(54 days)
The NITRILE EXAMINATION GLOVES 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 white, cobalt blue, black, blue. It can be available in six specifications: S, M, L, XL. The subject device is non-sterile.
This document is a 510(k) Premarket Notification for Nitrile Examination Gloves, a Class I medical device. The information provided is specifically for proving the substantial equivalence of these gloves to a legally marketed predicate device.
Therefore, the request for acceptance criteria and study details related to AI/ML-based medical devices using concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," "number of experts," "adjudication method," and "training set size and ground truth" are not applicable to this document.
This document describes the performance of the physical glove itself, not a software algorithm.
Here's a breakdown of the requested information based on the provided document, highlighting why most of the AI/ML-related questions are irrelevant:
1. A table of acceptance criteria and the reported device performance
The document provides this information clearly in "Table 2 - Summary of non-clinical performance testing" on pages 6-9.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):- S: ≥ 220- M/L/XL: ≥ 230Width (mm):- S: 80 ± 10- M: 95 ± 10- L: 110 ± 10- XL: 120 ± 10 | Length (mm):- S: ≥ 220- M/L/XL: ≥ 230.Width (mm):- White: S: 85-88/Pass, M: 96-98/Pass, L: 106-108/Pass, XL: 114-117/Pass- Cobalt Blue: S: 83-86/Pass, M: 95-99/Pass, L: 105-109/Pass, XL: 113-117/Pass- Black: S: 85-87/Pass, M: 95-98/Pass, L: 104-107/Pass, XL: 114-117/Pass- Blue: S: 84-86/Pass, M: 96-102/Pass, L: 104-107/Pass, XL: 114-116/PassThickness (mm):- Finger: White: 0.07-0.11/Pass, Cobalt Blue: 0.10-0.14/Pass, Black: 0.14-0.16/Pass, Blue: 0.09-0.11/Pass- Palm: White: 0.05-0.07/Pass, Cobalt Blue: 0.08-0.10/Pass, Black: 0.11-0.13/Pass, Blue: 0.07-0.08/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | White: 0.20-0.24mg/Pass; Cobalt Blue: 0.21-0.24mg/Pass; Black: 0.17-0.22mg/Pass; Blue: 0.16-0.19mg/Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Tensile Strength: White: 19-24MPa, Cobalt Blue: 19-26MPa, Black: 17-22MPa, Blue: 20-24MPaUltimate Elongation: White: 500-528%, Cobalt Blue: 517-633%, Black: 527-642%, Blue: 501-598% |
| ASTM D412 | Physical properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | Tensile Strength: White: 14-22MPa, Cobalt Blue: 18-24MPa, Black: 14-20MPa, Blue: 15-23MPaUltimate Elongation: White: 400-488%, Cobalt Blue: 489-578%, Black: 500-598%, Blue: 471-561% |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is not cytotoxic / Pass |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity in vivo | 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 |
Regarding the AI/ML-specific questions (2-9):
These questions are designed for evaluating AI/ML-based medical devices or diagnostic software. This 510(k) submission is for a physical device (nitrile examination gloves) and does not involve AI/ML technology, image analysis, computer vision, or diagnostic algorithms. Therefore, the concepts of "test set," "training set," "experts creating ground truth," "adjudication," or "human-in-the-loop performance" are not applicable.
The "study" referenced in this document refers to non-clinical performance testing of the physical glove's properties and biocompatibility, as outlined in the tables above.
Here's why each specific AI/ML question is not applicable:
- Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model. The "samples" are physical gloves subjected to laboratory tests. The provenance is likely from the manufacturing facility (Vietnam, as per submitter info).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for physical properties (e.g., tensile strength, dimensions) is established by standardized testing methods (e.g., ASTM, ISO) and laboratory equipment, not by human experts interpreting data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to human consensus on complex interpretations, not objective physical measurements.
- 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 for AI-assisted diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for glove performance is defined by the acceptance criteria of the relevant ASTM and ISO standards for physical properties and biocompatibility (e.g., a specific tensile strength value, AQL for holes, non-cytotoxicity as per ISO 10993-5).
- The sample size for the training set: Not applicable. There is no "training set" as this is not a learning algorithm.
- How the ground truth for the training set was established: Not applicable.
In conclusion, this 510(k) submission successfully demonstrates that the Nitrile Examination Gloves meet the required performance standards for their intended use through standard physical and biocompatibility testing, proving substantial equivalence to the predicate device. The framework of questions provided is not suitable for this type of medical device submission.
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April 2, 2022
NB Medical Co., LTD % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K220343
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: January 27, 2022 Received: February 7, 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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220343
Device Name NITRILE EXAMINATION GLOVES
Indications for Use (Describe)
The NITRILE EXAMINATION GLOVES 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
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
NB Medical Co., LTD Name: Address: Tay An Industrial Cluster, Tien Hai Town Tien Hai district, Thai Binh Province, Vietnam Phone Number: 86-13615395959 Contact: Kecheng Zhou Date of Preparation: Jan.30, 2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: NITRILE EXAMINATION GLOVES Common name: Patient Examination Gloves Classification Name: Non-powdered patient examination glove Model(s): S, M, L, XL (White/Cobalt Blue/Black/Blue)
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I General Hospital Panel:
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
5.0 Indication for Use
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The NITRILE EXAMINATION GLOVES 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 white, cobalt blue, black, blue. It can be available in six specifications: S, M, L, XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicated Device(K171422) | Comparison |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The NITRILE EXAMINATIONGLOVES is a non-steriledisposable deviceintended for medicalpurposes that is worn onthe examiner's hands orfinger to preventcontamination betweenpatient and examiner. | The Nitrile Powder Freepatient examinationglove is a non-steriledisposable deviceintended for medicalpurposes that is worn onthe examiner's hands orfinger to preventcontamination betweenpatient and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | White/Cobalt Blue/Black/Blue | White/Blue/ Black/ Pink | DifferentAnalysis 1 |
| LabelingInformation | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile | Same |
| Dimensions(mm) | Length:S: ≥220;M/L/XL: ≥230;Width: | Length:XS/S/M/L/XL: ≥230;Width:XS: 87+5; | DifferentAnalysis 2 |
Table 1-General Comparison
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| S: 80±10; | S: 85±5; | |||||
|---|---|---|---|---|---|---|
| M: 95±10; | M: 95±5; | |||||
| L: 110±10; | L: 105±5; | |||||
| XL: 120±10. | XL: 115±5 | |||||
| Thickness(mm) | Finger: ≥0.05;Palm: ≥0.05 | Finger: ≥0.05;Palm: ≥0.05 | Same | |||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa,min | TensileStrength | 14MPa,min | Same |
| UltimateElongation | 500% min | UltimateElongation | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa,min | TensileStrength | 14MPa,min | Same | |
| UltimateElongation | 400%min | UltimateElongation | 400%min | Same | ||
| Freedom fromHoles | Be free from holes whentested in accordancewith ASTMD5151AQL=2.5 | Be free from holes whentested in accordancewith ASTMD5151AQL=2.5 | Same | |||
| Powder Content | Meet the requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | Same | |||
| Biocompatibility | ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | N.A. | / | |||
| ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizer | ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizer | Same | ||||
| ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo. | N.A. | / |
Analysis 1: The subject device (White/Cobalt Blue/Black/Blue) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.
8.0 Summary of Non-clinical Testing
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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 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
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.
| TestMethod | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTMD6319 | PhysicalDimensionsTest | Length(mm):S: $\geq$ 220;M/L/XL: $\geq$ 230;Width(mm):S: 80 $\pm$ 10;M: 95 $\pm$ 10;L: 110 $\pm$ 10;XL: 120 $\pm$ 10. | Length(mm):S: $\geq$ 220;M/L/XL: $\geq$ 230.Width(mm):White:S: 85-88/PassM: 96-98/PassL: 106-108/ PassXL:114-117/ PassCobalt Blue:S: 83-86/PassM: 95-99/ PassL: 105-109/ PassXL:113-117/ PassBlack:S: 85-87/PassM: 95-98/ PassL: 104-107/Pass |
| ASTMD5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151AQL 2.5 | XL:114-117/ PassBlue:S: 84-86/PassM: 96-102/ PassL: 104-107/ PassXL:114-116/ Pass0/125/Pass |
| Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Thickness (mm):Finger:White:0.07-0.11/PassCobalt Blue:0.10-0.14/PassBlack:0.14-0.16/PassBlue:0.09-0.11/Pass | ||
| Palm:White:0.05-0.07/PassCobalt Blue:0.08-0.10/PassBlack:0.11-0.13/PassBlue:0.07-0.08/Pass | |||
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 <2.0mg | White:0.20-0.24mg/Pass;Cobalt Blue:0.21-0.24mg/Pass;Black:0.17-0.22mg/Pass;Blue:0.16-0.19mg/Pass |
Table 2 - Summary of non-clinical performance testing
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| ASTMD412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | White:19-24MPaCobalt Blue:19-26MPaBlack:17-22MPaBlue:20-24MPa |
|---|---|---|---|---|---|
| UltimateElongation | ≥500% | White:500-528%Cobalt Blue:517-633%Black:527-642%Blue:501-598% | |||
| AfterAging | TensileStrength | ≥14MPa | White:14-22MPaCobalt Blue:18-24MPaBlack:14-20MPaBlue:15-23MPa | ||
| UltimateElongation | ≥400% | White:400-488%Cobalt Blue:489-578%Black:500-598%Blue:471-561% | |||
| ISO10993-5 | Cytotoxicity | toxicity | |||
| ISO | Acute Systemic | Non- acute systemic |
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| 10993-11 | toxicity | the study, did notshow acute systemictoxicity in vivo / Pass | |
|---|---|---|---|
| ISO10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant/ Pass |
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer./ 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 NITRILE EXAMINATION GLOVES is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K171422.
§ 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.