence Basic Medical Industries, Inc. 805 Barrington Ave Ontario, California 91764 Re: K161944 Trade/Device Name: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: October 7, 2016 Received: October 19, 2016 Dear John Zhao: 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 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 {1}------------------------------------------------ the quality systems (OS) 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. Michael J. Ryan -S for Tina Kiang, Ph.D. 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) K161944 Device Name Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs #### Indications for Use (Describe) A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | | Chemotherapy Drug and<br>Concentration | Minimum Breakthrough Detection<br>Time ( Minutes ) | |-----|----------------------------------------|----------------------------------------------------| | 1. | Carmustine (BCNU) (3.3 mg/ml) | 13.6 | | 2. | Cisplastin, (1.0 mg/ml) | >240 | | 3. | Cyclophosphamide (20 mg/ml) | >240 | | 4. | Doxorubicin HCl (2.0 mg/ml) | >240 | | 5. | Etoposide (Toposar) (20 mg/ml) | >240 | | 6. | Fluorouracil (50 mg/ml) | >240 | | 7. | Methotrexate (25 mg/ml) | >240 | | 8. | Mitomycin C (0.5 mg/ml) | >240 | | 9. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | 10. | Thiotepa (10 mg/ml) | 26.9 | | 11. | Vincristine Sulfate (1 mg/ml) | >240 | Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 13.6 and 26.9 minutes, respectively. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a black hand with five fingers inside of a square with rounded corners. The hand is facing forward with the fingers spread apart. The hand appears to be wearing a glove or some type of protective covering. The background of the square is white. 11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508 ## 510 (K) SUMMARY # Shandong Baisheng Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | Manufacturer: | Shandong Baisheng Medical Products Co., Ltd.<br>11 Longshan Road, Wo long Industry Park<br>Linqu, Shandong, China | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: | John Zhao,<br>805 Barrington Ave<br>Ontario, CA 91764 | | Telephone Number: | (909) 980-1678 | | Fax Number: | (909) 980-1758 | | Date Summary Prepared: | November 8, 2016 | | Product Trade Name: | Shandong Baisheng Medical Products Co., Ltd.<br>Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue<br>Color, and Tested for Use with Chemotherapy Drugs | | Device Classification Name: | Patient Examination gloves (21 CFR 880.6250). | | Device Class : | Class 1. | | Product Code : | LZA and LZC. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a black and white icon of a hand wearing a glove. The hand is facing upwards with the fingers spread apart. The glove covers the entire hand and wrist. The icon is enclosed in a square with rounded corners. 11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508 Predicate Devices: K 141623 - Eco Medi Glove SDN BHD. EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs ### New device The subject device in this 510(k) Notification is Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs. The Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC). A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner . In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Reason for 510(k) Submission: Device Description: Intended Use: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a black and white drawing of a hand. The hand is facing upwards with the fingers spread apart. The hand appears to be wearing a glove or some type of protective covering. The image is enclosed in a square border. 11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508 | | Chemotherapy Drug and<br>Concentration | Minimum Breakthrough Detection<br>Time ( Minutes ) | |-----|----------------------------------------|----------------------------------------------------| | 1. | Carmustine (BCNU) (3.3 mg/ml) | 13.6 | | 2. | Cisplastin, (1.0 mg/ml) | >240 | | 3. | Cyclophosphamide (20 mg/ml) | >240 | | 4. | Doxorubicin HCl (2.0 mg/ml) | >240 | | 5. | Etoposide (Toposar) (20 mg/ml) | >240 | | 6. | Fluorouracil (50 mg/ml) | >240 | | 7. | Methotrexate (25 mg/ml) | >240 | | 8. | Mitomycin C (0.5 mg/ml) | >240 | | 9. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | 10. | Thiotepa (10 mg/ml) | 26.9 | | 11. | Vincristine Sulfate (1 mg/ml) | >240 | ## Table 1: Chemotherapy Drug Permeation Time CAUTION: Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 13.6 and 26. 9 minutes, respectively. ## Comparison to Predicate Devices: Shandong Baisheng Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs, are substantially equivalent in safety and effectiveness to the ECO MEDI GLOVE SDN. BHD. Powder-Free Nitrile Patient Examination Gloves with Tested for use with Chemotherapy Drugs. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows: > The standards used for Shandong Baisheng Medical Products Co., Ltd. glove production are based on ASTM-D-6319-05. All testing passed for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5. The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a black and white drawing of a hand. The hand is facing upwards and slightly to the left. The hand is wearing a glove that ends at the wrist. The glove appears to be made of a thick material. 11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508 > Gloves were tested and meet the "Powder-free" claim (contain no more than 2 mg powder per glove). ## Discussion of Clinical Tests Performed: Not Applicable - There is no hypoallergenic claim. Substantial Equivalence: The proposed device is substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical properties and characteristics, design and product features. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a black and white drawing of a hand inside of a square. The hand is facing upwards and has five fingers. The hand appears to be wearing a glove or some type of protective covering. 11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508 # Table 2: Comparison between the device and predicate device | Characteristics | Acceptance Criteria | Shandong Baisheng<br>Medical Products<br>Co., Ltd.<br>Synthetic Nitrile<br>Patient Examination<br>Gloves, Powder<br>Free, Blue Color,<br>and Tested for Use<br>with Chemotherapy<br>Drugs | EMG Blue Nitrile<br>Examination Gloves<br>Powder Free with<br>Tested for Use with<br>Chemotherapy Drugs | |-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K-Number | | K161944 | K141623 | | Product Code | LZA, LZC | LZA, LZC | LZA, LZC | | Intended use | A powder free<br>patient examination<br>glove is a disposable<br>device intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | A patient<br>examination glove is<br>a disposable device<br>intended for medical<br>purposes that is worn<br>upon the examiner's<br>hands or finger to<br>prevent<br>contamination<br>between patient and<br>examiner. | A powder free<br>patient examination<br>glove is a disposable<br>device intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. The<br>device is for over-<br>the-counter use. | | Material used | Nitrile | Nitrile | Nitrile | | Color | Blue | Blue | Blue | | Single use | Single Use | Yes | Yes | | Non Sterile | Non Sterile | Non Sterile | Non Sterile | | Dimensions | Overall Length<br>(mm) Min<br>270mm<br>Width (± 5mm)<br>Size S = 85mm<br>Size M = 95mm<br>Size L = 105mm<br>Size XL = 115mm<br>Thickness at Palm<br>(mm)<br>Min; 0.10mm<br>Thickness at Finger | Meets ASTM<br>D6319-10 | Meets ASTM<br>D6319-10 | | | Tip (mm) Min 0.10<br>mm | | | | Physical<br>properties | Before Ageing<br>Tensile Strength<br>(MPa) = 14min<br>Ultimate Elongation<br>(%) = 500min<br>After Aging at 70°C<br>for<br>168 hrs @ 100°C for<br>22 hrs<br>Tensile Strength<br>(MPa) = 14min<br>Ultimate Elongation<br>(%) = 400min | Meets ASTM<br>D6319-10 | Meets ASTM<br>D6319-10 | | Freedom from<br>pinholes | AQL 2.5<br>Inspection Level G-1 | Meets ASTM<br>D5151-06 | Meets ASTM<br>D5151-06 | | Residual<br>Powder | < 2.0 mg/pc | Meets ASTM<br>D5151-06 | Meets ASTM<br>D5151-06 | | Biological<br>Evaluation on<br>Medical<br>Device -<br>-Primary Skin<br>Irritation<br>Test | | Under the conditions<br>of this study, the test<br>article was a non-<br>irritant. | Under the conditions<br>of this study, the test<br>article was a non-<br>irritant. | | Biological<br>Evaluation on<br>Medical<br>Device -<br>Dermal<br>Sensitization<br>Assay | | Under the conditions<br>of this study, the test<br>article was a non-<br>sensitizer. | Under the conditions<br>of this study, the test<br>article was a non-<br>sensitizer. | | | | | | | | | 1) Carmustine<br>(3.3mg/ml<br>or 3000ppm),<br>Breakthrough : 13.6<br>min. | 1) Carmustine<br>(3.3mg/ml<br>or 3000ppm),<br>Breakthrough : 1.3<br>min. | | | | 2)Cisplastin<br>(1.0mg/ml or<br>10,000ppm) | 2)Cyclophosphamide<br>(20mg/ml or<br>20,000ppm), | | | | Breakthrough time :<br>>240 min. | Breakthrough time :<br>>240 min. | | | | 3)Cyclophosphamide<br>(20mg/ml or<br>20,000ppm), | 3) Cytarabine<br>(100mg/ml or<br>100,000ppm), | | | | Breakthrough time :<br>>240 min. | Breakthrough time :<br>>240 min. | | | | 4) Cytarabine<br>(100mg/ml or<br>100,000ppm), | 4)Doxorubicin<br>Hydrochloride<br>(2.0mg/ml or<br>2000ppm), | | | Standards Practice<br>for Assessment of<br>resistance of<br>Medical Glove to<br>Permeation by<br>Chemotherapy drugs<br>ASTM D6978-<br>05(2013) | Breakthrough time :<br>>240 min. | Breakthrough time:<br>>240 min. | | Resistance<br>against<br>Chemotherapy<br>Drugs | | 5) Doxorubicin<br>Hydrochloride<br>(2.0mg/ml or<br>2000ppm), | 5) Etoposide<br>(20mg/ml or<br>20,000ppm), | | | | Breakthrough time :<br>>240 min. | Breakthrough time :<br>>240 min. | | | | 6) Etoposide<br>(20mg/ml or<br>20,000ppm), | 6) Flourouracil<br>(50mg/ml or<br>50,000), | | | | Breakthrough time :<br>>240 min. | Breakthrough<br>time : >240 min. | | | | 7) Flourouracil<br>(50mg/ml or<br>50,000ppm), | 7) Methotrexate<br>(25mg/ml or<br>25,000ppm), | | | | Breakthrough<br>time : >240 min. | Breakthrough<br>time : ><br>240 min. | | | 8) Methorexate<br>(25mg/ml or<br>25,000ppm),<br>Breakthrough<br>time : ><br>240 min.<br><br>9) Paclitaxel<br>(6mg/ml or<br>6,000ppm),<br>Breakthrough time :<br>>240 min.<br><br>10) Thiotepa<br>(10mg/ml or<br>10,000ppm),<br>Breakthrough time :<br>26.9 min<br><br>11)Vincristine<br>Sulfate (1mg/ml<br>or1000ppm)<br>Breakthrough time :<br>>240 min. | 8) Paclitaxel<br>(6mg/ml or<br>6,000ppm),<br>Breakthrough time :<br>>240 min.<br><br>9) Thiotepa<br>(10mg/ml or<br>10,000ppm),<br>Breakthrough time:<br>63.9 min | | 1 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a black and white drawing of a hand wearing a glove. The glove covers the entire hand and extends up the wrist. The drawing is simple and the hand is facing forward. 11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a black hand wearing a glove. The hand is facing forward with the fingers pointing upwards. The glove appears to be made of a thick material, and it covers the entire hand and wrist. The image is set against a white background and is enclosed in a square with rounded corners. **Shandong Baisheng Medical Products Co., Ltd.** ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a black and white drawing of a left hand. The hand is facing upwards and slightly tilted to the left. The fingers are spread apart, and the palm is visible. The drawing is simple and stylized, with no background or other details. 11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508 ## Conclusion The conclusions drawn from the nonclinical tests demonstrate that Shandong Baisheng Medical Product Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (K161944) is as safe, as effective, and performs as well as the legally marketed predicate device K141623, EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs.