(114 days)
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
This document describes the performance testing for a medical device: "Nitrile Patient Examination Glove" (K222527). The tests demonstrate that the device meets established acceptance criteria, primarily through non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility - Skin Sensitization (ISO 10993-10:2010) | Grades less than 1, otherwise sensitization. |
| Biocompatibility - Skin Irritation (ISO 10993-10:2010) | 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. |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | Viability reduced to <70% of the blank indicates cytotoxic potential. |
| Residual Powder Content (ASTM D6124-06 (Reapproved 2017)) | Powder residue limit of 2.0 mg/glove. |
| Freedom from Holes (ASTM D5151-06 (Reapproved 2015)) | Samples number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤7 gloves for water leakage. |
| Dimensions (ASTM D6319-10 (Reapproved 2015)) | Length: S $\ge$ 220 mm; M, L, XL $\ge$ 230 mm. Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10. Thickness (mm): Finger $\ge$ 0.05; Palm $\ge$ 0.05. |
| Physical Properties - Before Aging (ASTM D6319-10) | Tensile strength: $\ge$ 14 MPa. Ultimate Elongation: $\ge$ 500%. |
| Physical Properties - After Accelerated Aging (ASTM D6319-10) | Tensile strength: $\ge$ 14 MPa. Ultimate Elongation: $\ge$ 400%. |
2. Sample sizes used for the test set and the data provenance
- Freedom from Holes: 125 gloves were tested.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity), Powder Content, Dimensions, Physical Properties: The document does not specify the exact sample size for each of these tests, but it indicates that tests were performed according to the referenced ASTM and ISO standards, which typically include specific sampling plans. For instance, ASTM D6319 for dimensions requires a certain number of gloves per lot for testing.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the submitter's address is in China and the nature of the device (examination gloves), it is likely that the testing was conducted by or on behalf of the manufacturer, presumably in adherence to international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes technical and biological performance testing for medical gloves, not an AI or imaging device that requires expert human interpretation for ground truth. Therefore, there were no "experts" in the sense of radiologists or clinicians establishing ground truth for diagnostic accuracy in a test set. The "ground truth" for these tests is defined by the objective measurements obtained through standardized laboratory procedures (e.g., tensile strength, dimensions, chemical analysis, in vitro/in vivo biocompatibility assays).
4. Adjudication method for the test set
Not applicable. As noted above, this device did not involve human interpretation or subjective assessment that would require an adjudication method. The test results are quantitative measurements against predefined criteria.
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 is not an AI/imaging device, therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/imaging device, therefore, no standalone algorithm performance testing was conducted.
7. The type of ground truth used
The ground truth used for these tests is based on:
- Physical Measurements: Objective measurements of dimensions (length, width, thickness), tensile strength, and elongation according to ASTM standards.
- Chemical Analysis: Quantitative measurement of residual powder content.
- Biological Assays: Standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization on animals) biological tests using established protocols (ISO 10993 standards) where the "ground truth" is the observed biological response compared to predefined thresholds.
- Defect Detection: Water leakage test for freedom from holes.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no training set in the AI context. The manufacturing process for gloves is subject to quality control and batch testing, rather than an AI training and validation paradigm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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December 14, 2022
PingAn Medical Products Co.,Ltd. % Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K222527
Trade/Device Name: Nitrile Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 14, 2022 Received: November 14, 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.
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
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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,
Bifeng Qian -S
Bifeng Qian, M.D., 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222527
Device Name Nitrile Patient Examination Glove
Indications for Use (Describe)
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands 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)
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510(k) Summary (K222527)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
PingAn Medical Products Co.,Ltd. Name: Address: Zheji road, High-tech Industrial Zone of Hukou County, Jiujiang City, Jiangxi Province, China Phone Number: +86-15247135174 Contact: Zhou Ziyu Date of Preparation: 2022.07.20
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Nitrile Patient Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): 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: Yingxiang Glove Products Co., Ltd. Device: Nitrile Patient Examination Gloves 510(k) number: K211914
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5.0 Indication for Use
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device(K222527) | Predicated Device(K211914) | Remark |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use /Indication for Use | The Nitrile PatientExamination Glove is anon-sterile disposabledevice intended formedical purposes that isworn on the examiner'shands or finger to preventcontamination betweenpatient and examiner. | The Nitrile PatientExamination Gloves is adisposable deviceintended for medical purposesthat is worn on theexaminer's hands to preventcontamination betweenpatient and examiner. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| LabelingInformation | Single-use indication,powder free, device color,device name, glove sizeand quantity, Nitrile GlovePowder Free Blue,Non-Sterile | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Disposable Powder FreeNitrile ExaminationGlove, Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
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| Size | |||||||
|---|---|---|---|---|---|---|---|
| PredicateDevice(K211914) | Designation | S | M | L | XL | Tolerance | |
| 9-inch | Length, mm | 220 | 230 | 230 | 230 | min | |
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| 12-inch | Length, mm | 220 | 230 | 230 | 230 | min | |
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| 9-inch/12-inch | FingerPalm | 0.05 | min | ||||
| 0.05 | min | ||||||
| SubjectDevice | 12 inch | Designation | S | M | L | XL | Tolerance |
| Length, mm | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| SIMILAR |
Analysis: The physical dimensions of subject device are same with the 12 inch ones of the predicate device, and they all meet the requirements of ASTM D6319-19.
| Item | Subject device (Pending) | Predicated device (K211914) | Remark | |
|---|---|---|---|---|
| Colorant | Blue | Blue | Same | |
| Physical Properties | Before AgingTensile Strength | 14MPa, min | 14MPa, min | Same |
| Before AgingUltimate Elongation | 500% min | 500% min | Same | |
| After AgingTensile Strength | 14MPa, min | 14MPa, min | Same | |
| After AgingUltimate Elongation | 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 |
Table3 Performance Comparison
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| Powder Content | 0.24 mg/glove | Meet the requirements of SimilarASTM D6124 |
|---|---|---|
| ---------------- | --------------- | ------------------------------------------------ |
Table4 Safety Comparison
| Item | Subject device (Pending) | Predicated device (K211914) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) | Under the conditions of the study, not an irritant | ||
| Sensitization (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) | Under conditions of the study, not a sensitizer. | Comply with ISO10993-10 | Same | |
| Cytotoxicity (ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity) | Under conditions of the study, device extract is not cytotoxic | Comply with ISO10993-5 | Similar | |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
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.
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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 | Skin SensitizationTest: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 | medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | 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 10993-5:2009Biological Evaluation OfMedical Devices - Part5: Tests For In VitroCytotoxicity | This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. | 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 74.2%It means the proposed device have potential toxicity to L-929 in the MTT method |
| 4 | ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powder onMedical Gloves | This standard is designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves | powder residue limit of 2.0 mg | 0.24 mg /glove |
| 5 | ASTMD5151-06(Reapproved2015), Standard TestMethod for Detection ofHoles in Medical Gloves. | This test method covers the detection of holes in medical gloves. | Samples number: 125 glovesAQL: 2.5 (ISO 2859)Criterion ≤7 gloves for water leakage | 0 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 $\ge$ 220 mmM: width 95±10mmLength $\ge$ 230 mmL: width 110±10mmLength $\ge$ 230 mmXL: width 120±10mmLength $\ge$ 230 mmThickness:Finger $\ge$ 0.05 mmPalm $\ge$ 0.05 mm | Lot no.:JX220117Dimensions:S: width: 84-86 mmLength 295-304 mmThickness:Finger 0.136-0.155 mmPalm 0.109-0.125 mmM: width 94-97 mmLength 296-302mmThickness:Finger 0.136-0.155 mmPalm 0.109-0.125 mmL: width 104-107 mmLength 297-302 mmThickness:Finger 0.150-0.171 mmPalm 0.112-0.125 mmXL: width 113-117 mmLength 296-303 mmThickness:Finger 0.154-0.168 mmPalm 0.113-0.129 mmPhysical properties:Before agingTensile strength 17.9-40.5MPaUltimate Elongation 508.945% -574.078%After Accelerated AgingTensile strength 14.2-27.1 MPaUltimate Elongation 402.900% -538.033%Powder-free Residue:pl. Refer to No. 4 in table 5Physical properties:Before agingTensile strength $\ge$ 14MPaUltimate Elongation $\ge$ 500%After AcceleratedAgingTensile strength $\ge$ 14MPaUltimate Elongation $\ge$ 400%Powder-free Residue:pl. Refer to No. 4 intable 5 |
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9.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
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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.