(79 days)
The Blue Nitrile Exam Glove, Powder Free 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 blue. The subject device is non-sterile.
The provided text describes a 510(k) summary for a medical device called "Blue Nitrile Exam Glove, Powder Free" (K210057). This document focuses on demonstrating substantial equivalence to a predicate device (K171422) rather than conducting a standalone study to prove acceptance criteria for a novel device. Therefore, many of the requested categories related to a detailed study on performance, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, and ground truth for training sets, are not applicable in this context.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM and ISO standards for examination gloves. The "reported device performance" is essentially the statement that the device complies with these standards and the listed physical property values.
| Item | Acceptance Criteria (Standard / Predicate Value) | Subject Device Performance (K210057) | Remark |
|---|---|---|---|
| General | |||
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | Same as Predicate | Same as Predicate | Same |
| Powdered/Powder-free | Powder-free | Powder-free | Said to be "Powdered free" in table for subject device |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Dimensions | Compliance with ASTM D6319-19. Differences do not raise new safety/performance questions. | ||
| Length, mm (all sizes) | Predicate: 230 min | Subject: 230 (S, M, L, XL) | Subject device has a tolerance of $\pm 10$ mm, while the predicate has "min" |
| Width, mm | Predicate: XS(75), S(85), M(95), L(105), XL(115) $\pm 5$ | Subject: S(80), M(95), L(110), XL(120) $\pm 10$ | Different exact values and sizes, but both claim to meet ASTM D6319-19 |
| Thickness, mm: Finger | Predicate: 0.05 min | Subject: 0.08 $\pm 0.03$ | Different values, but both claim to meet ASTM D6319-19 |
| Thickness, mm: Palm | Predicate: 0.05 min | Subject: 0.08 $\pm 0.03$ | Different values, but both claim to meet ASTM D6319-19 |
| Physical Properties (Before Aging) | ASTM D6319-19 / Predicate: 14MPa, min | Subject: 14MPa, min | Same |
| Tensile Strength | ASTM D6319-19 / Predicate: 500% min | Subject: 500% min | Same |
| Ultimate Elongation | |||
| Physical Properties (After Aging) | ASTM D6319-19 / Predicate: 14MPa, min | Subject: 14MPa, min | Same |
| Tensile Strength | ASTM D6319-19 / Predicate: 400% min | Subject: 400% min | Same |
| Ultimate Elongation | |||
| Freedom from Holes | ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same |
| Powder Content | ASTM D6124 / Predicate requirements for ASTM D6124 | 0.03 mg per glove (meets ASTM D6124) | Same |
| Biocompatibility - Irritation | ISO 10993-10:2010 / Predicate: not an irritant | Not an irritant (Comply with ISO10993-10) | Same |
| Biocompatibility - Sensitization | ISO 10993-10:2010 / Predicate: not a sensitizer | Not a sensitizer (Comply with ISO10993-10) | Same |
| Biocompatibility - Cytotoxicity | ISO 10993-5:2009 / Predicate: not cytotoxic | Not cytotoxic | Similar |
2. Sample size used for the Test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of a dataset for an AI/algorithm, as the device is a physical product (medical glove). The "tests" mentioned are non-clinical standard conformance tests (e.g., physical property testing, biocompatibility).
- Sample Size: The sample sizes for each specific standard test (e.g., number of gloves for tensile strength, number of gloves for hole detection) are not explicitly stated in this summary but would be defined by the respective ASTM and ISO standards (e.g., ASTM D6319, ASTM D5151).
- Data Provenance: Not specified, but the testing was conducted to verify compliance with international standards (ISO, ASTM). The manufacturer is in China (Real Star Medical Technology Co., Ltd. in Dongying, China).
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 as the device is a physical product (medical glove) and the evaluation involves standard physical and chemical testing, not clinical diagnosis by experts or expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation relies on meeting objective criteria defined by recognized standards (ASTM, ISO), not on subjective interpretation requiring adjudication.
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
Not applicable. This is a medical glove, not an AI diagnostic or assistance device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims is defined by the objective measurement criteria and thresholds established within the referenced international standards (ASTM D6319-19, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, ISO 10993-5:2009). For example, "Tensile Strength (Before Aging) $\ge$ 14MPa" is a ground truth established by the ASTM D6319-19 standard.
8. The sample size for the training set
Not applicable. There is no training set for a physical medical device. The device's manufacturing processes are subject to quality system regulations, but this is distinct from "training data" for an algorithm.
9. How the ground truth for the training set was established
Not applicable.
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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 31, 2021
Real Star Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K210057
Trade/Device Name: Blue Nitrile Exam Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 4, 2021 Received: January 11, 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.
Jiangsong Jiang -S (Affiliate)
For 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 Ouality Center for Devices and Radiological Health
Enclosure
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510(k) Summary (K210057)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Real Star Medical Technology Co., Ltd. Name: Address: Youdi Industry Park in Dongying District, Dongying City 257100, Shandong, China. Phone Number: +86-13953305660 Contact: Nie Jian Date of Preparation: Jan.04,2021
Designated Submission Correspondent
Mr. Boyle Wang 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: Blue Nitrile Exam Glove, Powder Free Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
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 Blue Nitrile Exam Glove, Powder Free 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 blue. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K210057) | Predicated Device(K171422) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | Same | ||
| Intended Use | The Blue NitrileExam Glove,Powder Free is anon-steriledisposable deviceintended formedical purposesthat is worn on theexaminer's handsor finger to preventcontaminationbetween patientand examiner. | The Nitrile PowderFree patientexamination gloveis a non-steriledisposable deviceintended formedical purposesthat is worn on theexaminer's handsor finger to 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 |
Table1-General Comparison
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| Free Blue, Non-Sterile | Examination Glove,Non-Sterile | ||
|---|---|---|---|
| -- | ---------------------------- | ----------------------------------- | -- |
| Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| PredicateDevice(K171422) | Length, mm | XS230 | S230 | M230 | L230 | XL230 | min |
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Designation | Size | Tolerance | |||||
| Subject Device(K210057) | Length, mm | S230 | M230 | L230 | XL230 | $\pm 10$ | |
| Width, mm | 80 | 95 | 110 | 120 | $\pm 10$ | ||
| Thickness, mm: | |||||||
| Finger | 0.08 | $\pm 0.03$ | |||||
| Palm | 0.08 | $\pm 0.03$ | |||||
| 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,so the differences do not raise any new safety or performance questions.
Table3 Performance Comparison
| Item | Subject device(K210057) | 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 withASTMD6319 | Same | |||
| Freedom from Holes | Be free fromholes whentested in | Be free fromholes whentested in | Same |
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| accordancewithASTMD5151AQL=2.5 | accordancewithASTMD5151AQL=2.5 | ||
|---|---|---|---|
| Powder Content | 0.03 mg perglove | Meet therequirementsof ASTMD6124 | Same |
Table4 Safety Comparison
| Item | Subject device(K210057) | Predicateddevice(K171422) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization)Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Under theconditions ofthe study, notan irritantUnderconditions ofthe study, nota sensitizer. | Comply withISO10993-10 | Same |
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn VitroCytotoxicity) | Underconditions ofthe study,deviceextract is notcytotoxic | / | Similar |
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 D5151-06(Reapproved2015), 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 Blue Nitrile Exam Glove, Powder Free, is as safe, as effective, and performs as well as or better than the legally marketed predicated device cleared under 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.