White Nitrile Powder Free Patient Examination Glove, Non Sterile

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June 28, 2021 Onetexx SDN BHD % Michael Van Der Woude U.S. Agent Emergo Global Representation 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746 Re: K210775 Trade/Device Name: White Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 1, 2021 Received: April 5, 2021 Dear Michael Van Der 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. 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) 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). Sincerely, Ryan Ortega, Ph D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K210775 Device Name WHITE NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE 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. Type of Use (Select one or both, as applicable) 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. 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}------------------------------------------------ #### 1.0 Submitter: | Name: | Freddy Low | |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Onetexx Sdn Bhd<br>No: 73-86, Jalan Logam 5, Perindustrian Kamunting 3,<br>Kamunting Raya Industrial Estate, 34600 Kamunting, Perak<br>Darul Ridzuan, Malaysia | | Phone No.: | +60 5 8070 666 | | Fax No.: | +60 5 8070 666 | Date of Summary Prepared: 24th June 2021 #### 2.0 Identification of the subject device: | Trade Name | : White Nitrile Powder Free Patient Examination Glove, Non-<br>Sterile | |-----------------------|------------------------------------------------------------------------| | Common Name | : Patient Examination Gloves | | Classification Name | : Patient Examination Gloves | | Device Classification | : 1 | | Regulation Number | : 21 CFR 880.6250 | | Product Code | : LZA. | #### 3.0 Predicate Device: ### K171615 Xingyu Nitrile Powder Free Patient Examination Gloves, White Color Company: Shandong Xingyu Gloves Co., Ltd #### 4.0 Description of The Device: White Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease 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 synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. {4}------------------------------------------------ ### 6.0 Comparison of the Technological Characteristics of the Device: The White Nitrile Powder Free Patient Examination Glove, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1. {5}------------------------------------------------ ### Table 1 | CHARACTERISTICS | | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS | |-----------------|-----------------------------------------------------------|------------|---------------------------------|------------------|----------------------------------------------| | | | | PREDICATE<br>WHITE | CURRENT<br>WHITE | | | | 510(k) Number | - | K171615 | | | | | Manufacturer(s) | - | Shandong Xingyu Gloves Co., Ltd | Onetexx Sdn Bhd | Same | | | Material | ASTM D6319 | Nitrile | Nitrile | Same | | | Color | - | White | White | Same | | | Physical Properties | ASTM D6319 | | | | | | Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 18-25Mpa<br>560-600% | 32.35Mpa<br>568% | Different but<br>within the ASTM<br>standard | | | After Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 17-21Mpa<br>460-560% | 36.10Mpa<br>551% | Different but<br>within the ASTM<br>standard | | | Thickness:<br>- Finger<br>- Palm | ASTM D6319 | 0.08mm<br>0.08mm | 0.10mm<br>0.07mm | Different but<br>within the ASTM<br>standard | | | Powder Free | ASTM D6124 | Below 2mg of residual powder | 0.24 mg/glove | Different but<br>within the ASTM<br>standard | {6}------------------------------------------------ | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | | | PREDICATE<br>WHITE | CURRENT<br>WHITE | | | Biocompatibility | 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 conditions of this<br>study, the test article was a<br>non-irritant or non-sensitizer.<br><br>SKIN IRRITATION DERMAL and<br>SENSITIZATION STUDIES Meets<br>ISO 10993-10: Third Edition<br>2010-08-01 | 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 this<br>study, the test article was a<br>non-irritant or non-sensitizer.<br><br>SKIN IRRITATION DERMAL and<br>SENSITIZATION STUDIES<br>Meets ISO 10993-10: Third<br>Edition 2010-08-01 | 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) | Not Tested | The test material<br>demonstrated a cytotoxic<br>effect under the condition of<br>this study. Additional test i.e.<br>Acute Systemic Toxicity was<br>tested | Different | | | | DEVICE PERFORMANCE | | | | CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON<br>ANALYSIS | | | | WHITE | WHITE | | | Biocompatibility | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (E) | Not Tested | The test item did not induce<br>any systemic toxicity. | Different | | Watertight (1000ml) | ASTM D5151:2019 | Meets<br>• 21 CFR 800.20<br>• ASTM D6319-10<br>(Reapproved 2015)<br>Tested in accordance with ASTM<br>D5151 (Reapproved 2015) with<br>acceptable results | Gloves passed AQL 1.5 | Similar | | Intended use | - | Powder Free Nitrile Patient<br>Examination Gloves, White<br>Color is a disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hand or finger to prevent<br>contamination between patient<br>and examiner. | A patient examination glove is a<br>disposable device made of<br>synthetic rubber latex intended<br>for medical purposes that is<br>worn on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. | Same | | Size | Medical Glove<br>Guidance Manual -<br>Labeling | Small<br>Medium<br>Large<br>X Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Similar | | Single use | Medical Glove<br>Guidance Manual -<br>Labeling | Single Patient Use | Single Use | Same | {7}------------------------------------------------ {8}------------------------------------------------ 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. ### 7.0 Summary of Non-Clinical Testing The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below. {9}------------------------------------------------ | Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | | |------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|-----------------|-----------------|----------|----------|------| | Physical<br>Properties | ASTM D412<br>(Standard Test<br>Method for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the<br>tensile (tension)<br>properties of glove. | Tensile<br>strength | Min 14.0<br>MPa | Min 14.0<br>MPa | 32.35Mpa | 36.10Mpa | Pass | | | | | Ultimate<br>elongation | Min<br>500% | Min<br>400% | 568% | 551% | Pass | | Test<br>Method | Standard | Purpose<br>of Testing | Acceptance Criteria | | Results (in mm) | | | | Status | | |----------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------|-----------------|------|------|------|--------|------| | | | | | | XS | S | M | L | XL | | | Dimension | ASTM<br>D3767<br>Standard<br>Practice for<br>Rubber-<br>Measureme<br>nt of<br>Dimensions | To measure<br>the length,<br>width and<br>thickness of<br>glove | Length | Min 240 mm | 250 | 250 | 249 | 249 | 250 | Pass | | | | | Width | X-Small - 70 ± 10 mm<br>Small - 80 ± 10 mm<br>Medium - 95 ± 10 mm<br>Large - 110 ± 10 mm<br>X-Large – 120 ± 10 mm | 78 | 87 | 98 | 107 | 118 | Pass | | | | | Thickness | Finger - min 0.05mm | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | Pass | | | | | | Palm - min 0.05mm | 0.06 | 0.06 | 0.07 | 0.07 | 0.07 | | {10}------------------------------------------------ | 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: 500 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<br>:0.24mg/glove | Pass | {11}------------------------------------------------ ### 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 White 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 Xingyu Nitrile Powder Free Patient Examination Gloves, White Color (K171615).