Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs

{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. February 8, 2022 Rimba Glove SDN BHD % Michael Woude U.S Agent Emergo Global Representation LLC 2500 Bee Cave Road Bldg 1, Suite 300 Austin, Texas 78746 Re: K212898 Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dear Michael Woude: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 16, 2021. Specifically, FDA is updating this SE Letter to address a typo in the sponsor name as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Clarance Murray, OHT4: Office of Surgical and Infection Control Devices, 301-796-0870, Clarence.Murray@fda.hhs.gov. Image /page/0/Picture/8 description: The image shows the text "Sincerely," followed by the name "Liqun Zhao -S". The text is written in a clear, legible font and is likely part of a signature or closing statement. The name is slightly larger than the word "Sincerely,". The image appears to be a cropped portion of a larger document. For Clarence W. Murray, III, Ph.D Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 16, 2021 Rimba Glove SND BHD % Michael Woude U.S Agent Emergo Global Representation LLC 2500 Bee Cave Road Bldg 1. Suite 300 Austin, Texas 78746 Re: K212898 Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 4, 2021 Received: September 10, 2021 Dear Michael Woude: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {2}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerelv. # Liqun Zhao -S For Clarance W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K212898 ### Device Name BLUE NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE, 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 on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug | Breakthrough Detection Time in Minutes | |----------------------------|----------------------------------------| | *Carmustine (BCNU) | 23.0 | | Cisplatin | > 240 | | Cyclophosphamide (Cytoxan) | > 240 | | Dacarbazine | > 240 | | Doxorubicin HCI | > 240 | | Etoposide | > 240 | | Fluorouracil | > 240 | | Ifosfamide | > 240 | | Methotrexate | > 240 | | Mitomycin C | > 240 | | Mitoxantrone | > 240 | | Paclitaxel | > 240 | | *Thiotepa | 98.8 | | Vincristine Sulfate | > 240 | *CAUTION: Testing showed an average breakthrough time of 23.0 minutes for Carmustine and an average breakthrough time of 98.9 minutes for Thiotepa. ### ** WARNING: DO NOT USE WITH CARMUSTINE. Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ 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." {5}------------------------------------------------ #### 1.0 Submitter: | Name: | Zahari Bin Darus | |------------|------------------------------------------------------------------------------------------------------| | Address: | Rimba Glove Sdn Bhd<br>Plot 37, Medan Tasek, Tasek Industrial Estate, 31400 Ipoh,<br>Perak, Malaysia | | Phone No.: | +605-5483688 | | Fax No.: | +605-5481688 | Date of Summary Prepared: 20th August 2021 (REVISED DATE: 7th Dec 2021) #### Identification of the subject device: 2.0 | Trade Name | : Blue Nitrile Powder Free Patient Examination Glove, Non-<br>Sterile, Tested for use with Chemotherapy Drugs. | |-----------------------|----------------------------------------------------------------------------------------------------------------| | Common Name | : Patient Examination Gloves | | Classification Name | : Patient Examination Gloves | | Device Classification | : 1 | | Regulation Number | : 21 CFR 880.6250 | | Product Code | : LZA, LZC | #### 3.0 Predicate Device: ### K210944 Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue). Company: Harbour Health LLC. #### 4.0 Description of The Device: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Tested for use with Chemotherapy Drugs meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves underqoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. #### 5.0 Indication for use: A patient examination qlove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device has also been tested for use with Chemotherapy Drugs per ASTM D 6978-5(2019). WARNING: DO NOT USE WITH CARMUSTINE. #### 6.0 Comparison of the Technological Characteristics of the Device: The Blue Nitrile Powder Free Patient Examination Glove. Non-Sterile tested for use with chemotherapy drugs are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1. {6}------------------------------------------------ Table 1 | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | |-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | | | PREDICATE<br>BLUE | CURRENT<br>BLUE | | | 510(k) Number | - | K210944 | K212898 | | | Manufacturer(s) | - | Harbour Health LLC, New Jersey<br>07059. | Rimba Glove Sdn Bhd | | | Material | ASTM D6319 | Nitrile | Nitrile | Same | | Color | - | Blue | Blue | Same | | Texture | - | Finger texture | Finger Texture | Same | | Physical Properties | ASTM D6319 | | | | | Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | | ≥ 14Mpa<br>500% | 31.2Mpa<br>594% | Different but<br>within the ASTM<br>standard | | After Aging<br>Tensile Strength:<br>Ultimate Elongation: | | ≥ 14Mpa<br>400% | 34.7Mpa<br>553% | Different but<br>within the ASTM<br>standard | | Thickness:<br>- Finger<br>- Palm | ASTM D6319 | 0.05mm<br>0.05mm | 0.10mm<br>0.07mm | Different but<br>within the ASTM<br>standard | | Powder Free | ASTM D6124 | ≤ 2 mg/glove | 0.26 mg/glove | Different but<br>within the ASTM<br>standard | | | | DEVICE PERFORMANCE | | | | CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON<br>ANALYSIS | | | | BLUE | BLUE | | | | Primary Skin Irritation<br>- ISO 10993-10:2010<br>(E) & Consumer<br>Product Safety<br>Commission Title 16.<br>Chapter II, Part 1500 | Under the condition of study,<br>the device is a non-irritant | Under the conditions of study,<br>the test material did not cause<br>an irritant response. The<br>Primary Irritant Response<br>Category is deemed 'Negligible' | Similar | | | Dermal Sensitization-<br>ISO 10993-10: 2010<br>(E) & Consumer<br>Product Safety<br>Commission, Title 16,<br>Chapter II, Part<br>1500.3 (c) (4) | Under the conditions of the<br>study, the device is a non-<br>sensitizer | Under the conditions of study,<br>the test material did not<br>produce a skin sensitization<br>effect in the guinea pigs. | Similar | | Biocompatibility | Cytotoxicity - MEM<br>Elution, ISO 10993-5:<br>2009 (E) | Under the conditions of the<br>study, the device is potentially<br>cytotoxic. | Under the conditions of study,<br>the test material demonstrated<br>a cytotoxic effect under the<br>condition of this study.<br>Additional test i.e. Acute<br>Systemic Toxicity was tested. | Similar | | | | DEVICE PERFORMANCE | | | | CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON<br>ANALYSIS | | | | BLUE | BLUE | | | Biocompatibility | Acute Systemic<br>Toxicity,<br>ISO 10993-<br>11:2017 (Ε) | Under the conditions of study, the<br>device does not elicit a systemic<br>toxicity response in the model<br>animal. | Under the conditions of study,<br>the test item did not induce<br>any systemic toxicity in Swiss<br>albino mice. | Similar | | Watertight (1000ml) | ASTM D 6319-<br>19<br>ASTM D5151-19 | Complies with ASTM D6319-19 and<br>ASTM D5151-19, G-1, AQL 2.5 | Gloves passed AQL 1.5 | Different but well<br>within the ASTM<br>D6319-19 | | Intended use | - | The Harbour Health Powder Free<br>Nitrile Examination Glove, Blue<br>(Tested for use with Chemotherapy<br>Drugs) is a disposable device<br>intended for medical purposes that is<br>worn on the examiner's hand to<br>prevent contamination between<br>patient and examiner. The proposed<br>device was tested for use with<br>Chemotherapy drugs per ASTM<br>D6978-05(2019), Standard Practice<br>for Assessment of Medical Gloves to<br>Permeation by Chemotherapy drugs. | A patient examination glove is<br>a disposable device made of<br>nitrile rubber intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner.<br>The device has also been<br>tested for use with<br>Chemotherapy Drugs per ASTM<br>D 6978-5(2019) | Same | | Size | Medical Glove<br>Guidance<br>Manual -<br>Labeling | Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Similar | | Single use | Medical Glove<br>Guidance<br>Manual -<br>Labeling | Single Use | Single Use | Same | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | | | | PREDICATE | CURRENT | | | | | BLUE | BLUE | | | Chemotherapy Drugs<br>Permeation Test | | Minimum Breakthrough<br>Detection Times in Minutes | Minimum Breakthrough<br>Detection Times in Minutes | | | Carmustine (BCNU) -<br>3.3 mg/ml | | 14.5 | 23.0 | Different in the<br>result | | Cisplatin - 1.0 mg/ml | | >240 | >240 | Same | | Cyclophosphamide (Cytoxan)<br>- 20.0 mg/ml | | >240 | >240 | Same | | Dacarbazine – 10.0 mg/ml | | >240 | >240 | Same | | Doxorubicin HCI – 2.0 mg/ml | | >240 | >240 | Same | | Etoposide - 20.0 mg/ml | | >240 | >240 | Same | | Fluorouracil – 50.0 mg/ml | ASTM D6879-<br>5(2019) | >240 | >240 | Same | | Ifosfamide – 50.0 mg/ml | | >240 | >240 | Same | | Methotrexate - 25 mg/ml | | >240 | >240 | Same | | Mitomycin C - 0.5 mg/ml | | >240 | >240 | Same | | Mitoxantrone – 2 mg/ml | | >240 | >240 | Same | | Paclitaxel - 6.0 mg/ml | | >240 | >240 | Same | | Thiotepa – 10 mg/ml | | 47.4 | 98.8 | Different in the<br>result | | Vincristine Sulfate - 1 mg/ml | | >240 | >240 | Same | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ There are no significant differences between the two products and they are the same or similar in terms of intended use, materials design, physical properties, thickness and biocompatibility test. #### Summary of Non-Clinical Testing 7.0 The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below. {11}------------------------------------------------ | Test Method | Standard | Purpose of Testing | | Acceptance Criteria | | Results | | Status | |---------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------|---------------------|--------------|--------------|-------------|--------| | | | | | Before aging | After aging | Before aging | After aging | | | Physical Properties | ASTM D412<br>(Standard Test Method for<br>Vulcanized Rubber and Thermoplastic<br>Elastomers-Tension) | To evaluate the tensile (tension) properties of glove. | Tensile strength | Min 14.0 MPa | Min 14.0 MPa | 31.2Mpa | 34.7Mpa | Pass | | | | | Ultimate elongation | Min 500% | Min 400% | 594% | 553% | Pass | {12}------------------------------------------------ | Test<br>Method | Standard | Purpose of<br>Testing | Glove<br>Size | Acceptance Criteria | | | Results | | | Status | |----------------|----------------------------------------------------------------------------|--------------------------------------------------------------|---------------|---------------------|-----------------|------------|-----------|---------|----|--------| | Dimension | ASTM D3767<br>Standard Practice for<br>Rubber—Measurement<br>of Dimensions | To measure the<br>length, width<br>and thickness<br>of glove | X-Small | Length | Min 240 mm | | Length | 250 mm | | Pass | | | | | | Width | $70 \pm 10$ mm | | Width | 78.0 mm | | Pass | | | | | | Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass | | | | | | | Palm | min 0.05mm | | 0.07 mm | | | | | | | Small | Length | Min 240 mm | | Length | 250 mm | | Pass | | | | | | Width | $80 \pm 10$ mm | | Width | 88.0 mm | | Pass | | | | | | Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass | | | | | | | Palm | min 0.05mm | | 0.07 mm | | | | | | | Medium | Length | Min 240 mm | | Length | 250 mm | | Pass | | | | | | Width | $95 \pm 10$ mm | | Width | 98.0 mm | | Pass | | | | | | Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass | | | | | | | Palm | min 0.05mm | | 0.07 mm | | | | | | | Large | Length | Min 240 mm | | Length | 250 mm | | Pass | | | | | | Width | $110 \pm 10$ mm | | Width | 108 mm | | Pass | {13}------------------------------------------------ | | | | Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | | Pass | |--|---------|--|-----------|---------------------|-----------|---------|--|------| | | | | | Palm – min 0.05mm | | 0.07 mm | | | | | X-Large | | Length | Min 240 mm | Length | 250 mm | | Pass | | | | | Width | $120 \pm 10$ mm | Width | 118 mm | | Pass | | | | | Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | | Pass | | | | | | Palm – min 0.05mm | | 0.07 mm | | | {14}------------------------------------------------ | Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status | |----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Watertight | ASTM D5151<br>(Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves) | To detect holes<br>that leak water<br>and thereby<br>compromise the<br>usefulness of the<br>glove. | Sample size: 315 pcs<br>Inspection level: G1<br>AQL: 1.5, Acceptance No. 10 | The batch size for this<br>sampling is 150,001 to<br>500,000. Hence,<br>according to the single<br>sampling plan GI, the<br>sample to be drawn is<br>under code M<br>equivalent to 315<br>pieces with accept 10<br>and reject 11 to be<br>accepted under AQL<br>1.5. During the test, 1<br>piece was found with<br>leaks. Hence it falls<br>within the acceptance<br>criteria. | Pass | | Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status | |--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------|--------| | Residual<br>Powder | ASTM D6124<br>(Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves) | To determine the<br>amount of<br>residual powder<br>and non-powder<br>solids found on<br>gloves. | Less than 2 mg per glove | Sample size : 5 pcs<br>Requirement : <2mg/glove<br>Result :0.26mg/glove | Pass | {15}------------------------------------------------ #### 8.0 Summary of Clinical Testing: No clinical study is included in this submission. #### 9.0 Conclusion The conclusion drawn from the non-clinical tests demonstrate that the subject Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K210944.