(87 days)
The Blue Nitrile Exam 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 Blue Nitrile Exam 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 provided document is a 510(k) summary for "Blue Nitrile Exam Gloves" (K211341). It details the device's technical specifications and comparisons to a predicate device, as well as the results of non-clinical performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility - Skin Sensitization (ISO 10993-10) | Grades less than 1 (no sensitization) | All grades are 0. All animals survived and no abnormal signs were observed. |
| Biocompatibility - Skin Irritation (ISO 10993-10) | Primary irritation index 0-0.4 (Negligible response) | Primary irritation index is 0. Response categorized as negligible. |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | Viability reduced to <70% of blank indicates cytotoxic potential (i.e., >70% viability is acceptable) | Viability of 100% test article extract is 86.5%. |
| Residual Powder (ASTM D6124-06) | Powder residue limit of 2.0 mg | 0.03 mg |
| Freedom from Holes (ASTM D5151-06) | Samples: 125 gloves; AQL: 2.5 (ISO 2859); Criterion ≤ 7 gloves for water leakage | No glove water leakage found |
| Dimensions (ASTM D6319-10) | S: width 80±10mm, Length ≥220 mmM: width 95±10mm, Length ≥230 mmL: width 110±10mm, Length ≥230 mmXL: width 120±10mm, Length ≥230 mmThickness: Finger ≥0.05 mm, Palm ≥0.05 mm | S: width 83-86 mm, Length 253-266 mmM: width 96-98 mm, Length 243-262 mmL: width 106-110 mm, Length 247-254 mmXL: width 112-118 mm, Length 245-252 mmThickness: Finger 0.09-0.11 mm, Palm 0.08-0.11 mm |
| Physical Properties - Before Aging (ASTM D6319-10) | Tensile Strength ≥ 14MPaUltimate Elongation ≥ 500% | Tensile strength 15.7-17.7 MPaUltimate Elongation 532.284% - 552.072% |
| Physical Properties - After Accelerated Aging (ASTM D6319-10) | Tensile strength ≥ 14MPaUltimate Elongation ≥ 400% | Tensile strength 15.2-17.8 MPaUltimate Elongation 525.947% - 548.352% |
2. Sample Size Used for the Test Set and Data Provenance
- Skin Sensitization, Skin Irritation, Cytotoxicity: The document specifies "All animals survived" for irritation/sensitization and mentions "L-929 cells" for cytotoxicity, indicating in vitro and in vivo (animal) testing. Specific sample numbers (of animals or cell cultures) are not explicitly stated.
- Freedom from Holes: 125 gloves.
- Residual Powder, Dimensions, Physical Properties (Tensile Strength, Ultimate Elongation): The sample sizes for these tests are not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin for the test data, nor whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This device is a medical glove. The ground truth for its performance is established through adherence to recognized international standards (ISO, ASTM) and established measurement protocols, not typically through human expert consensus in the way an AI diagnostic tool would be evaluated. Therefore, no human experts were explicitly used to "establish the ground truth" for this type of test set in the conventional sense of clinical interpretation. The "ground truth" is defined by the objective measurement criteria outlined in the standards.
4. Adjudication Method for the Test Set
- Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation studies. Since this submission is for a medical glove and relies on standardized non-clinical performance testing, such adjudication methods are not applicable and were not used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This is a non-clinical submission for a medical glove, not an AI-assisted diagnostic device that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This is a medical glove, not an algorithm or AI device. The tests performed are standalone in the sense that they assess the glove's physical and biological properties directly, without human interpretation as part of the core performance measurement.
7. Type of Ground Truth Used
- The ground truth for this medical device is based on predefined objective criteria and measurement protocols specified in recognized international standards (ASTM D6124, ASTM D5151, ASTM D6319, ISO 10993-10, ISO 10993-5). It involves physical measurements (dimensions, tensile strength, elongation, powder content, water leakage) and biological assays (cytotoxicity, irritation, sensitization) that have established acceptance limits.
8. Sample Size for the Training Set
- Not applicable. This is a medical glove; there is no "training set" in the context of machine learning or AI models. Its performance is evaluated through manufacturing quality control and specific batch testing against established standards.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
July 29, 2021
Jiangxi Surefine Medical Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 China
Re: K211341
Trade/Device Name: Blue Nitrile Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 6, 2021 Received: July 12, 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 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.
For Clarence W. Murray, III, PhD 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) K211341
Device Name Blue Nitrile Exam Gloves
Indications for Use (Describe)
The Blue Nitrile Exam 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
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Jiangxi Surefine Medical Co., Ltd. Address: Jinshan Rd., Yugan Hi-tech Industrial Park, Shangrao,Jiangxi Province, 335100, China Phone Number: +86-13805860705 Contact: Steve Zhu Date of Preparation: 2021.04.21
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: Blue Nitrile Exam Gloves 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
Ever Global (Vietnam) Enterprise Corp Manufacturer: Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
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5.0 Intended use
The Blue Nitrile Exam 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 Blue Nitrile Exam 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 Technological Characteristics Comparison
| Item | Proposed device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K211341 | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Blue Nitrile Exam 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, Blue Nitrile Exam 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 | |||||
| S | M | L | XL | |||||
| Length, mm | 220 | 230 | 230 | 230 | min | |||
| Width, mm | 80 | 95 | 110 | 120 | $\pm 10$ | |||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | Analysis 1 |
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 holeswhen tested inaccordance withASTMD5151AQL=2.5 | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | SAME | ||
| Powder Content | 0.03 | Meet the requirements ofASTM 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 Blue Nitrile Exam 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 were comparable.
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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 |
Table4 Biocompatibility Testing Comparison
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 ISO10993 assessespossible contacthazards fromchemicals released frommedical devices, | Skin SensitizationTest:provided grades less than 1,otherwisesensitization. | All grades are 0.All animals survived and noabnormal signs were observedduring the study. |
| 2 | 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 86.5%It means the proposed devicehave no potential toxicity to L-929 in the MTT method |
| 4 | 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 | 0.03mg |
| 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 agingTensile strength | 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% |
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| Ultimate Elongation ≥500%After AcceleratedAgingTensile strength ≥14MPaUltimate Elongation ≥400%Powder-free Residue:pl. Refer to No. 4 intable 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.