(78 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 document is a 510(k) Premarket Notification for a Blue Nitrile Exam Glove, Powder Free. It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device, not a study proving a device meets acceptance criteria for an AI/ML-based diagnostic or therapeutic product. Therefore, it does not contain the information required to answer the specific questions related to acceptance criteria, test sets, expert involvement, MRMC studies, or training sets for such a device.
The document primarily focuses on demonstrating that the subject device (the new glove) is "as safe, as effective, and performs as well as or better than" a predicate device (an existing glove) based on non-clinical testing of physical properties and biocompatibility.
Here's how the provided information relates to acceptance criteria, but note it's for a physical medical device (glove) and not an AI system:
1. A table of acceptance criteria and the reported device performance
The document provides tables ("Table3 Performance Comparison" and "Table4 Safety Comparison") that effectively function as a comparison of the subject device's performance against the predicate device, which implies certain performance acceptance criteria are met (i.e., being equivalent or better than the predicate, which itself met standards).
Here's an interpretation of the performance and safety "acceptance criteria" and "reported device performance" based on the provided tables:
| Item | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device K210058) |
|---|---|---|
| Physical Properties (Before Aging) | ||
| Tensile Strength | 14 MPa, min (Comply with ASTM D6319) | 14 MPa, min |
| Ultimate Elongation | 500% min (Comply with ASTM D6319) | 500% min |
| Physical Properties (After Aging) | ||
| Tensile Strength | 14 MPa, min (Comply with ASTM D6319) | 14 MPa, min |
| Ultimate Elongation | 400% min (Comply with ASTM D6319) | 400% min |
| Freedom from Holes | ||
| Test Method | Be free from holes when tested in accordance with ASTMD5151 | Be free from holes when tested in accordance with ASTMD5151 |
| AQL | AQL=2.5 | AQL=2.5 |
| Powder Content | ||
| Limit | 0.05 mg per glove (Meet requirements of ASTM D6124) | 0.05 mg per glove |
| Biocompatibility | ||
| Irritation (ISO 10993-10) | Not an irritant | Under the conditions of the study, not an irritant |
| Sensitization (ISO 10993-10) | Not a sensitizer | Under conditions of the study, not a sensitizer |
| Cytotoxicity (ISO 10993-5) | Device extract is not cytotoxic | Under conditions of the study, device extract is not cytotoxic |
2. Sample sizes used for the test set and the data provenance
The document does not specify sample sizes for these tests (e.g., how many gloves were tested for tensile strength or holes). It refers to standard test methods (e.g., ASTM D6319, ASTM D5151), which would define the sample sizes for those tests. The data provenance is implied to be from the manufacturer's own testing facilities in China ("Great Harvest Trading Co., Ltd." in Shandong, China). The testing is non-clinical, not retrospective or prospective in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical glove, not an AI system requiring expert consensus on medical images or diagnoses. The "ground truth" here is objective physical and chemical measurements (e.g., direct measurement of strength, elongation, hole presence, chemical content).
4. Adjudication method for the test set
Not applicable. The tests are standard objective measurements, not subjective human assessments 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 not an AI/ML-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-based diagnostic device.
7. The type of ground truth used
The ground truth for this device's performance is established by objective physical and chemical testing standards, such as ASTM D6319 for physical properties, ASTM D5151 for holes, ASTM D6124 for powder content, and ISO 10993 for biocompatibility. These are laboratory measurements, not expert consensus, pathology, or outcomes data in the medical imaging/diagnosis context.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal 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 30, 2021
Great Harvest Trading Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K210058
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: March 16, 2021 Received: March 22, 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
{1}------------------------------------------------
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
{2}------------------------------------------------
{3}------------------------------------------------
510(k) Summary
K210058
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Great Harvest Trading Co., Ltd. Name: Xinghe Road, Dongying City 257100, Shandong, China Address: Phone Number: +86-13508943885 Contact: Chongfeng Zhao Date of Preparation: Mar.16,2021
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 | Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Ever Global (Vietnam) Enterprise Corp Disposable Powder Free Nitrile Examination Glove, White/ Device: Blue/ Black/ Pink Color 510(k) number: K171422
5.0 Indication for Use
{4}------------------------------------------------
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
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device(K210058) | 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 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, glovesize and quantity,Nitrile GlovePowder Free Blue, | Single-useindication, powderfree, device color,device name, glovesize and quantity,Disposable PowderFree NitrileExamination Glove | Same |
Table1-General Comparison
{5}------------------------------------------------
| Non-Sterile | Non-Sterile | ||
|---|---|---|---|
| -- | ------------- | ------------- | -- |
| PredicateDevice(K171422) | Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | ||||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | ||
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ | ||
| Thickness, mm | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Subject Device(K210058) | Designation | Size | Tolerance | |||||
| S | M | L | XL | |||||
| Length, mm | 230 | 230 | 230 | 230 | $\pm 10$ | |||
| 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(K210058) | Predicateddevice(K171422) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | White/ Blue/Black/ Pink | Same | ||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | 14MPa, min | Same |
| UltimateElongation | 500% min | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa, min | 14MPa, min | Same | |
| UltimateElongation | 400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply with ASTM D6319 | Same | |||
| Freedom from Holes | Be free fromholes whentested inaccordancewith | Be free fromholes whentested inaccordancewith | Same |
{6}------------------------------------------------
| ASTMD5151 | ASTMD5151 | ||
|---|---|---|---|
| AQL=2.5 | AQL=2.5 | ||
| Powder Content | 0.05 mg perglove | Meet therequirements ofASTM D6124 | Same |
| Item | Subjectdevice(K210058) | 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 | Comply withISO10993-10 | Same |
| Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization)Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn VitroCytotoxicity) | Underconditions ofthe study, nota sensitizer.Underconditions ofthe study,deviceextract is notcytotoxic | / | Similar |
Table4 Safety Comparison
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 complies with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
{7}------------------------------------------------
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 Blue Nitrile Exam Glove, Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device Disposable Powder Free Nitrile Examination Glove 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.