(88 days)
The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The document describes the acceptance criteria and the results of the non-clinical performance testing for the "Disposable Nitrile Examination gloves."
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Name of the Test Methodology / Standard | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| 1 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Skin Sensitization Test) | Provided grades less than 1, otherwise sensitization. | All grades are 0. All animals survived and no abnormal signs were observed. |
| 2 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Skin Irritation Test) | If the primary irritation index is 0-0.4, the response category is Negligible. | The primary irritation index is 0. The response was categorized as negligible. |
| 3 | ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | The viability (%) of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viability (%) of 100% test article extract is 86.5%. The proposed device has no potential toxicity to L-929 in the MTT method. |
| 4 | ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves | Powder residue limit of 2.0 mg. | 0.16 mg |
| 5 | ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves. | Samples number: 125 gloves, AQL: 2.5 (ISO 2859), Criterion $\le$ 7 gloves for water leakage. | No glove water leakage found. |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Dimensions - S) | Width 80 $\pm$ 10mm, Length $\ge$ 220 mm | Width: 83-86 mm, Length 253-266 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Dimensions - M) | Width 95 $\pm$ 10mm, Length $\ge$ 230 mm | Width 96-98 mm, Length 243-262 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Dimensions - L) | Width 110 $\pm$ 10mm, Length $\ge$ 230 mm | Width 106-110 mm, Length 247-254 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Dimensions - XL) | Width 120 $\pm$ 10mm, Length $\ge$ 230 mm | Width 112-118 mm, Length 245-252 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Thickness) | Finger $\ge$ 0.05 mm, Palm $\ge$ 0.05 mm | Finger 0.09-0.11 mm, Palm 0.08-0.11 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Physical properties - Before Aging) | Tensile strength $\ge$ 14MPa, Ultimate Elongation $\ge$ 500% | Tensile strength 15.7-17.7 MPa, Ultimate Elongation 532.284% - 552.072% |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Physical properties - After Accelerated Aging) | Tensile strength $\ge$ 14MPa, Ultimate Elongation $\ge$ 400% | Tensile strength 15.2-17.8 MPa, Ultimate Elongation 525.947% - 548.352% |
2. Sample Size Used for the Test Set and Data Provenance:
- Skin Sensitization, Skin Irritation, and Cytotoxicity Tests: The number of biological samples (animals or cells) used is not explicitly stated, but the results refer to "All animals" and "L-929 cells." The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified.
- Residual Powder, Freedom from Holes, Dimensions, and Physical Properties Tests: These tests are performed on the device itself, not human or animal subjects in the same way.
- Freedom from Holes: 125 gloves were tested.
- For other physical property tests (e.g., dimensions, tensile strength), the exact number of gloves or samples is not explicitly mentioned, but the results represent the performance of the device samples.
- The provenance of the data (e.g., country of origin of the data, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This document describes non-clinical performance testing for a medical device (examination gloves). The ground truth for these tests is established by adhering to established international and national standards (ISO 10993-10, ISO 10993-5, ASTM D6124, ASTM D5151, ASTM D6319) and their defined methodologies and acceptance criteria. There is no mention of "experts" in the sense of clinical reviewers for diagnostic accuracy, as this is not a diagnostic device. The "ground truth" is the objective measurement against the specified standard.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study involving human interpretation of data requiring adjudication. The tests involve objective measurements and comparisons against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This is a non-clinical performance study for examination gloves, not an AI-assisted diagnostic or interpretative system that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, a standalone performance study in the context of an algorithm or AI system was not done. This device is an examination glove, and the tests performed are physical and biological material property tests.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on established industry standards and specifications (e.g., ISO 10993-10, ISO 10993-5, ASTM D6124, ASTM D5151, ASTM D6319). These standards define the acceptable range or criteria for various physical and biological properties of the device.
8. Sample Size for the Training Set:
Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning/AI model.
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Nov 5, 2021
Fujian Yuanxin Safety Protection Technology Co., Ltd. Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608.No.738.Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K212485
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: July 30, 2021 Received: August 9, 2021
Dear Boyle Wang:
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.
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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 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, 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
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Indications for Use
510(k) Number (if known) K212485
Device Name Disposable Nitrile Examination gloves
Indications for Use (Describe)
The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands 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)
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K212485 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Fujian Yuanxin Safety Protection Technology Co., Ltd. Address: Xiacun Medical Industry Zone,Zherong County,Ningde,Fujian, 355300, China Phone Number: +86-593-8311666 Contact: Alan Wu Date of Preparation: 2021.07.30
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Disposable Nitrile Examination gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
FROM THE PIT
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5.0 Intended use
The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
7.0 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| 510(k) number | Pending | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable Nitrile Examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Disposable Nitrile Examination gloves, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Disposable Powder Free Nitrile Examination Glove, Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K171422) | XS | S | M | L | XL |
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| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
|---|---|---|---|---|---|---|---|
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Proposed Device | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm 10$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Analysis1 |
Table3 Performance Comparison
| Item | Proposed device | Predicated device | Remark | ||
|---|---|---|---|---|---|
| Colorant | blue | White/ Blue/ Black/ Pink | Analysis2 | ||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | 14MPa, min | SAME |
| UltimateElongation | 500%min | 500%min | SAME | ||
| AfterAging | TensileStrength | 14MPa, min | 14MPa, min | SAME | |
| UltimateElongation | 400%min | 400%min | SAME | ||
| Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | |||
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | SAME | ||
| Powder Content | 0.16 | Meet the requirements of ASTM D6124 | SIMILAR |
Analysis1: The proposed device has different sizes to the predicate device, but all proposed devices are conducted the properties test, the test results shown that the sizes comply with the requirements of standard ASTM D6319-19, Standard Specification For Disposable Nitrile Examination gloves For Medical Application.
Analysis2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility and performance tests, the test results shown that the color difference does not affect the safety and efficacy of proposed device.
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| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | Comply with ISO10993-5 | SIMILAR | |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Biocompatibility Testing Comparison Table4
8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
Table 5 Summary of Non-Clinical Performance Testing
| No. | Name of the TestMethodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010Biological Evaluation OfMedical Devices - Part10: Tests For IrritationAnd Skin Sensitization. | This part of ISO 10993 assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test:provided grades less than 1, otherwise sensitization. | All grades are 0.All animals were survived and no abnormal signs were observed during the study. |
| 2 | Skin Irritation Test:If the primary irritation index is 0-0,4, the response category is Negligible.0,5-1,9 means slight2-4,9 means moderate5-8 means severe | The primary irritation index is 0.The response of the proposed device was categorized as negligible under the test condition | ||
| 3 | ISO 10993-5:2009Biological Evaluation OfMedical Devices - Part5: Tests For In VitroCytotoxicity | This part of ISO 10993 describestest methods toassess the in vitrocytotoxicity ofmedical devices. | The viab.% of the100% extract of thetest article is the finalresult, and if viability isreduced to $<70%$ ofthe blank, it hascytotoxic potential. | Viab.% of 100% test articleextract is 86.5%It means the proposed devicehave no potential toxicity toL-929 in the MTT method |
| 4 | ASTM D6124-06(Reapproved2017),Standard Test Methodfor Residual Powder onMedical Gloves | This standard isdesigned todetermine theamount ofresidualpowder (orfilter-retainedmass) foundon medical gloves | powder residue limit of2.0 mg | 0.16mg |
| 5 | ASTMD5151-06(Reapproved2015), Standard TestMethod for Detection ofHoles in Medical Gloves. | This test methodcovers thedetection of holesinmedical gloves. | Samples number: 125glovesAQL: 2.5 (ISO 2859)Criterion $≤$ 7 glovesfor water leakage | no glove water leakage found |
| 6 | ASTMD6319-10(Reapproved2015),StandardSpecification For NitrileExamination Gloves ForMedical Application. | This specificationcovers certainrequirements fornitrile rubbergloves used inconductingmedicalexaminations anddiagnostic andtherapeuticprocedures. | Sterility: no needFreedom from holes:pl. Refer to No. 5 intable 5Dimensions:S: width 80 $±$ 10mmLength $≥$ 220 mmM: width 95 $±$ 10mmLength $≥$ 230 mmL: width 110 $±$ 10mmLength $≥$ 230 mmXL: width 120 $±$ 10mmLength $≥$ 230 mmThickness:Finger $≥$ 0.05 mmPalm $≥$ 0.05 mmPhysical properties:Before aging | N.A.Please refer to No. 5 in table 5Dimensions:S: width: 83-86 mmLength 253-266 mmM: width 96-98 mmLength 243-262 mmL: width 106-110 mmLength 247-254 mmXL: width 112-118 mmLength 245-252 mmThickness:Finger 0.09-0.11 mmPalm 0.08-0.11 mmPhysical properties:Before agingTensile strength 15.7-17.7 MPaUltimate Elongation 532.284% -552.072%After Accelerated Aging |
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| Ultimate Elongation $\ge$ 500%After Accelerated AgingTensile strength $\ge$ 14MPaUltimate Elongation $\ge$ 400%Powder-free Residue:pl. Refer to No. 4 in table 5 | Tensile strength 15.2-17.8 MPaUltimate Elongation 525.947% - 548.352%Powder-free Residue:pl. Refer to No. 4 in table 5 | |
|---|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------ |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10.0 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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.