(108 days)
Nitrile disposable examination gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.
This document describes the performance testing and acceptance criteria for Nitrile disposable examination gloves. It is important to note that this is a physical medical device (gloves), not an AI/software-based medical device. Therefore, many of the requested criteria in your prompt (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable to this type of device.
Here's the information extracted from the provided text, focusing on the relevant criteria for a physical device:
1. Table of Acceptance Criteria and Reported Device Performance
The performance data is primarily presented in a comparative table against ASTM standards.
| Test Methodology (Standard) | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions | Length: ≥220 mm (S), ≥230 mm (M, L, XL) | Pass |
| Width: S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | Pass | ||
| Thickness Finger: ≥0.05 mm | Pass | ||
| Thickness Palm: ≥0.05 mm | Pass | ||
| ASTM D6319-19 | Physical Properties | Before Aging: Tensile ≥14 Mpa; Elongation ≥ 500% | Pass |
| After Aging: Tensile ≥14 Mpa; Elongation ≥ 400% | Pass | ||
| ASTM D6319-19 (in acc. with ASTM D5151-19) | Watertightness Test for detection of holes | Batch size=35000, sample 125, ≤ 7 defects (AQL 2.5) | Pass |
| ASTM D6319-19 (in acc. with D6124-06(2017)) | Powder Residual | ≤ 2 (mg/glove) | Pass |
| ISO 10993-10: 2010 | Biocompatibility (Skin Irritation Test) | Non-irritation | Passes (non-irritation) |
| ISO 10993-10: 2010 | Biocompatibility (Skin Sensitization Test) | Non-sensitization | Passes (non-sensitization) |
| ISO 10993-11: 2017 | Biocompatibility (Acute Systemic Toxicity Test) | Non-acute systemic toxicity | Passes (non-acute systemic toxicity) |
| ASTM D7161-16 | Shelf Life | Determined a 3-year shelf life. (Specific numerical acceptance criteria not explicitly stated, but the 'Different*1 analysis' implies successful determination) | 3 years (Determined) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the Watertightness Test (detection of holes), the sample size is explicitly stated: 125 samples for a batch size of 35,000.
- For other tests (Physical Dimensions, Physical Properties, Powder Residual, Biocompatibility), specific sample sizes are not detailed in the provided document. The document refers to meeting ASTM and ISO standards, which would implicitly define testing sample sizes.
- Data Provenance: The tests are described as "bench testing" and "non-clinical performance data." The company performing the tests is XINGYU MEDICAL TECH CO.,LTD., located in China. The data is retrospective in the context of the 510(k) submission, meaning the tests were completed prior to submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device, and performance is measured against established international standards (ASTM, ISO) for physical and chemical properties, not by human expert interpretation of data or images. The "ground truth" is defined by the technical specifications and test methodologies within these standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device, testing is quantitative and follows specific, standardized protocols. There is no human adjudication process involved in the interpretation of physical test results. Results are either "Pass" or "Fail" based on whether they meet the numerical acceptance criteria of the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. This is a physical medical device (gloves), so an MRMC study is not applicable. The document explicitly states: "Clinical data is not needed to demonstrate the performance or safety of the subject glove as compared to the predicate device or applicable standards."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to AI algorithm performance. This product is a physical glove, not an algorithm. The testing described is "standalone" in the sense that it's testing the inherent properties of the glove itself against defined standards.
7. The Type of Ground Truth Used
- The ground truth for this device's performance relies on established international consensus standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06(2017), ISO 10993-10: 2010, ISO 10993-11: 2017, ASTM D7161-16). These standards define the acceptable physical dimensions, mechanical properties (tensile strength, elongation), barrier integrity (pinholes), chemical properties (powder residual), and biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. This refers to AI algorithm training data. This product is a physical glove and does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for a physical device like this, there is no ground truth established in this context.
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December 2, 2021
Xingyu Medical Tech Co., Ltd. Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 China
Re: K212578
Trade/Device Name: Nitrile disposable examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 24, 2021 Received: November 3, 2021
Dear Eva Li:
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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542 of the Act); 21 CFR 1000-1050.
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-
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.
Ligun Zr
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) K212578
Device Name Nitrile disposable examination gloves
Indications for Use (Describe)
Nitrile disposable examination gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand 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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K212578(Page1 / 5)
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
510 (K) Summary
The assigned 510(k) number is: K212578
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | XINGYU MEDICAL TECH CO.,LTD. |
|---|---|
| Submitter's Address : | NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, |
| WEIFANG CITY, SHANDONG PROVINCE, CHINA | |
| Phone number : | 0086-18263618867 |
| Contact person: | Cathrine Luan |
| Email: | cathrine@xingyugloves.com |
Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com
Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
Date of Preparation: 2021-11-23
2.0 Name of the Device
Proprietary/Trade name: Nitrile disposable examination gloves Model(s):
| Model | Color | Size |
|---|---|---|
| D5000 | Blue | S, M, L, XL |
| D6000 | Black | S, M, L, XL |
| D7000 | White | S, M, L, XL |
| D8000 | Purple | S, M, L, XL |
| Common Name: | Exam gloves |
| Common Name: | Exam gloves |
|---|---|
| Classification Name: | Patient examination glove |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
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NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
3.0 Predicate Device
| Device Name: | Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color |
|---|---|
| Company name: | Shandong Xingyu Gloves Co.,Ltd. |
| 510(K) Number: | K171616 |
4.0 Device Description:
How the device functions:
Nitrile films form a barrier to prevent contamination between patient and examiner. Scientific concepts that form the basis for the device:
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
Physical and performance characteristics such as design, materials and physical properties: The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.
5.0 Device Indication for use:
Nitrile disposable examination gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
| Features &Description | Predicate Device | Proposed Device | Result ofComparison |
|---|---|---|---|
| Company | Shandong Xingyu GlovesCo.,Ltd | XINGYU MEDICAL TECHCO.,LTD. | – |
| 510(K) Number | K171616 | K212578 | – |
| Product name | Xingyu Powder Free NitrilePatient Examination Gloves,Blue | Nitrile disposableexamination gloves | – |
| Product Code | LZA | LZA | Same |
| Size | Small/ Medium/ Large/X large | Small/Medium/Large/X large | Same |
| Indications for Use | Powder Free Nitrile PatientExamination Gloves, BlueColor is a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer. | Nitrile disposableexamination gloves are non-sterile disposable deviceintended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer. | Same |
6.0 Summary of the Technological Characteristics of the Device:
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K212578(Page3 / 5)
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
| Device Descriptionand Specifications | Meets ASTM D6319-10(Reapproved 2015) | Meets ASTM D6319-19 | same |
|---|---|---|---|
| DimensionsLengthILS-2 AQL4.0 | 232 mm min for all sizes | 230 mm min for all size | Similar*1 |
| Dimensions --WidthIL S-2 AQL4.0 | S: 76-88 mmM: 89-102 mmL: 108-119mmXL: 115-128 mm | S: 83-89 mmM: 88-100 mmL: 103-111 mmXL: 114-119 mm | Similar*1 |
| Dimensions --Thickness IL S-2AQL4.0 | Thickness (mm) min. Finger0.08Palm 0.08 | Thickness (mm) min. Finger0.09Palm 0.05 | Similar*1 |
| Physical PropertiesIL S- 2 AQL4.0 | AgingElongation (%)TensileStrength(MPa) | AgingElongation (%)TensileStrength(MPa) | Similar*2 |
| Before After530- 460-600 58018-25 17-22 | Before After≥500% ≥400%≥14 ≥14 | ||
| Freedom fromPinholesInspection Level IAQL2.5 | Meets• 21 CFR 800.20• ASTM D6319-10 (Reapproved2015) Tested in accordancewith ASTM D5151(Reapproved 2015)with acceptable results | Meets•ASTM D 6319-19 Tested inaccordance with ASTMD5151-19 with acceptableresults | same |
| Residual Powder | Meets ASTM D 6124-06(Reaffirmation 2011)Results generated valuesbelow 2mg of residualpowder | Meets ASTM D 6124-06 (2017)Results generated valuesbelow 2mg of residualpowder | same |
| Materials used tofabricate the devices | Nitrile | Nitrile | same |
| Shelf life | NA | 3 years | Different*1 |
| Compare datasupporting DevicePerformance | Meets ASTM D5151-06(Reapproved 2015) ASTMD6319-10 (Reapproved 2015)ASTM D6124-06(Reaffirmation 2011) | Meets ASTM D5151-19 ASTM D6319-19ASTM D6124-06(2017) | same |
| Single Patient Use | Single Patient Use | Single Patient Use | same |
| Biocompatibility | Under the conditions of thisstudy, the test article was anon-irritant or non-sensitizer.Meets ISO 10993-10:2010 | Under the conditions of thisstudy, the test article was a non-irritant, non- sensitizer and doesnot pose acute systemic toxicity.Meets ISO 10993-10:2010.Meets ISO 10993-11:2017 | Similar*3 |
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K212578(Page4 / 5)
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
Similar*1 analysis :
The Dimensions (length, width and fingers thickness) of the proposed deice is not same with the predicate device, however the Dimensions of the subject device all meet the criteria of the ASTM D6319-19. The test results show the differences do not affect compliance with the associated standards for the proposed device.
Similar*2 analysis :
Physical Properties of the proposed deice is not same with the predicate device, however the Physical Properties meet the criteria of the ASTM D6319-19. The test results show the differences do not affect compliance with the associated standards for the proposed device.
Similar*3 analysis :
Compare the predicate device, except the Skin Irritation Test and Skin sensitization test, the proposed device conduct the Acute Systemic Toxicity Test meets ISO 10993-11: 2017 additional and show it non-acute systemic toxicity. The biocompatibility test results show the differences do not affect compliance with the associated standards for the proposed device.
Different*1 analysis :
The proposed device determined with a 3 year shelf life. This shelf life determination was conducted under experiment per ASTM D7161-16. The observed differences do not affect compliance with the associated standards for the proposed device.
7.0 Assessment of Non-Clinical Performance Data:
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate conformance with the applicable standards. The non-clinical performance testing completed for the XINGYU MEDICAL TECH CO.,LTD. nitrile disposable examination gloves demonstrated that the subject device met the acceptance criteria or specification for the applicable test methodology or standard as shown below.
- . Dimension per ASTM D6319-19
- . Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-19
- Water leak test on pinhole per ASTM D6319-19/D6124-06 (2017)
- Powder Residual tests per ASTM D6319-19
- . Biocompatibility tests per ISO 10993-10: 2010 and ISO 10993-11: 2017
Performance of the nitrile disposable examination gloves are tested with the following technological characteristics as compared to ASTM or equivalent standards.
| Testmethodology | Purpose | Acceptance criteria | Result | ||||
|---|---|---|---|---|---|---|---|
| S | M | L | XL | ||||
| ASTM D6319-19 | PhysicalDimensions | Length ( mm ) | ≥220 | ≥230 | pass | ||
| Width ( mm ) ±10 | 80±10 | 95±10 | 110±10 | 120±10 | pass | ||
| Thickness Finger | ≥0.05 mm | pass | |||||
| Palm | ≥0.05 mm | pass | |||||
| ASTM D6319-19 | Physicalproperties | Before Aging | Tensile≥14Mpa; Elongation ≥ 500% | pass | |||
| After Aging | Tensile≥14Mpa; Elongation ≥ 400% | pass |
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K212578(Page5 / 5)
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
| CHINA | |
|---|---|
| -- | ------- |
| ASTM D6319-19Test method inaccordance withASTM D5151-19 | Watertightness Testfordetectionof holes | Batch size=35000, sample 125$≤$ 7 | pass |
|---|---|---|---|
| ASTM standardD 6319-19Test method inaccordance withD6124-06(2017) | PowderResidual | $≤$ 2 (mg/glove) | pass |
| Purpose | Standard | Acceptancecriteria | Result |
|---|---|---|---|
| Biocompatibility | Skin Irritation Test ExtractionMethod ISO 10993-10: 2010 | non-irritation | PassesUnder the conditions ofthe study, the subjectdevice is non-irritation |
| Biocompatibility | Skin sensitization the guineapig maximization ISO 10993-10: 2010 | non- sensitization | PassesUnder the conditions ofthe study, the subjectdevice is non-sensitization |
| Biocompatibility | Acute Systemic ToxicityTest ISO 10993-11: 2017 | non- acute systemictoxicity | PassesUnder the conditions ofthe study, the subjectdevice is non-acutesystemic toxicity |
8.0 Assessment of Clinical Performance Data:
Clinical data is not needed to demonstrate the performance or safety of the subject glove as compared to the predicate device or applicable standards.
9.0 Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K212578, the Nitrile disposable examination gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K171616.
§ 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.