(219 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a 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.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is non-sterile and disposable medical glove intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of nitrile butadiene rubber (NBR), as per standard meets ASTM D6319-10(Reapproved 2015).
The proposed device is Powder Free Nitrile Examination and variants of different sizes, such as size S/M/L/XL. All variants share the same color, blue.
The provided text describes the 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color" (K211864). This document primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device. It specifically states that "Clinical testing is not needed for this device." Therefore, the requested information pertaining to AI/ML device studies, such as multi-reader multi-case studies, expert adjudication, training/test set ground truth establishment, or sample sizes for AI model development, is not applicable to this submission.
The document outlines the acceptance criteria and reported device performance based on non-clinical tests.
Here is the table summarizing the acceptance criteria and stated performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension Length | ≥ 230mm | 237 mm min for all sizes | Pass |
| Dimension Width | Small 70-90 mm | 85-87 mm | Pass | |
| Medium 85-105mm | 95-97 mm | Pass | ||
| Large 100-120mm | 105-107mm | Pass | ||
| X large 110-130 mm (from comparison table) | 115-117 mm (from comparison table) | Pass | ||
| Thickness | Fingertip ≥ 0.05 mm | 0.091mm | Pass | |
| Palm ≥ 0.05 mm | 0.072mm | Pass | ||
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties: Tensile strength (Before & After aging) | ≥14MPa | 16.5-19.3 MPa | Pass |
| Physical Properties: Before aging Elongation | ≥500% | 526-560% | Pass | |
| Physical Properties: After aging Elongation | ≥400% | 432-492% | Pass | |
| • 21 CFR 800.20, • ASTM D 6319-06 (Reapproved 2015), • ASTM D5151-19 | Freedom from pinholes: Water leakage test | Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11. | 2 noncompliance is allowed. | Pass |
| • ASTM D6319-10 (Reappr oved 2015), • ASTM D6124-06 (Reapproved 2017) | Powder Residual | <2mg/glove | Mean: 0.6-0.9 mg/pcs | Pass |
| Primary Skin Irritation in rabbits ISO 10993-10: 2010-08-01 | Biocompatibility | Under the conditions of the study, the subject device is not a primary skin irritant. | Passes | Pass |
| Dermal sensitization in the guinea pig ISO 10993-10: 2010-08-01 | Biocompatibility | Under the conditions of the study, the subject device is not a skin sensitizer. | Passes | Pass |
| The test article was added to L929 cells measured by MTT assay ISO 10993-5: 2009 | Biocompatibility | Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells. | Cytotoxic. Additional testing performed to determine if this was a systemic toxicity concern. | See Note below |
| Acute Systemic Toxicity Systemic injection in mice ISO 10993-11: 2017 | Biocompatibility | Under the conditions of study the device extracts do not pose a systemic toxicity concern. | Pass | Pass |
Note on Biocompatibility (Cytotoxicity): The device was found to be "cytotoxic" in the initial ISO 10993-5 test. However, the subsequent Acute Systemic Toxicity test (ISO 10993-11) passed, indicating that despite the in-vitro cytotoxicity, the device extracts do not pose a systemic toxicity concern in vivo. The document explicitly states: "Under the conditions of this study, the test article was shown potential toxicity to L-929 cells," but then for Acute Systemic Toxicity, it states, "Under the conditions of study, the device extracts do not pose a systemic toxicity concern (ISO 10993-11:2017)." This implies that the initial cytotoxicity finding was addressed and deemed not to be a safety concern in the context of systemic exposure.
Regarding the other requested information (2-9), as a 510(k) for a Class I medical device (patient examination gloves) that explicitly states "Clinical testing is not needed for this device," the following items are not applicable or not detailed in this submission because they are typically relevant for AI/ML-driven or image-analysis medical devices, which these gloves are not:
- Sample size used for the test set and the data provenance: Not applicable. These are physical product tests, not data-driven AI model tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (like glove dimensions, tensile strength, pinholes) is established by adherence to specified ASTM and ISO testing standards, not by expert consensus readings of images or data.
- Adjudication method for the test set: Not applicable.
- 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-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for these tests is defined by established international standards (ASTM, ISO) for physical and chemical properties of gloves.
- The sample size for the training set: Not applicable. There is no AI model involved.
- How the ground truth for the training set was established: Not applicable.
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January 21, 2022
Siyang Jaysun Medtech Co., Ltd. % Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang,Chaoyang District Beijing, 100121 China
Re: K211864
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 16, 2021 Received: December 20, 2021
Dear Chu Xiaoan:
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, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211864
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Color
Indications for Use (Describe)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a 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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510(K) Summary
K211864
This summary of 510(k) is being submitted in accordance with 21 CFR 807.
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Siyang Jaysun Medtech Co., Ltd. |
|---|---|
| Submitter's address : | No.26 Changjiang Rd, Siyang EconomicDevelopment Zone, Suqian City, JiangsuProvince,223700,China |
| Name of contact person: | Mr. Chen Fang |
| Contact phone number | 0086-0527- 85552002 |
| Date of preparation : | 2022-01-17 |
2.0 Name of the Device
| Proprietary/Trade name: | Powder Free Nitrile Patient ExaminationGloves, Blue Color |
|---|---|
| Common Name: | Patient Examination gloves |
| Classification Name: | Non-powdered Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
3.0 Predicate device
| Device Name: | Powder Free Nitrile Patient ExaminationGlove, Blue Color |
|---|---|
| Company name: | Tangshan Zhonghong Pulin Plastic Co., Ltd. |
| 510(K) Number: | K120970 |
4.0 Device Description:
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is non-sterile and disposable medical glove intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of nitrile butadiene rubber (NBR), as per standard meets ASTM D6319-10(Reapproved 2015).
The proposed device is Powder Free Nitrile Examination and variants of different sizes, such as size S/M/L/XL. All variants share the same color, blue.
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5.0 Indications for Use Statement:
Powder Free Nitrile Patient Examination Gloves, Blue Color is a 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 (K120970) | Subject Device (K211864) | Result of Comparison |
|---|---|---|---|
| Product name | Powder Free Nitrile Patient Examination Glove, Blue Color | Powder Free Nitrile Patient Examination Gloves, Blue Color | Same |
| Regulation Number | 21CFR880.6250 | 21CFR880.6250 | Same |
| Product Code | LZA | LZA | Same |
| Color | Blue | Blue | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same |
| Indications for Use | Powder Free Nitrile Patient Examination Glove, Blue Color 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. | Powder Free Nitrile Patient Examination Gloves, Blue Color 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. | Same |
| Dimensions --LengthInspection Level S-2AQL4.0 | Meets ASTM D6319-10≥230mm min | 237 mm min for all sizes | Similar |
| Dimensions -- WidthInspection Level S-2AQL4.0 | Meets ASTM D6319-10Small 70-90 mmMedium 85-105mmLarge 100-120mmX large 110-130 mm | Small 85-87mmMedium 95-97 mmLarge 105-107mmX large 115-117 mm | Similar |
| Dimensions --ThicknessInspection Level S-2AQL4.0 | Meets ASTM D6319-10Finger 0.05mm min.Palm 0.05mm min. | Thickness (mm) min.Finger 0.091Palm 0.072 | Similar |
| Physical PropertiesInspection Level S-2AQL4.0 | Meets ASTM D D6319-10Before aging/after agingTensile Strength≥ 14MPaBefore agingElongation ≥500%After agingElongation ≥400% | Aging Before AfterElongation (%) 526-560 432-492Tensile Strength (MPa) 17.5-19.3 16.5-18.5 | Similar |
| Freedom from PinholesInspection Level IAQL2.5 | Meets• 21 CFR 800.20• ASTM D6319-10 | 1) Inspection Level I AQL2.5,and Accept/Reject criteria of 10/112) Water leakage test: 2 noncompliance is allowed. | Similar |
| D 6124-06(Reaffirmation 2011) | sub-samples (N=5).2) Result as following:Mean: 0.6-0.9 mg/pcs | ||
| below 2mg of residualpowder | |||
| Materials used tofabricate the devices | Nitrile | Nitrile | Same |
| Single Use | Single Use | Single Use | Same |
| BiocompatibilityPrimary SkinIrritation-ISO10993-10:2010(E) | Under the conditionof study, not anirritant | Under the conditionof study, not anirritant | Same |
| BiocompatibilityDermalSensitization-ISO10993-10:2010(E) | Under the conditionsof the study, not asensitizer | Under the conditionsof the study, not a sensitizer. | Same |
| BiocompatibilityIn vitrocytotoxicityISO10993-5:2009(E) | N.A. | Under the conditions of thisstudy, the test article wasshown potential toxicity toL-929 cells | Different |
| BiocompatibilityAcute SystemicToxicity Systemicinjection in miceISO 10993-11:2017 | N.A. | Under the conditions ofstudy, the device extracts donot pose a systemic toxicityconcern (ISO10993-11:2017) | Different |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile | -Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile | Same |
Technological Characteristic Comparison: 6.0
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For all above differences (state "similar" in the right column on above table) between the subject and predicate devices, they are derived from both individual product differentiation and each items are within the range, complied with all requirements of the standards at the current time, so those differences are not critical to the intended use and the differences do not affect the safety and effectiveness of the subject device.
7.0 Discussion of Non-clinical and Performance 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:
| Test Method | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTM D 6319-06(Reapproved 2015). | Dimension | Length | $\geq$ 230mm | 237 mm min for all sizes |
| Width | Small 70-90 mm | 85-87 mm | ||
| Medium 85-105mm | 95-97 mm | |||
| Large 100-120mm | 105-107mm | |||
| Thickness | Fingertip $\geq$ 0.05 mm | 0.091mm |
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| Palm | 0.072mm | |||||
|---|---|---|---|---|---|---|
| ASTM D 6319-06(Reapproved 2015). | PhysicalProperties | Tensilestrength(Before &After aging) | ≥14MPa | 16.5-19.3 MPa | ||
| BeforeagingElongation | ≥500% | 526-560% | ||||
| After agingElongation | ≥400% | 432-492% | ||||
| •21 CFR 800.20• ASTM D 6319-06(Reapproved 2015).• ASTM D5151-19 | Freedomfrompinholes | Water leakage test:Inspection LevelI, AQL2.5, andAccept/Reject criteria of 10/11. | 2noncomplianceis allowed.Pass | |||
| • ASTMD6319-10(Reapproved 2015)• ASTM D6124-06(Reapproved2017), | PowderResidual | Meets<2mg/glove | Mean: 0.6-0.9mg/pcsPass | |||
| Primary SkinIrritation in rabbitsISO 10993-10:2010-08-01 | Biocompatibility | Under the conditions of the study, thesubject device is not a primary skinirritant. | Passes | |||
| Dermal sensitizationin the guinea pig ISO10993-10:2010-08-01 | Under the conditions of the study, thesubject device is not a skin sensitizer. | Passes | ||||
| The test article wasadded to L929 cellsmeasured by MTTassay ISO 10993-5:2009 | Under the conditions of this study, thetest article was non-cytotoxicity toL-929 cells. | Under the conditions of the study,cytotoxic.Additional testing wasperformed to determine if thiswas a systemic toxicity concern. | ||||
| Acute SystemicToxicity Systemicinjection in miceISO 10993-11:2017 | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Pass |
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
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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 D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.
8.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
9.0 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.