Disposable Nitrile Examination Gloves

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September 21, 2021 Foshan Kangkang Biotechnology Co., LTD Yico Xie General Manager 2nd Floor, Building 4, Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District Foshan City, Guangdong 528225 China Re: K211073 Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 4, 2021 Received: August 4, 2021 Dear Yico Xie: 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 mediation-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, For Clarence W. Murray, III, PhD 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K211073 Device Name Disposable Nitrile Examination Gloves Indications for Use (Describe) Disposable Nitrile Examination Gloves is a non-sterile 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) × 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}------------------------------------------------ # 510(k) Summary ### K211073 Date of Summary Preparation: March 31, 2021 Date of Modification: July 23, 2021 ### 1. Submitter's Identifications Submitter's Name: FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD Address: 2nd Floor,Building 4,Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District, Foshan City, Guangdong Province, China Contact Person: Yico Xie Contact Title: General Manager Contact E-mail Address: kangkang biotechnology(@aliyun.com Zip code: 528225 Telephone: +86-13702554142 #### 2. Correspondent's Identifications Correspondent's Name: FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD Address: 2nd Floor, Building 4, Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District, Foshan City, Guangdong Province, China ZIP Code: 528225 Contact Person: Yico Xie Contact Title: General Manager Contact E-mail Address: Kangkangfda@126.com Telephone: +86-13702554142 #### 3. Name of the Device Device Classification Name: Non-powdered Patient examination glove Common Name: Polymer Patient Examination Glove Trade Name: Disposable Nitrile Examination Gloves Model/Size: S, M, L, XL Classification Panel: General Hospital Product Code: LZA Device Classification: Class I #### 4. The Predicate Devices Powder Free Nitrile Patient Examination Gloves, Blue Color K181106 #### 5. Device Description The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile. #### 6. Indications for Use Disposable Nitrile Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. {4}------------------------------------------------ # 7. Summary of Technological Characteristics | | Proposed Device | | Primary predicate device | Comparison | | |-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------| | 510k Number | K211073 | | K181106 | | | | Manufacturer | FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD | | JiangSu DongXin Medical Technology Co., Ltd | | | | Proprietary<br>Name | Disposable Nitrile Examination Gloves | | Powder Free Nitrile Patient Examination Gloves, Blue Color | | | | Regulation<br>Number | 21 CFR 880.6250 | | 21 CFR 880.6250 | Same | | | Product Code | LZA | | LZA | Same | | | Color | Blue | | Blue | Same | | | Size | S, M, L, XL | | S, M, L, XL | Same | | | Indications for<br>Use | Disposable Nitrile Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | | Powder Free Nitrile Patient Examination Gloves, Blue Color 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. | Same | | | Device<br>Description and<br>Specifications | Meets ASTM D6319-19 | | Meets ASTM D6319-10 | Same | | | Freedom from<br>Pinholes<br>IL I AQL2.5 | 1) Inspection 125pcs, Inspection Level I AQL2.5, and Accept/Reject criteria of 7/8<br>2) Water leakage test: 0 noncompliance. | | 1) Inspection Level I AQL2.5, and Accept/Reject criteria of 10/11<br>2) Water leakage test: 5 noncompliance is allowed. | Similar | | | Dimensions<br>-Length<br>ILS-2 AQL4.0 | Meets ASTM D6319-19<br>230mm min. for all sizes | | 232 mm min for all sizes | Similar | | | Dimensions<br>-Width<br>IL S-2 AQL4.0 | Meets ASTM D6319-19<br>S 82-85mm<br>M 93-97mm<br>L 100-103mm<br>XL 110-111mm | | S 76-90mm<br>M 89-102mm<br>L 108-119mm<br>XL 115-128mm | Similar | | | Dimensions<br>-Thickness<br>IL S-2 AQL4.0 | Meets ASTM D6319-19<br>Thickness (mm) min.<br>Finger: 0.13 | | Thickness (mm) min.<br>Finger: 0.08<br>Palm: 0.08 | Similar | | | | Palm: 0.07 | | | | | | Physical<br>Properties<br>IL S-2 AQL4.0 | Before Aging | After Aging | Before Aging | After Aging | Similar | | Tensile Strength<br>(MPa) | 15.3-23.4 | 14.1-30.6 | 18-25 | 17-22 | Similar | | Ultimate<br>Elongation (%) | 500.972-<br>595.086 | 416.106-<br>601.187 | 550-600 | 450-570 | | | Residual Powder | 1) Checked on 5pcs<br>sub-samples (N=5).<br>2) Result as following: Mean:<br>0.18mg/glove | | 2) Checked on 5pcs<br>sub-samples (N=5).<br>2) Result as following: Mean:<br>0.1mg/pcs | | Similar | | Materials | Nitrile | | Nitrile | | Same | | Single Patient<br>Use | Single Patient Use | | Single Patient Use | | Same | | Biocompatibility | Under the conditions of this<br>study, the test article was a<br>non irritant or non sensitizer | | Under the conditions of this<br>study, the test article was a<br>non irritant or non sensitizer | | Same | | | Under the conditions of this<br>study, the test article was<br>slight cytotoxic to L-929 cells<br>and was accepted in the agar<br>diffusion method. | | Under the conditions of this<br>study, the test article was non<br>cytotoxicity to L-929 cells. | | Similar | | | Under the conditions of this<br>study, the test article was<br>showed no evidence of causing | | Not publicly available | | Different7 | | Labeling for the<br>legally marketed<br>device to which<br>substantial<br>equivalence is<br>claimed | -Powder Free<br>-Patient Examination Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Blue color<br>- Non sterile | | -Powder Free<br>-Patient Examination Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Blue color<br>- Non sterile | | Same | | Standard | ASTM D6319-19<br>ASTM D6124-06<br>(Reapproved 2017)<br>ASTM D5151-19<br>ISO 10993-5:2009<br>ISO 10993-10:2010<br>ISO 10993-11:2017 | | ASTM<br>D6319-10(Reapproved 2015)<br>ASTM D6124-06<br>(Reapproved 2017)<br>ASTM<br>D5151-06(Reapproved2015)<br>ISO 10993-5:2009<br>ISO 10993-10:2010 | | Similar8 | ### Table 1 Comparison to Predicate Device {5}------------------------------------------------ # 8. Summary of Non-Clinical Testing: Non-clinical tests were conducted to verify that the proposed device met acceptance criteria {6}------------------------------------------------ for each test. ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization ISO10993-11:2017 Biological evaluation of medical devices - Part11: Tests for systemic toxicity, implemented test for acute system toxicity ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves Summary of the non-clinical testing is shown as below: {7}------------------------------------------------ # FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD | Test Methodology | Purpose | Acceptance Criteria | Results | |------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | In Vitro Cytotoxicity Test:<br>Agar diffusion Method | The purpose of the test is to<br>determine the potential cytotoxicity<br>toxicity of a mammalian cell culture<br>(mouse fibroblast L-929 cells) in<br>response to the test article. | The test sample met the requirements of the test if the biological<br>response was less than or equal to grade 2. | Under the conditions of<br>this study, the test article<br>was Slight cytotoxic and<br>was accepted in the agar<br>diffusion method. | | Skin Sensitization Test:<br>Guinea Pig Maximization | The test was designed to evaluate<br>the potential of a test article to cause<br>skin sensitization. The test is used as<br>a procedure for screening of contact<br>allergens in guinea pigs and<br>extrapolating the results to humans,<br>but it does not establish the actual<br>risk of sensitization. | Magnusson and Kligman grades of 1 or greater in the test group<br>generally indicate sensitization, provided grades of less than 1<br>are seen in control animals.<br>If grades of 1 or greater are noted in control animals, then the<br>reactions of test animals which exceed the most severe reaction<br>in control animals are presumed to be due to sensitization.<br>If the response is equivocal, rechallenge is recommended to<br>confirm the results from the first challenge.<br>The outcome of the test is presented as the frequency of positive<br>challenge results in test and control animals. | The test article showed no<br>evidence<br>of<br>causing<br>delayed dermal<br>contact<br>sensitization in the guinea<br>pig. | | Skin Irritation Test:<br>Extraction Method | To evaluate the potential<br>skin<br>irritation caused by test article<br>contact with the skin surface of<br>rabbits and extrapolating the results<br>to humans, but it does not establish<br>the actual risk of irritation. | When blank or negative control was used, calculate the primary<br>irritation score for the controls and subtract that score from the<br>score using the test material to obtain the primary irritation<br>score. | The test result showed that<br>the response of the test<br>article<br>extract<br>was<br>categorized as negligible<br>under the test condition. | | Acute Systemic Toxicity Test:<br>Extraction Method | The test was designed to evaluate<br>the potential acute system toxicity<br>caused by test article contact with<br>the ICR mice and extrapolating the<br>results to humans. | Within the monitoring period (72 h), if the toxicosis response<br>of testing group is not greater than that of control group, the<br>testing sample is regarded as acceptable. In case that two or<br>more mice show the medium toxicosis symptom or die, the<br>testing sample is regarded as unacceptable. If any animals<br>treated with the sample show only slight signs of biological<br>reactivity, and not more than one animal shows gross symptoms<br>of biological reactivity or dies, repeat the testing using groups<br>of 10 animals. On the repeat test, if all 10 animals treated with<br>the sample show no scientifically meaningful biological<br>reactivity above the vehicle control animals during the<br>observation period, the sample meets the requirements of this<br>test. | The test article showed no<br>evidence of causing acute<br>system toxicity in the ICR<br>mice. | {8}------------------------------------------------ | Watertightness Test for<br>Detection of Holes:<br>Sampling procedures for<br>inspection by attributes Part 1:<br>Sampling schemes indexed by<br>acceptance quality limit (AQL)<br>for lot-by-lot inspection (ISO<br>2859-1:1999)<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application (ASTM<br>D6319 - 19)<br>Standard Test Method for<br>Detection of Holes in Medical<br>Gloves (ASTM D 5151-19) | The test was designed to validate the<br>properties of the test glove.<br>Water tightness test for detection of<br>holes, physical dimensions and<br>physical properties were performed<br>on the test glove to test its<br>properties.<br>The results showed each property of<br>the test glove was acceptable under<br>this test condition. | Items: Water lack,<br>Batch size: 35000<br>Inspectional level: I<br>AQL: 2.5<br>Sample Demand: 125<br>Criterion: ≤7 | Number of Conforming:<br>125 Glove<br>Number of Non-<br>confirming: 0 Glove | | | | | | | | | | | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------| | Physical Dimensions Test:<br>Sampling procedures for<br>inspection by attributes Part 1:<br>Sampling schemes indexed by<br>acceptance quality limit (AQL)<br>for lot-by-lot inspection (ISO<br>2859-1:1999)<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application (ASTM<br>D6319 - 19)<br>Standard Practice for Rubber—<br>Measurement of Dimensions<br>(ASTM D 3767-03(2014)) | | Items: Physical dimension test<br>Batch size: 35000<br>Inspectional Level: S-2<br>AQL: 4.0<br>Sample Demand: 13 | The test result was<br>considered to be<br>acceptable. | | | | | | | | | | | | | | | | Determination of Physical<br>Properties:<br>Sampling procedures for<br>inspection by attributes Part 1:<br>Sampling schemes indexed by<br>acceptance quality limit (AQL) | | Items Before Aging After Accelerated<br>Aging Tensile<br>Strength Ultimate<br>Elongation Tensile<br>Strength Ultimate<br>Elongation Physical<br>Requirements ≥14MPa ≥500% ≥14MPa ≥400% | | | | | | | | | | | | | | | The test result was<br>considered to be<br>acceptable. | {9}------------------------------------------------ # FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD | for lot-by-lot inspection (ISO 2859-1:1999)<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application (ASTM D6319 - 19)<br>Standard Test Methods for<br>Vulcanized Rubber and<br>Thermoplastic Elastomers—<br>Tension (ASTM D 412-06a(2013))<br>Surface Powder Test of<br>"powder-free" gloves:<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application (ASTM D6319 - 19)<br>Standard Test Method for<br>Rubber—Deterioration in an Air<br>Oven (ASTM D 573-04(2015))<br>Medical gloves - Determination<br>of removable surface powder<br>ISO 21171-2006<br>Standard Test Method for<br>Residual Powder on Medical<br>Gloves ASTM D6124 -<br>06(2017) | Inspection Level | S-2 | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------|--------------------------------------------------------------------------------------------------------------------------------------------------|----|----| | | AQL | 4.0 | | | | | | Sample Size Code Letter | E | | | | | | Batch Size | 35000 | | | | | | Sample Demand | 13 | | | | | | Number of Non-conforming | ≤1 | ≤1 | ≤1 | ≤1 | | | Powder-free Synthetic Exam<br>3 sets of 2 gloves/batch, Average: 0.63mg/glove | | Analyte: Residual Powder<br>Result: 0.18mg/glove<br>The results showed each property of the test glove was acceptable under this test condition. | | | {10}------------------------------------------------ ### 9. Clinical Test Conclusion Clinical testing is not needed for this device. ### 10. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.