(112 days)
The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The provided text is a 510(k) Premarket Notification from the FDA for "Disposable Nitrile Gloves." This document primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving that it meets acceptance criteria for an AI/algorithm-based diagnostic device through a study with human readers.
Therefore, the information requested in the prompt, such as acceptance criteria for AI algorithms, sample sizes for AI test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth establishment for training sets, and the number and qualifications of experts for ground truth, is not applicable to this document.
The document describes performance testing for a physical medical device (gloves) against established standards for physical properties and biocompatibility.
Here's an analysis based on the information available in the document, framed to address the prompt's structure where possible, but highlighting the inapplicability of AI-specific criteria.
Analysis of Acceptance Criteria and Device Performance (for Disposable Nitrile Gloves)
The document, K211781, describes the submission for Disposable Nitrile Gloves. The "acceptance criteria" in this context refer to the performance specifications and safety standards for the physical product, not for an AI/algorithm. The study presented is a series of non-clinical bench tests and biocompatibility assessments demonstrating the gloves meet these standards and are substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are derived from recognized standards (ASTM and ISO). The reported device performance shows the proposed device meets or exceeds these criteria.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Tests | |||
| ISO 10993-10:2010 (Irritation & Skin Sensitization) | Assess potential contact hazards (skin/mucosal irritation, eye irritation, skin sensitization). | Skin Sensitization: Grades less than 1. Skin Irritation: Primary Irritation Index 0-0.4 (Negligible). | All grades are 0. All animals survived with no abnormal signs. Primary irritation index is 0 (negligible response). |
| ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assess in vitro cytotoxicity. | Viability reduced to <70% of blank indicates cytotoxic potential. | Viab.% of 100% test article extract is 13.7%. Indicates potential toxicity to L-929 in MTT method. (Note: This is a deviation from the "positive" acceptance criteria, but later mitigated by systemic toxicity test). |
| ISO 10993-11:2017 (Systemic Toxicity) | Evaluate potential for medical device materials to cause adverse systemic reactions. | Within 72h, no greater toxicosis response in testing group than control group. | No evidence of systemic toxicity from the extract. (This mitigates the cytotoxicity finding, suggesting it's not systemically toxic). |
| Physical Properties Tests | |||
| ASTM D6124-06 (Reapproved 2017), Residual Powder on Medical Gloves | Determine amount of residual powder. | Powder residue limit of 2.0 mg. | 0.06 mg/glove. (Meets criterion). |
| ASTM D5151-19, Detection of Holes in Medical Gloves | Cover detection of holes in medical gloves. | Samples: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤ 7 gloves for water leakage. | No glove water leakage found. (Meets criterion). |
| ASTM D6319-19, Nitrile Examination Gloves for Medical Application | Covers general requirements (sterility, freedom from holes, dimensions, thickness, physical properties). | Sterility: No need (for this non-sterile device). Freedom from holes: AQL 2.5. Dimensions: (e.g., S: width 80±10mm, L ≥220mm; M: width 95±10mm, L ≥230mm; L: width 110±10mm, L ≥230mm; XL: width 120±10mm, L ≥230mm). Thickness: Finger ≥0.05 mm, Palm ≥0.05 mm. Physical Properties: (Before Aging) Tensile strength ≥14MPa, Ultimate Elongation ≥500%. (After Aging) Tensile strength ≥14MPa, Ultimate Elongation ≥400%. | N.A. for sterility. Freedom from holes: Met (as per D5151). Dimensions: S: width 84-88 mm, L 251-261 mm; M: width 91-95 mm, L 252-256 mm; L: width 103-106 mm, L 250-256 mm; XL: width 118-121mm, L 253-261 mm. (All meet D6319-19 requirements, though different from predicate detailed in Table 2). Thickness: Finger 0.14-0.15 mm, Palm 0.08-0.09 mm. (All meet D6319-19 requirements). Physical Properties: (Before Aging) Tensile strength 14.67-26.48 MPa, Ultimate Elongation 585.48% - 846.81%. (After Aging) Tensile strength 14.40-22.23 MPa, Ultimate Elongation 527.73% - 775.00%. (All meet D6319-19 requirements). |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For Freedom from Holes (ASTM D5151-19): 125 gloves.
- For other physical tests (Dimensions, Thickness, Physical Properties, Powder Content): Not explicitly stated as a "test set" sample size but implied by compliance with ASTM D6319-19, which dictates sampling plans.
- For Biocompatibility Tests (ISO 10993): Animal study sample sizes (for irritation, sensitization, systemic toxicity) are not explicitly stated, but are standard for these in vivo tests. Cell cultures are used for cytotoxicity.
- Data Provenance: The testing was conducted by or on behalf of "Jiangsu Jinke Protective Equipment Co., Ltd" in China. The data would be considered prospective, as it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device. "Ground truth" in this context refers to the measured physical and biological properties of the gloves as determined by validated test methods and laboratory analysis, not by human expert interpretation of images or other data. No human experts were used to establish "ground truth" for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is for a physical medical device. Not an AI diagnostic study.
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. No AI component; therefore, no MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No AI component; therefore, no standalone AI performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For physical properties, the ground truth is established by objective measurements using standardized laboratory equipment and methods (e.g., tensile testers for strength, calipers for dimensions, water for hole detection, chemical analysis for powder content).
- For biocompatibility, the ground truth is established by biological responses observed in validated in vitro (cytotoxicity) or in vivo (irritation, sensitization, systemic toxicity) animal models according to ISO standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; there is no training set in the context of AI.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
Conclusion from the Document:
The document successfully demonstrates that the Disposable Nitrile Gloves meet the performance specifications outlined in relevant ASTM and ISO standards for physical properties and biocompatibility, particularly when compared to the predicate device. The one noted 'potential cytotoxicity' was mitigated by a successful systemic toxicity test. The regulatory submission hinges on substantial equivalence rather than AI performance criteria.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 29, 2021
Jiangsu Jinke Protective Equipment Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608. No.738. Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K211781
Trade/Device Name: Disposable Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 7, 2021 Received: September 23, 2021
Dear Boyle Wang:
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 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, PhD 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) K211781
Device Name Disposable nitrile gloves
Indications for Use (Describe)
The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands 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 K211781
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Jiangsu Jinke Protective Equipment Co., Ltd Address: West Shuangyang Road(South Side), Sihong Economic Development Zone, Suqian, Jiangsu, 223900, China Phone Number: +86-18058186617 Contact: Mia Lai Date of Preparation: 2021.05.27
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Disposable nitrile gloves
Common name: Patient Examination Gloves
Classification name: Non-powdered patient examination glove
Model(s): S, M, L, XL 3.0 Classification
LZA Production code: Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Manufacturer: Ever Global (Vietnam) Enterprise Corp
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Disposable Powder Free Nitrile Examination Glove, White/ Device:
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Blue/ Black/ Pink Color 510(k) number: K171422
5.0 Intended use
The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
7.0 Summarv of Technological Charateristic Comparison
| Item | Proposed device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K211781 | K171422 | Same |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable nitrilegloves is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Disposable PowderFree Nitrile ExaminationGlove, White/ Blue/ Black/Pink Color is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication,powder free, device color,device name, glove sizeand quantity, Disposablenitrile gloves, Non-Sterile | Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposablePowder Free NitrileExamination Glove,Non-Sterile | Same |
Table1-General Comparison
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| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K171422) | XS | S | M | L | XL | ||
| 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 | |||||
| Proposed Device | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Analysis 1 |
Table2 Device Dimensions Comparison
Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19.
| Item | Proposed device | Predicated device | Comparison | ||
|---|---|---|---|---|---|
| Colorant | blue | White/ Blue/ Black/ Pink | Analysis2 | ||
| 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 from holeswhen tested inaccordance withASTMD5151AQL=2.5 | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | SAME | ||
| Powder Content | 0.06 mg/glove | Meet the requirements ofASTM D6124 | SIMILAR |
Table3 Performance Comparison
Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test.
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| Item | Proposed device | Predicated device | Comparison | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | Analysis3 | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Table 4 Safety Comparison
Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe.
8.0 Discussion of non-clinical testing
In summary, the performance testing and biocompaitbility of the subject device was conducted to demonstrate the subject device met the specification and the acceptance criteria in the standards listed below.
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 Disposable nitrile gloves For Medical Application.
ASTM D7160-16, Standard Practice for Determination of Expiration Dating for Medical Gloves
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
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.
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| TestMethodology /Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010BiologicalEvaluation OfMedical Devices- Part 10: TestsFor Irritation AndSkinSensitization. | This part of ISO10993 assessespossible contacthazards fromchemicals releasedfrom medicaldevices,which may produceskin and mucosalirritation, eye irritationor skin sensitization. | Skin Sensitization Test:providedgrades less than 1,otherwise sensitization.Skin Irritation Test:If the primary irritationindex is 0-0,4, theresponse category isNegligible.0,5-1,9 means slight2-4,9 means moderate5-8 means severe | All grades are 0.All animals were survivedand no abnormal signs wereobserved during the study.The primary irritation indexis 0.The response of theproposed device wascategorized as negligibleunder the test condition |
| ISO 10993-5:2009 BiologicalEvaluation OfMedical Devices- Part 5: TestsFor In VitroCytotoxicity | This part of ISO10993 describes testmethods to assessthe in vitrocytotoxicity ofmedical devices. | The viab.% of the100% extract of thetest article is the finalresult, and if viability isreduced to <70% ofthe blank, it hascytotoxic potential. | Viab.% of 100% test articleextract is 13.7%It means the proposeddevice have potentialtoxicity to L-929 in the MTTmethod |
| ISO 10993-11:2017 Biologicalevaluation ofmedical devices- Part 11: Testsfor systemictoxicity | To evaluate thepotential for medicaldevice materials tocause adversesystemic reactions. | Within the monitoringperiod (72 h), if thetoxicosis response oftesting group is notgreater than that ofcontrol group, thetesting sample isregarded asacceptable. | There was no evidence ofsystemic toxicity from theextract. |
| ASTM D6124-06(Reapproved2017), StandardTest Method forResidual Powderon MedicalGloves | This standard isdesigned todetermine theamount ofresidualpowder (or filter-retained mass) foundon medical gloves | powder residue limit of2.0 mg | 0.06 mg /glove |
| ASTM D5151-19Standard TestMethod forDetection ofHoles in MedicalGloves | This test methodcovers the detectionof holes inmedical gloves. | Samples number: 125glovesAQL: 2.5 (ISO 2859)Criterion ≤7 gloves forwater leakage | no glove water leakagefound |
| ASTM D6319-19StandardSpecification forNitrileExaminationGloves forMedicalApplication | This specificationcovers certainrequirements fornitrile rubber glovesused in conductingmedicalexaminations anddiagnostic andtherapeuticprocedures. | Sterility: no needFreedom from holes:pl. Refer to table 3Dimensions:S: width 80±10mmLength ≥220 mmM: width 95±10mmLength ≥230 mmL: width 110±10mmLength ≥230 mmXL: width 120±10mmLength ≥230 mmThickness:Finger ≥0.05 mmPalm ≥0.05 mmPhysical properties:Before agingTensile strength ≥14MPaUltimate Elongation ≥500%After AcceleratedAgingTensile strength ≥14MPaUltimate Elongation ≥400%Powder-free Residue:pl. Refer to table 3 | N.A.Dimensions:S: width: 84-88 mmLength 251-261 mmM: width 91-95 mmLength 252-256 mmL: width 103-106 mmLength 250-256 mmXL: width 118-121mmLength 253-261 mmThickness:Finger 0.14-0.15 mmPalm 0.08-0.09 mmPhysical properties:Before agingTensile strength 14.67-26.48 MPaUltimate Elongation585.48% - 846.81%After Accelerated AgingTensile strength 14.40-22.23 MPaUltimate Elongation527.73% - 775.00%Powder-free Residue:pl. Refer to table 3 |
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9.0 Summary of Clinical Testing:
Clinical testing is not needed for this device.
10.0 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.