(82 days)
The Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
This document describes the premarket notification (510(k)) for Nitrile Examination Gloves submitted by Zhenjiang Huayang Latex Products Co., Ltd. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Remark |
|---|---|---|---|
| Physical Properties | |||
| Before Aging | |||
| Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 500% min | 500% min | Same |
| After Aging | |||
| Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 400%min | 400%min | Same |
| Overall Compliance | Comply with ASTM D6319 | Comply with ASTM D6319 | Same |
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same |
| Powder Content | Meet the requirements of ASTM D6124 | 0.02 mg per glove | Same |
| Biocompatibility | |||
| Irritation | Not an irritant | (Implicitly meets standard ISO 10993-10:2010) | Same |
| Sensitization | Not a sensitizer | (Implicitly meets standard ISO 10993-10:2010) | Same |
| Cytotoxicity | Device extract is not cytotoxic | (Implicitly meets standard ISO 10993-5:2009) | Same |
| Dimensions | |||
| Length (mm) | 230 min (for S, M, L, XL sizes) | 230 min (for S, M, L sizes) | Similar (although subject device only tested S, M, L) |
| Width (mm) | 75, 85, 95, 105, 115 ±5 (for XS, S, M, L, XL) | 80, 95, 110 ±10 (for S, M, L) | Similar (Physical dimensions are different but meet ASTM D6319-19 requirements) |
| Finger Thickness (mm) | 0.05 min | 0.05 min | Similar |
| Palm Thickness (mm) | 0.05 min | 0.05 min | Similar |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (physical properties, freedom from holes, powder content, and biocompatibility). The provenance of the data is retrospective, as it refers to testing conducted on the subject device to demonstrate substantial equivalence to a legally marketed predicate device. The country of origin of the device manufacturer is China (Zhenjiang Huayang Latex Products Co., Ltd. in Jiangsu Province, P.R.China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" here is established by standardized test methods (e.g., ASTM, ISO) performed in a laboratory setting, rather than through expert consensus in a medical imaging or diagnostic context.
4. Adjudication method for the test set
This information is not applicable to this type of device comparison. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution. For a medical glove, performance is evaluated against defined test standards.
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. An MRMC study is relevant for AI-assisted diagnostic tools. This device is a nitrile examination glove, which does not involve human readers or AI assistance in a diagnostic capacity.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This refers to the performance of an algorithm without human input, which is not relevant for a medical glove.
7. The type of ground truth used
The ground truth used for this device is based on standardized test methods and specifications (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5) and comparison to a legally marketed predicate device.
8. The sample size for the training set
This is not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is evaluated through physical and chemical testing.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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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 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.
April 7, 2021
Zhenjiang Huayang Latex Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K210106
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: December 25, 2020 Received: January 15, 2021
Dear Boyle Wang:
We have reviewed vour 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 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.
Clarence W. Murray III -S
Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health
Enclosure
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510(k) Summary K210106
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Zhenjiang Huayang Latex Products Co.,Ltd. Address: Lianhe Village,Xinba Town,Yangzhong City, Jiangsu Province, P.R.China 212212. Tell: +86- 511-88427686 Contact: Han Sheng Date of Preparation: Dec.25,2020
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng 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
3.0_Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
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
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5.0 Indication for Use
The Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
6.0_Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicated Device(K171422) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | Same | ||
| Intended Use | The NitrileExaminationGloves is adisposable deviceintended formedical purposesthat is worn on theexaminer's handsto preventcontaminationbetween patientand examiner. | The DisposablePowder Free NitrileExamination Glove,White/ Blue/ Black/Pink Color is adisposable deviceintended formedical purposesthat is worn on theexaminer's handsto preventcontaminationbetween patientand examiner. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-useindication, powderfree, device color,device name,glove size andquantity, NitrileGlove Powder | Single-useindication, powderfree, device color,device name, glovesize and quantity,Disposable PowderFree Nitrile | Same |
Table 1-General Comparison
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| Free Blue, Non-Sterile | Examination Glove,Non-Sterile | |
|---|---|---|
| ---------------------------- | ----------------------------------- | -- |
| Size | |||||||
|---|---|---|---|---|---|---|---|
| Designation | XS | S | M | L | XL | Tolerance | |
| PredicateDevice(K171422) | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Designation | Size | Tolerance | |||||
| Subject Device | S | M | L | ||||
| Length, mm | 230 | 230 | 230 | min | |||
| Width, mm | 80 | 95 | 110 | ±10 | |||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | SIMILAR |
Table2 Device Dimensions Comparison
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19.
Table3 Performance Comparison
| Item | Subject device | Predicated device (K171422) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | White/ Blue/ Black/ Pink | Same | ||
| PhysicalProperties | BeforeAging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 500% min | 500% min | Same | ||
| AfterAging | Tensile Strength | 14MPa, min | 14MPa, min | Same | |
| Ultimate Elongation | 400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply with ASTM D6319 | Same | |||
| Freedom from Holes | Be free from holes when tested in | Be free from holes when tested in | Same |
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| accordancewithASTMD5151AQL=2.5 | accordancewithASTMD5151AQL=2.5 | ||
|---|---|---|---|
| Powder Content | 0.02 mg perglove | Meet therequirementsof ASTMD6124 | Same |
Table4 Safety Comparison
| Item | Subjectdevice | Predicateddevice(K171422) | Remark |
|---|---|---|---|
| Material | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Under theconditions ofthe study, notan irritant | Same |
| Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Underconditions ofthe study, nota sensitizer. | ||
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn VitroCytotoxicity) | Underconditions ofthe study,deviceextract is notcytotoxic | / |
8.0 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
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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.
9.0 Discussion of Clinical and Performance 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.
§ 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.