(100 days)
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (7"), medium (8"), large (8.5"), X-large (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
This is a 510(k) premarket notification for nitrile examination gloves, not an AI/ML medical device. Therefore, the request for acceptance criteria and study details related to AI/ML performance metrics (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable.
The document assesses the substantial equivalence of the proposed device (Nitrile Examination Gloves) to a predicate device (Powder Free Nitrile Patient Examination Gloves, Blue Color) based on non-clinical testing and comparison of technological characteristics.
Here’s a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of the proposed device with a predicate device, referencing ASTM standards for acceptance criteria. The performance of the proposed device is stated as meeting these requirements.
| Item | Acceptance Criteria (typically from ASTM D6319-19) | Reported Device Performance (K203593) |
|---|---|---|
| Freedom from holes | Meets requirements of ASTM D6319-19 | Meets requirements of ASTM D6319-19 |
| Physical Properties (before aging) | Meets requirements of ASTM D6319-19 | Meets requirements of ASTM D6319-19: Tensile Strength: ≥14 MPa, Elongation: ≥500% |
| Physical Properties (after aging) | Meets requirements of ASTM D6319-19 | Meets requirements of ASTM D6319-19 |
| Powder residual | < 2.0 mg/gloves | < 2.0 mg/gloves |
| Biocompatibility - Skin Sensitization Test | "Not a sensitizer" under test conditions | Under the test condition of study not a sensitizer |
| Biocompatibility - Skin Irritation Test | "Not an irritant" under test conditions | Under the test condition of study not an irritant |
| Biocompatibility - Cytotoxicity Test | (Predicate: Non-cytotoxic to L-929 cells) | Cytotoxicity is assessed via rationale. Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. |
Note: The table above extracts information primarily from the "Comparison of technological characteristics with the predicate devices" section and the "Non-Clinical Testing" section.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a medical glove submission and not an AI/ML device. The "test set" in this context refers to the samples of gloves tested according to the specified ASTM and ISO standards, not a data set for an algorithm. The document doesn't detail the sample sizes for each physical or biocompatibility test, but it indicates adherence to the standards. The manufacturing country of origin is China (Guang Dong Kingfa SCI. & TECH.CO., LTD.).
3. 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)
This is not applicable. "Ground truth" in the AI/ML sense is not relevant here. The "ground truth" for glove performance is established by the defined ASTM and ISO standards, and testing is performed by laboratories that adhere to these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically associated with resolving discrepancies in expert interpretations of medical images or data. Standardized laboratory testing methods do not involve such adjudication processes.
5. 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
This is not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the gloves is based on established industry standards (ASTM D6319-19, ASTM D3767-03(2020), ASTM D5151-19, ASTM D6124-06(2017), ASTM D573-04(2019), ASTM D412-16, ISO 10993-10: 2010, ISO 10993-11:2017). These standards define the acceptable physical properties and biocompatibility characteristics for medical examination gloves.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML 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 logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 19, 2021
Guang Dong Kingfa SCI. & TECH.CO., LTD. % Shelley Li Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555. Jingan Shanghai, 200071 China
Re: K203593
Trade/Device Name: Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 6, 2021 Received: February 16, 2021
Dear Shelley 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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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.
Ryan Ortega Ph D. 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) Unknown
Device Name Nitrile examination gloves
Indications for Use (Describe)
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
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: K203593
I. Submitter
GUANG DONG KINGFA SCI. & TECH.CO., LTD. No.28 Delong Ave., Shijiao Town, Qingcheng District, Qing yuan, Guangdong, China
Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn
Preparation date: Mar. 18, 2021
US Agent
Jeff Zhang Ucl-Reg Service Inc 602 Rockwood Rd Wilmington, DE US 19802 Phone: 516 2311209 Email: us-agent@glomed-info.com
II. Proposed Device
| Device Trade Name | Nitrile examination gloves |
|---|---|
| Common name: | Polymer Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K181106 |
|---|---|
| Trade name: | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Common name: | Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer: | JiangSu Dongxin Medical Technology Co., Ltd. |
IV. Device description
The propose devices is powder free nitrile examination gloves, provided as non-sterile
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and disposable device. The proposed devices are blue color and there are four sizes, includes small (7"), medium (8"), large (8.5"), X-large (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
V. Indication for use
The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device(K203593) | Predicate device(K181106) | Discussion |
|---|---|---|---|
| Product name | Nitrile ExaminationGloves | Powder Free NitrilePatient ExaminationGloves, Blue Color | - |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication foruse | The nitrileexamination glove isintended to be wornon the hands ofexaminers to preventcontaminationbetween patient andexaminer. This is asingle-use,powder-free,non-sterile device. | Powder Free NitrilePatient ExaminationGloves, Blue Color isa non-steriledisposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger topreventcontaminationbetween patient andexaminer. | Same |
| Main Material | Nitrile rubber | Nitrile rubber | Same |
| Color | Blue | Blue | Similar* |
| Table 1 Comparison of Natural Rubber Surqical Gloves | ||
|---|---|---|
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| Size | Small, Medium,Large, X large | Small, Medium,Large, X large | Same |
|---|---|---|---|
| Palm width | Small (80±10mm)Medium (95±10mm)Large (110±10mm)X large (120±10mm) | Small (76-90mm)Medium (89-102mm)Large (108-119mm)X large (115-128mm) | SimilarMinor differenceof palm widthdoes not affectthe intendeduse |
| Length | S (220mm min)M (230mm min)L (230mm min)XL (230mm min) | 232 mm min for allsize | SimilarThe length ofthe subjectdevice isshorter than thepredicate's |
| Thickness | Palm: 0.05mm minFinger: 0.05mm min | Palm: 0.08mmFinger tip: 0.08mm | SimilarThe thicknessof the subjectdevice isthinner than thepredicates |
| Freedom fromholes | Meets requirementsof the ASTM D6319-19 | Meets requirementsof the ASTM D6319-10 | SimilarOnly thedifferentstandardversion. Thisrequirementgiven in thestandard is thesame. |
| PhysicalProperties(before aging) | Meets requirementsof the ASTM D6319-19Tensile Strength:≥14 MPaElongation:≥500% | Meets requirementsof the ASTMD6319-10Tensile Strength:≥14 MPaElongation:≥500% | SimilarOnly thedifferentstandardversion. Therequirements ofphysicalproperties givenin the standardare the same. |
| PhysicalProperties(after aging) | Meetsrequirementsof the ASTM D6319-19 | Meets requirementsof the ASTMD6319-10 | SimilarOnly thedifferentstandardversion. Therequirements ofphysicalproperties givenin the standardare the same. |
| Powderresidual | <2.0 mg/gloves | <2.0 mg/gloves | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Shelf-life | 3 years | Unknown | The shelf-lifetesting wasperformed thatdemonstratemeet theclaimedshelf-life. |
| Biocompatibility- SkinSensitizationTest | Under the testcondition of study nota sensitizer | Under the testcondition of study nota sensitizer | Same |
| Biocompatibility- Skin IrritationTest | Under the testcondition of study notan irritant | Under the testcondition of study notan irritant | Same |
| Biocompatibility- CytotoxicityTest | Cytotoxicity isassessed viarationale. Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo. | Under the testconditions, the testarticle was non-cytotoxic to L-929cells. | Different |
| Tensile Strength:$\geq$ 14 MPaElongation:$\geq$ 400% | Tensile Strength:$\geq$ 14 MPaElongation:$\geq$ 400% |
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*As above comparison, the difference in the dimensions and reference standard version of the subject and predicate device does not raise additional questions for
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safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results pass the requirements.
VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for . Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions .
- ASTM D5151-19, Test Method for Detection of Holes in Medical Gloves .
- . ASTM D6124-06(2017), Test Method for Residual Powder on Medical Gloves
- ASTM D573-04(2019), Test Method for Rubber-Deterioration in anAir Oven .
- ASTM D412-16, Test Methods for Vulcanized Rubber andThermoplastic . Elastomers-Tension
- 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
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K203593, the Nitrile Patient Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K181106.
§ 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.