(58 days)
The Disposable Nitrile Powder-Free 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 Powder-Free 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 provided is a 510(k) summary for Disposable Nitrile Powder-Free Examination Gloves. It details the safety and effectiveness information, comparing the proposed device to a legally marketed predicate device. The information provided heavily focuses on non-clinical performance testing rather than studies involving human readers or AI.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| No. | Name of the Test Methodology / Standard | Acceptance Criteria | Results |
|---|---|---|---|
| 1 | ISO 10993-10:2010 (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 | ISO 10993-10:2010 (Skin Irritation) | Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | The viab.% 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. | Viab.% of 100% test article extract is 17.1%. (This means the proposed device has potential toxicity to L-929 in the MTT method, but Analysis 3 clarifies this is mitigated by systemic toxicity tests). |
| 4 | ISO 10993-11: 2017 (Systemic Toxicity) | Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable. | There was no evidence of systemic toxicity from the extract. |
| 5 | ASTM D6124-06 (Residual Powder) | powder residue limit of 2.0 mg | 0.15-0.19 mg /glove |
| 6 | ASTM D5151-06 (Holes in Medical Gloves) | Samples number: 125 gloves; AQL: 2.5 (ISO 2859); Criterion ≤7 gloves for water leakage | no glove water leakage found |
| 7 | ASTM D6319-10 (Nitrile Examination Gloves) | Dimensions: S: width 80±10mm, Length ≥ 220 mm; M: width 95±10mm, Length ≥ 230 mm; L: width 110±10mm, Length ≥ 230 mm; XL: width 120±10mm, Length ≥ 230 mm. Thickness: Finger ≥ 0.05 mm, Palm ≥ 0.05 mm. Physical properties: Before aging: Tensile strength ≥ 14MPa, Ultimate Elongation ≥ 500%; After Accelerated Aging: Tensile strength ≥ 14MPa, Ultimate Elongation ≥ 400%. | Dimensions (Lot no.:210515): S: width: 85-87 mm, Length 247-253 mm; M: width 88-96 mm, Length 242-257 mm; L: width 90-99 mm, Length 240-254 mm; XL: width 110-115 mm, Length 245-253 mm. Thickness (Lot no.:210515): Finger 0.09-0.21 mm, Palm 0.06-0.15 mm. Physical properties (Lot no.:210515): Before aging: Tensile strength 14.1-22.5 MPa, Ultimate Elongation 503.274% - 670.613%; After Accelerated Aging: Tensile strength 14.6-20.8 MPa, Ultimate Elongation 411.403% - 592.683%. (Similar results reported for other lots 210518, 210520) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set:
- For the hole detection test (ASTM D5151-06), the sample size specified in the acceptance criteria is 125 gloves. The actual results state that "no glove water leakage found," implying 125 gloves were tested.
- For biocompatibility tests (ISO 10993 series), the specific number of animals or samples is not explicitly stated in the summary, but standard protocols for these tests involve specific sample sizes (e.g., animal groups for irritation/sensitization, cell cultures for cytotoxicity).
- For material properties (tensile strength, elongation, dimensions), the results are provided for specific "Lot no." (e.g., 210515, 210518, 210520), suggesting samples were taken from these production lots. The exact sample size per lot for these physical tests is not detailed in the summary.
- Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being Shandong Maida Medical Technology Co.,Ltd. in China. The studies are non-clinical performance tests, meaning they are not conducted on human subjects and therefore the concepts of "retrospective or prospective" as typically applied to clinical studies are not directly applicable. These are laboratory/bench tests to confirm product specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a new medical device submission for examination gloves, which is a Class I device. The "ground truth" for this type of device is established through adherence to recognized international and national standards (ISO, ASTM) for material properties, biocompatibility, and physical characteristics. There is no mention of "experts" in the context of human data interpretation or labeling for AI models. The "ground truth" here is the pass/fail criteria defined by these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or AI where adjudication of conflicting opinions would be necessary. The tests are based on objective measurements and established standard protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This submission is for medical examination gloves, which are physical devices, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
The ground truth for this device's performance is based on accepted international and national standards (e.g., ISO 10993 series for biocompatibility, ASTM D6124 for residual powder, ASTM D5151 for holes, ASTM D6319 for physical properties). The device's performance is compared against the specific numerical and qualitative criteria defined within these standards.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for a physical medical device like an examination glove. These are non-clinical performance tests to ensure the product meets manufacturing and safety specifications.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
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June 22, 2022
Shandong Maida Medical Technology Co.,Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608.No.738.Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K221192
Trade/Device Name: Disposable Nitrile Powder-Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 18, 2022 Received: April 25, 2022
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.
Bifeng Qian, M.D., 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221192
Device Name
Disposable Nitrile Powder-Free Examination Gloves
Indications for Use (Describe)
The Disposable Nitrile Powder-Free 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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510(k) Summary K221192
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: Shandong Maida Medical Technology Co.,Ltd. Address: Room 102, Eastern building, No.166, South 1st Road, Development zone, Dongying, Shandong, China Phone Number: +86-13853370291 Contact: Kitty xu Date of Preparation: 2022.04.18
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 Powder-Free Examination Gloves
Common name: Patient Examination Gloves
Classification name: Non-powdered patient examination glove
S, M, L, XL Model(s):
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I General Hospital Panel:
4.0 Predicate device information
Ever Global (Vietnam) Enterprise Corp Manufacturer:
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Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
5.0 Indications For Use
The Disposable Nitrile Powder-Free 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 Powder-Free 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 |
| Indications for Use | The Disposable NitrilePowder-Free ExaminationGloves is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Disposable PowderFree Nitrile ExaminationGlove, White/ Blue/ Black/Pink Color is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient 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 sizeand quantity, DisposableNitrile Powder-FreeExamination Gloves, | Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposablePowder Free NitrileExamination Glove, | Same |
Table1-General Comparison
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| Non******************************************************************************************************************************************************************************راز الاستق | VIVIIV |
|---|
| PredicateDevice(K171422) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Length, mm | XS230 | S230 | M230 | L230 | XL230 | 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 | ||||
| Length, mm | S220 | M230 | L230 | XL230 | min | ||
| Width, mm | 80 | 95 | 110 | 120 | $\pm 10$ | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Analysis 1 |
Table2 Device Dimensions Comparison
Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
| 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 | Comply with ASTM D6319 | SAME | ||
| Freedom from Holes | Be free from holes when tested in accordance withASTMD5151AQL=2.5 | Be free from holes when tested in accordance withASTMD5151 AQL=2.5 | SAME | ||
| Powder Content | 0.15-0.19 | Meet the requirements ofASTM D6124 | SIMILAR |
Table3 Performance Comparison
Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect the safety 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 withISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not asensitizer. | |||
| Cytotoxicity | Under the conditions of the study,the device is potentially cytotoxic | Comply withISO10993-5 | Analysis3 | |
| Systemictoxicity | Under the conditions of the study,the device does not elicit a systemictoxicity response in the modelanimal. | Complies with ISO10993-11 Third edition2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA'SRequirement | SAME |
Table4 Safety Comparison
Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe.
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.
| 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 ISO10993 assessespossible contacthazards fromchemicalsreleased from | Skin SensitizationTest:providedgrades less than 1,otherwisesensitization. | All grades are 0.All animals were survived and noabnormal signs were observedduring the study. |
| 2 | medical devices,which mayproduce skin andmucosal irritation,eye irritation orskin sensitization. | Skin Irritation Test:If the primary irritationindex is 0-0,4, theresponse category isNegligible.0,5-1,9 means slight2-4,9 means moderate5-8 means severe | The primary irritation index is 0.The response of the proposeddevice was categorized asnegligible under the testcondition | |
| 3 | ISO 10993-5:2009Biological Evaluation OfMedical Devices - Part5: Tests For In VitroCytotoxicity | This part of ISO10993 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 17.1%It means the proposed devicehave potential toxicity to L-929 inthe MTT method |
| 4 | ISO 10993-11: 2017Biological evaluation ofmedical devices — Part11: Tests for systemictoxicity | To evaluate thepotential formedical devicematerials to causeadverse systemicreactions. | Within the monitoringperiod (72 h), if thetoxicosis response oftesting group is notgreater than that ofcontrol group, thetesting sample isregarded asacceptable. | There was no evidence ofsystemic toxicity from the extract. |
| 5 | ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powder onMedical Gloves | This standard isdesigned todetermine theamount ofresidualpowder (orfilter-retainedmass) foundon medical gloves | powder residue limit of2.0 mg | 0.15-0.19 mg /glove |
| 6 | 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 |
| 7 | 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 $\geq$ 220 mmM: width 95±10mmLength $\geq$ 230 mmL: width 110±10mmLength $\geq$ 230 mmXL: width 120±10mmLength $\geq$ 230 mmThickness:Finger $\geq$ 0.05 mmPalm $\geq$ 0.05 mm | N.A.Please refer to No. 5 in table 5Lot no.:210515Dimensions:S: width: 85-87 mmLength 247-253 mmM: width 88-96 mmLength 242-257 mmL: width 90-99 mmLength 240-254 mmXL: width 110-115 mmLength 245-253 mmThickness:Finger 0.09-0.21 mmPalm 0.06-0.15 mm |
| Physical properties:Before agingTensile strength $\geq$14MPaUltimate Elongation $\geq$500%After AcceleratedAgingTensile strength $\geq$14MPaUltimate Elongation $\geq$400%Powder-free Residue:pl. Refer to No. 4 intable 5 | Physical properties:Before agingTensile strength 14.1-22.5 MPaUltimate Elongation 503.274% -670.613%After Accelerated AgingTensile strength 14.6-20.8 MPaUltimate Elongation 411.403% -592.683%Powder-free Residue:pl. Refer to No. 4 in table 5Lot no.:210518Dimensions:S: width: 84-86 mmLength 248-256 mmM: width 95-96 mmLength 237-266 mmL: width 105-108 mmLength 257-262 mmXL: width 114-117 mmLength 252-262 mmThickness:Finger 0.10-0.12mmPalm 0.07-0.08mm |
Table 5 Summary of Non-Clinical Performance Testing
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| Physical properties:Before agingTensile strength 15.2-29.8 MPaUltimate Elongation 500.492% -593.853%After Accelerated AgingTensile strength 14.1-23.8MPaUltimate Elongation 451.751% -597.368%Powder-free Residue:pl. Refer to No. 4 in table 5Lot no.:210520Dimensions:S: width: 84-87 mmLength 244-257 mmM: width 93-98 mmLength 245-260 mmL: width 104-110mmLength 250-263 mmXL: width 114-119 mmLength 252-260 mmThickness:Finger 0.10-0.12 mmPalm 0.06-0.08 mmPhysical properties:Before agingTensile strength 14.4-23.9MPaUltimate Elongation 501.484% -547.660%After Accelerated AgingTensile strength 14.2-23.9 MPaUltimate Elongation 492.901% -599.996%Powder-free Residue:pl. Refer to No. 4 in table 5 | ||
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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.