White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 12, 2018 Riverstone Resources SDN BHD Suresh Kumar QA Manager Lot 56, No 15, Jalan Jasmin 2 Bukit Beruntung, Selangor 48300 Malaysia Re: K180452 Trade/Device Name: White Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: May 3, 2018 Received: May 11, 2018 Dear Suresh Kumar: 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 {1}------------------------------------------------ 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 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Geeta K. Pamidimukkala -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) K180452 Device Name White Nitrile Examination Gloves Sterile Tested For Used With Chemotherapy Drugs Claim Indications for Use (Describe) The White Nitrile Examination Glove,Sterile, is a disposable device intended for medical purposes that is worn on the examiner Is hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs | Chemotherapy Drugs and Concentration | Minimum Breakthrough detection time in minutes, 0.01 $\mu$ g/cm2/minute | |---------------------------------------|-------------------------------------------------------------------------| | Carmustine (BCNU)(3.3 mg/ml) | 17.1 Minutes | | Cyclophosphamide (20 mg/ml) | > 240 Minutes | | Cisplatin (1.0 mg/ml) | > 240 Minutes | | Dacarbazine (DTIC) (10 mg/ml) | > 240 Minutes | | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 Minutes | | Etoposide (20 mg/ml) | > 240 Minutes | | Fluorouracil (50 mg/ml) | > 240 Minutes | | Paclitaxel (6.0 mg/ml) | > 240 Minutes | | Thiotepa (IO mg/ml) | 55.9 minutes | The Maximum testing time is 240 Minutes. Please note that the following drugs have extremely low permeartion time: Carmustine (BCNU)(3.3mg/ml) Thiotepa ( 10mg/ml) | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor #### 510K No : K180452 #### 510(K) Summary White Nitrile Examination Glove,Sterile Tested for use with Chemotherapy Drugs claim #### 1.0 Submitter : | Company Name | : RIVERSTONE RESOURCES SDN BHD | |-----------------|-----------------------------------------------------------------------------------------------------------------------| | Company Address | : Lot 55, No 13, Jalan Jasmin 2,<br>Kawasan Perindustrian Bukit Beruntung<br>48300, Bukit Beruntung Selangor Malaysia | | Contact Person | : | Mr Suresh Kumar | |----------------|---|-----------------------| | Telephone No | : | 603-60283033 | | Email | : | qa1@riverstone.com.my | ### 2.0 Preparation Date : 12th June 2018 #### 3.0 Name of the Device Trade Name / Proprietary Name : White Nitrile Examination Glove, Sterile tested for use with Chemotherapy Drugs claims. Device Name : Nitrile Patient Examination gloves. Device Classification Name : Patient Examination gloves (21 CFR 880.6250). Device Class : Class I. Product Code : Nitrile-LZA and LZC. {4}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor #### 510K No : K180452 #### 4.0 Identification of The Legally Marketed Device : The Primary Predicate K161187, EMG Blue Nitrile Examination Gloves Powder Free With Tested for use with Chemotherapy Drugs, and K171093 Sterile Nitrile Patient Examination Gloves, Powder Free. #### 5.0 Device Description The subject device in this 510(k) Notification is White Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, White color, powder free and sterile (Per 21 CFR 880.6250, class I). The White Nitrile Examination Glove ,Sterile, 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). #### Indication for Use: The White Nitrile Examination Glove, Sterile, 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 and for use with chemotherapy drugs . In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs. | Chemotherapy Drug and concentration | Minimum Breakthrough detection<br>time in Minutes,µg/cm²/minute | |---------------------------------------|-----------------------------------------------------------------| | 1)Carmustine (BCNU) (3.3mg/ml) | 17.1 minutes | | 2)Cyclophosphamide(20mg/ml) | > 240 minutes | | 3)Cytarabine (10mg/ml) | > 240 minutes | | 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes | | 5)Etoposide (20mg/ml) | > 240 minutes | | 6)Fluorouracil (50mg/ml) | > 240 minutes | | 7)Methotrexate (25mg/ml) | > 240 minutes | | 8) Paclitaxel (6mg/ml) | > 240 minutes | | 9) Thiotepa (10mg/ml) | 55.9 minutes | The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time. Carmustine (BCNU) (3.3mg/ml) - Minimum Breakthrough detection time 17.1 ug/cm2/minute. Thiotepa (10mg/ml) - Minimum Breakthrough detection time 55.9 ug/cm²/minute. {5}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor #### 510K No : K180452 ### 6.0 Specification for Nitrile gloves: 6.1 Dimension and Thickness of Gloves | Dimension | Size S | Size M | Size L | Size XL | |------------------------------------------|--------|--------|--------|---------| | Overall Length (mm) (Minimum) | 230 | 230 | 230 | 230 | | Width (± 5mm) | 85 | 95 | 105 | 115 | | Thickness at Palm (mm)<br>(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 | | Thickness at Finger Tip<br>(mm)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 | | Measurement | Before Ageing | After Aging at 70°C for 168 hrs @ 100°C for 22 hrs | |-------------------------|------------------------------|----------------------------------------------------| | Tensile Strength (MPa) | 14min | 14 Min | | Ultimate Elongation (%) | 500min | 400min | | Pin-hole Level | AQL 2.5 Inspection Level G-1 | AQL 2.5 Inspection Level G-1 | #### 6.1.2 Gloves Physical Properties and Holes Pin-hole Level Gloves meet all the specification listed in ASTM D 6319-10 ### 7.0 Summary of the Technological Characteristics of the Device There are no differences in technological characteristics of the subject device compare with the predicate device. The gloves are made from nitrile latex compound, White color, Sterile. The gloves met all the specifications in ASTM D6319-10 Standard specification for Nitrile Examination Gloves as well Biological Evaluation on medical device. Additionally, the gloves have been tested for permeability to chemotherapy drugs. {6}------------------------------------------------ 510K No : K180452 Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor Acceptance Characteristics White Nitrile Sterile Nitrile EMG Blue Nitrile Assessment Examination Patient Examination Criteria Similarities Examination Glove, Sterile Gloves, Powder and tested for use with Gloves. Free with tested for Differences Powder use with chemotherapy drugs Free,K171093 chemotherapv claim.K180452 drugs, K161187 (Primary Predicate) LZA and LZA and LZC LZA LZA and LZC Subject is same LZC with 510k:161187 Subject is different with 510k :171093 Intended use A powder A powder free A powder free A powder free Same patient examination patient examination patient free patient glove is a disposable glove is a disposable examination glove examination device intended for device intended for is a disposable glove is a medical purposes medical purposes device intended for disposable that is worn on the that is worn on the medical purposes device examiner's hand or examiner's hand or that is worn on the intended for finger to prevent finger to prevent examiner's hand medical contamination contamination or finger to prevent purposes between patient and between patient and contamination that is worn examiner. examiner. between patient on the and examiner. examiner's hand or finger to prevent contaminati on between patient and examiner. The device is for The device The device is for The device is for over-the-counter over-the-counter over-the-counter is for overuse. use. use. the-counter use. Sterile Examination Sterile Examination Non Sterile Different Description glove glove Examination {7}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor | | | 510K No : K180452 | | | | Physical properties | | | | | | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------| | | | made of Nitrile and<br>color White and<br>tested with<br>chemotherapy Drugs | made of Nitrile and<br>color Blue | glove made of<br>Nitrile and color<br>Blue and tested<br>with<br>chemotherapy<br>Drugs | | | Before Aging | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same | | Presentation | | Sterile glove are<br>provided in<br>Pouches | Sterile glove are<br>provided in<br>Pouches | Non Sterile is<br>provided in<br>dispenser | Different | Tensile Strength (MPa) = 14min<br>Ultimate Elongation (%) = 500min<br>After Aging at 70°C for 168 hrs @<br>100°C for 22 hrs | Tensile Strength (MPa) = 14min | | | | | | Ambidextrous | | Yes | Yes | Yes | Same. | | Ultimate Elongation (%) = 400min | | | | | | Material use | Nitrile<br>Synthetic<br>Latex | Nitrile Synthetic<br>Latex | Nitrile Synthetic<br>Latex | Nitrile Synthetic<br>Latex | Similar | | Freedom from pinholes | AQL 2.5 Inspection Level G-1 ASTM D6319-10 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | | Colour | | White | Blue | Blue | Different | | Residual Powder | <2.0 mg/pc ASTM D6124-06 | Meets ASTM D6124-06 | Meets ASTM D6124-06 | Meets ASTM D6124-06 | | Sterility | Sterility | Sterile<br>Gamma Irradiation<br>ISO 11137-2:2015 | Sterile<br>EO sterilization<br>ISO 11135:2014 | Non-sterile | Different<br>The difference in<br>sterilization process<br>did not raise new<br>questions of safety<br>and effectiveness | | Biological Evaluation on Medical Device - Primary Skin Irritation Test | Non irritant- Primary Skin Irritation in Rabbit<br>ISO 10993-10 | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. | | Single used | | Single used | Single used | Single used | | | Biological Evaluation on Medical Device- Dermal Sensitization Assay | Non - sensitizer- Skin sensitization in Giunea | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. | | Dimensions | Overall<br>Length<br>(mm)<br>Min 230<br>mm<br>Width (±<br>5mm)<br>Size S<br>=<br>85mm<br>Size M<br>=<br>95mm<br>Size L<br>=<br>105mm<br>Size XL =<br>115mm<br>Thickness<br>at Palm<br>(mm)<br>Min; 0.05<br>mm<br>Thickness<br>at Finger<br>Tip (mm)<br>Min 0.05<br>mm | Meets ASTM<br>D6319-10 | Meets ASTM<br>D6319-10 | Meets ASTM<br>D6319-10 | Same | | | | | | | {8}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor ## 510K No : K180452 {9}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor | | ISO 10993-<br>10 | | | | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Resistance<br>against<br>Chemotherapy<br>Drugs | Standards<br>Practice for<br>Assessment<br>of<br>resistance<br>of Medical<br>Glove to<br>Permeation<br>by<br>Chemothera<br>py drugs<br>ASTM<br>D6978-<br>05(2013) | 1) Carmustine<br>(3.3mg/ml or<br>3000ppm),<br>Minimum<br>Breakthrough<br>detection time :<br>17.1<br>µg/cm²/minute<br><br>2)<br>Cyclophosphamide<br>(20mg/ml or<br>20,000ppm),<br>Minimum<br>Breakthrough<br>detection time:<br>>240<br>µg/cm²/minute<br><br>3) Cisplatin<br>(1.0mg/ml or<br>1,000ppm),<br>Minimum<br>Breakthrough<br>detection time:<br>>240<br>µg/cm²/minute<br><br>4)Doxorubicin<br>Hydrochloride<br>(2.0mg/ml or<br>2000ppm),<br>Minimum<br>Breakthrough<br>detection time:<br>>240<br>µg/cm²/minute<br><br>5) Etoposide<br>(20mg/ml or<br>20,000ppm),<br>Minimum<br>Breakthrough<br>detection time: | 1) Carmustine<br>(3.3mg/ml or<br>3000ppm),<br>Minimum<br>Breakthrough<br>detection time:<br>1.3<br>µg/cm²/minute<br><br>2)<br>Cyclophosphamid<br>e (20mg/ml or<br>20,000ppm),<br>Minimum<br>Breakthrough<br>detection time:<br>>240<br>µg/cm²/minute<br><br>3) Cytarabine<br>(100mg/ml),<br>Minimum<br>Breakthrough<br>detection time:<br>>240<br>µg/cm²/minute<br><br>4)Doxorubicin<br>Hydrochloride<br>(2.0mg/ml or<br>2000ppm),<br>Minimum<br>Breakthrough<br>detection time:<br>>240<br>µg/cm²/minute<br><br>5) Etoposide<br>(20mg/ml or<br>20,000ppm),<br>Minimum<br>Breakthrough<br>detection time:<br>>240<br>µg/cm²/minute | Different | {10}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor 510K No : K180452 >240 μg/cm²/minute 6) Flourouracil (50mg/ml or 6) Flourouracil 50,000), (50mg/ml or Minimum Breakthrough 50,000), Minimum Breakthrough detection time: detection time: >240 >240 μg/cm²/minute μg/cm²/minute 7) Methorexate (25mg/ml or 25.000ppm). 7) Paclitaxel Minimum (6mg/ml or Breakthrough 6,000ppm), detection time: > Minimum Breakthrough 240 detection time: ug/cm²/minute >240 μg/cm²/minute 8) Paclitaxel (6mg/ml or6,000ppm), 8) Thiotepa (10mg/ml or Minimum Breakthrough 10,000ppm), detection time: Minimum >240 Breakthrough ug/cm²/minute detection time: ર્સ વ μg/cm²/minute 9) Thiotepa (10mg/ml or 10,000ppm), Minimum Breakthrough detection time: 67.8 μg/cm²/minute 9) Dacarbazine (1.0 mg/ml ), Minimum Breakthrough detection time: >240 ug/cm²/minute {11}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor #### 510K No : K180452 #### 8.0 Summary of Non-Clinical Testing The gloves are made from nitrile latex compound, White colour,Sterile. The gloves met all the specifications in ASTM D6319-10 Standard specification for Nitrile Examination Gloves as well Biological Evaluation on medical device. Additionally, the gloves have been tested for permeability to chemotherapy drugs. #### 9.0 Conclusion Based on intended uses, technological characteristics and non - clinical performance data, the White Nitrile Examination Gloves, Sterile with tested for use with Chemotherapy Drugs is as safe, as effective, and performs as well as the legally marketed predicate device, K 171093 ,Sterile Nitrile Patient Examination Gloves, Powder Free and K 161187, EMG Blue Nitrile Examination Gloves Powder Free With Tested for Use with Chemotherapy Drugs.