(223 days)
The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Nitrile Examination Gloves are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.
This document is a 510(k) Pre-Market Notification for Nitrile Examination Gloves (K210706). It reports on non-clinical testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions | Length (mm): ≥ 230; Width (mm): S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10; Thickness (mm): Finger: ≥ 0.05; Palm: ≥ 0.05 | Length: ≥ 230; Width: S: 80-84, M: 95-99, L: 108-111, XL: 117-121; Thickness: Finger: 0.08-0.10, Palm: 0.06-0.08 (Pass) |
| ASTM D5151 | Watertightness | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.02 mg (Pass) |
| ASTM D6319 (ASTM D412) | Physical properties (Before Aging) | Tensile Strength: ≥ 14 MPa; Ultimate Elongation: ≥ 500 % | Tensile Strength: 26-35; Ultimate Elongation: 509-545 (Pass) |
| ASTM D6319 (ASTM D412) | Physical properties (After Aging) | Tensile Strength: ≥ 14 MPa; Ultimate Elongation: ≥ 400 % | Tensile Strength: 19-36; Ultimate Elongation: 447-510 (Pass) |
| ISO 10993-5 | Cytotoxicity | Cytotoxic (Note: The acceptance criteria here is for the study to detect cytotoxicity, not to "pass" by being non-cytotoxic. The reported result then indicates observation of slight toxicity.) | Under conditions of the study, show slight potential toxicity to L-929 cells (This is the reported result, not necessarily a "pass" in the typical sense, but an observation as per the test.) |
| ISO 10993-11 | Acute systemic toxicity | Non-toxicity | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a separate "test set" in the context of an algorithm or AI model. Instead, it refers to samples tested for physical and biological properties of the nitrile gloves.
- Sample Size for Physical and Chemical Tests:
- Watertightness Test (ASTM D5151): 125 leaks (implied sample size tested to achieve 0/125 leaks).
- Other tests like physical dimensions, powder content, and physical properties (tensile strength, elongation) would have required a specific number of glove samples, but these exact numbers are not detailed in this summary. ASTM standards typically specify sample sizes for these tests.
- Data Provenance: The document does not specify the country of origin for the samples used in these non-clinical tests. The tests are for the Nitrile Examination Gloves manufactured by Niujian Technology Co., Ltd. (China). The tests themselves were conducted according to international standards (ASTM, ISO). The tests are prospective in the sense that they are performed on samples of the manufactured device to assess its compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes the testing of a physical medical device (nitrile gloves), not an AI algorithm. Therefore, concepts like "ground truth established by experts" are not applicable in the same way. The "ground truth" for these tests is defined by the technical specifications and limits set by the ASTM and ISO standards (e.g., a glove must have a tensile strength of X MPa, or less than Y mg of powder). The results are objectively measured against these numerical or qualitative criteria by laboratory technicians.
4. Adjudication Method
Not applicable, as this is laboratory testing of a physical product against predefined physical and chemical specifications, not subjective interpretation by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI or imaging device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical product (nitrile examination gloves), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance of the Nitrile Examination Gloves is based on:
- Standard Specifications: Requirements outlined in established industry standards such as ASTM D6319, ASTM D5151, ASTM D6124, and ISO 10993-5, ISO 10993-10, ISO 10993-11. These standards define the acceptable physical dimensions, mechanical properties, freedom from holes, powder content, and biocompatibility profiles for such devices.
- Objective Measurements: Laboratory measurements and analyses conducted according to the specified test methodologies to determine if the device's properties fall within the defined acceptance criteria.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. The document describes pre-market non-clinical testing of a physical product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical device like examination gloves. The "ground truth" for the performance characteristics of the gloves (e.g., minimum tensile strength, maximum powder content) is established through regulatory standards and scientific consensus embodied in the ASTM and ISO documents.
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October 19, 2021
Niujian Technology Co., Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai, 200120 CHN
Re: K210706
Trade/Device Name: 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: September 6, 2021 Received: September 14, 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.
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
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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 (OS) 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
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Indications for Use
510(k) Number (if known) K210706
Device Name Nitrile Examination Gloves
Indications for Use (Describe)
The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
escription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K210706)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
Date Prepared: October 5, 2021
1.0 Submission Sponsor
| Manufacturer Name | Niujian Technology Co., Ltd. |
|---|---|
| Address | Room 401 Building 1, Anfangcheng No. 919, EastQunxian Road, Yuecheng District, Shaoxing, Zhejiang |
| Tel | 86-18210518920 |
| 385206015@qq.com | |
| Contact Person | Xiuqiang Zhou |
Designated Submission Correspondent
| Company Name | Shanghai Truthful Information Technology Co., Ltd |
|---|---|
| Address | Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120, China |
| Tel | +86-21-50313932 |
| Info@truthful.com.cn | |
| Contact Person: | Mr. Boyle Wang |
2.0 Device Identification
| Classification Name | Polymer Patient Examination |
|---|---|
| Glove Trade Name | Nitrile Examination Gloves |
| Device Classification | Class I |
| Regulation Number | 21 CFR 880.6250 |
| Panel | General Hospital |
| Product Code | LZA |
| Previous Submissions | None |
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I
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Panel: General Hospital
4.0 Predicate Device Information
Ever Growth (Vietnam) Co., Ltd. Sponsor: Device: Disposable Powder Free Nitrile Examination Glove, Pink Color Disposable Powder Free Nitrile Examination Glove, Black Color 510(k) number: K190942
5.0 Indication for Use
The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
6.0_Device Description
Nitrile Examination Gloves are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K210706) | Predicate Device(K190942) |
|---|---|---|
| Product Code | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | The Nitrile ExaminationGloves are non-steriledisposable device intendedfor medical purposes that areworn on the examiner'shands or finger to preventcontamination betweenpatient and examiner. | The Nitrile Powder Freepatient examination glove is anon-sterile disposable deviceintended for medical purposesthat is worn on the examiner'shands or finger to preventcontamination between patientand examiner. |
Table1-General Comparison
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| Material | Nitrile | Nitrile | |||
|---|---|---|---|---|---|
| Powdered orPowered free | Powdered free | Powdered free | |||
| Design Feature | Ambidextrous | Ambidextrous | |||
| Colorant | Blue | Blue | |||
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | |||
| Dimensions(mm) | Complies with ASTM D6319-19:Length: $\ge$ 230;Width:S: 80 $\pm$ 10;M: 95 $\pm$ 10;L: 110 $\pm$ 10;XL: 120 $\pm$ 10 | Complies with ASTM D6319-19:Length: $\ge$ 230;Width:XS:70 $\pm$ 10;S: 80 $\pm$ 10;M: 95 $\pm$ 10;L: 110 $\pm$ 10;XL: 120 $\pm$ 10 | |||
| Thickness(mm) | Complies with ASTM D6319-19:Finger: $\ge$ 0.05;Palm: $\ge$ 0.05 | Complies with ASTM D6319-19:Finger: $\ge$ 0.05;Palm: $\ge$ 0.05 | |||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min |
| UltimateElongation | 500% min | UltimateElongation | 500% min | ||
| AfterAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | |
| UltimateElongation | 400%min | UltimateElongation | 400%min | ||
| Freedom fromHoles | In accordance with ASTMD6319-19 and ASTM D5151-19, G-1, AQL 2.5 | In accordance with ASTMD6319-19 and ASTM D5151-19, G-1, AQL 2.5 | |||
| Powder Content | Complies with ASTM D6319-19:< 2mg per glove | Complies with ASTM D6319-19: < 2mg per glove | |||
| Biocompatibility | ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizerISO 10993-11;Under thecondition of acute | ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer/ |
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| systemic toxicity test,the test article did notshow acute systemictoxicity in vivo. | ||
|---|---|---|
| ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | ISO 10993-5Under conditions of the study,device extract is cytotoxic |
8.0 Summary of Non-clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
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.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | PhysicalDimensionsTest | Length(mm): $\geq$ 230;Width(mm):S: 80 $\pm$ 10;M: 95 $\pm$ 10;L: 110 $\pm$ 10;XL: 120 $\pm$ 10; | Length: $\geq$ 230;Width:S: 80-84M: 95-99L: 108-111XL: 117-121Pass |
| Thickness (mm):Finger: $\geq$ 0.05Palm: $\geq$ 0.05 | Finger: 0.08-0.10Palm: 0.06-0.08Pass | ||
| ASTM D5151 | WatertightnessTestforDetectionof | Meet the requirements ofASTM D5151 AQL 2.5 | 0/125 leaksPass |
Table 5 Summary of non-clinical performance testing
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| Holes | |||||
|---|---|---|---|---|---|
| ASTM D6124 | PowderContent | Meet the requirements ofASTM D6124 < 2.0mg | 0.02 mgPass | ||
| ASTM D6319ASTM D412 | Physicalproperties | BeforeAging | TensileStrength | $\geq14$ MPa | 26-35Pass |
| UltimateElongation | $\geq500$ % | 509-545Pass | |||
| AfterAging | TensileStrength | $\geq14$ MPa | 19-36Pass | ||
| UltimateElongation | $\geq400$ % | 447-510Pass | |||
| ISO 10993-5 | Cytotoxicity | cytotoxic | Under conditions of thestudy, show slightpotential toxicity to L-929 cells. | ||
| ISO 10993-11 | Acutesystemictoxicity test | Non- toxicity | Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.Pass | ||
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions ofthe study, not an irritant/Pass | ||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of thestudy, not a sensitizer./Pass |
9.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K190942.
§ 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.