(156 days)
The Disposable 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 proposed device is Powder Free Nitrile Examination 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.
This document is a 510(k) Premarket Notification for "Disposable Nitrile Examination Gloves" (K203436) by Shandong Zhushi Pharmaceutical Group Co., Ltd. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (K171422).
The 510(k) submission primarily relies on non-clinical performance testing to demonstrate safety and effectiveness.
Here's an analysis based on your request, focusing on acceptance criteria and study proving device meets criteria:
1. A table of acceptance criteria and the reported device performance
| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 (Skin Sensitization Test) | Assess possible contact hazards from chemicals, specifically skin sensitization. | Grades less than 1. | All grades are 0. All animals were survived and no abnormal signs were observed during the study. (Pass) |
| 2 | ISO 10993-10:2010 (Skin Irritation Test) | Assess possible contact hazards from chemicals, specifically skin irritation. | Primary irritation index is 0-0.4 for "Negligible" response category. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. (Pass) |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assess the in vitro cytotoxicity of medical devices. | Viability is not reduced to <70% of the blank. | Viab.% of 100% test article extract is 70.9%. It means the proposed device has no potential toxicity to L-929 in the MTT method. (Pass) |
| 4 | ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves | Determine the amount of residual powder found on medical gloves. | Powder residue limit of 2.0 mg. | 0.02 mg (Pass, well below the limit) |
| 5 | ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves. | Covers the detection of holes in medical gloves. | Samples number: 125 gloves; AQL: 2.5 (ISO 2859); Criterion ≤7 gloves for water leakage. | No glove water leakage found. (Pass) |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. | Covers certain requirements for nitrile rubber gloves used in medical examinations and diagnostic/therapeutic procedures. | Dimensions: - XS: width 70±10mm, length ≥220 mm - S: width 80±10mm, length ≥220 mm - M: width 95±10mm, length ≥230 mm - L: width 110±10mm, length ≥220 mm - XL: width 75±6mm, length ≥220 mm - Thickness (Finger & Palm): ≥0.05 mm Physical Properties (Before Aging): - Tensile strength ≥14MPa - Ultimate Elongation ≥500% Physical Properties (After Accelerated Aging): - Tensile strength ≥14MPa - Ultimate Elongation ≥400% | Dimensions: - XS: Avg width 71.38 mm, Avg Length 221.25 mm. Avg Finger thickness 0.05 mm, Avg Palm thickness 0.07 mm. - S: Avg width 82.63 mm, Avg Length 221.12 mm. Avg Finger thickness 0.055 mm, Avg Palm thickness 0.066 mm. - M: Avg width 93.4 mm, Avg Length 232.13 mm. Avg Finger thickness 0.053 mm, Avg Palm thickness 0.079 mm. - L: Avg width 102.75mm, Avg Length 231.4 mm. Avg Finger thickness 0.054 mm, Avg Palm thickness 0.076 mm. - XL: Avg width 115.4mm, Avg Length 231.7 mm. Avg Finger thickness ≥0.054 mm, Avg Palm thickness ≥0.08 mm. Physical Properties (Before Aging): - Avg Tensile strength 25.4 MPa - Avg Ultimate Elongation ≥608% Physical Properties (After Accelerated Aging): - Avg Tensile strength 25MPa - Avg Ultimate Elongation 505% (All dimensions and physical properties meet or exceed the specified criteria. Sterility is N.A. (not applicable as it's non-sterile), and Freedom from Holes and Powder-free Residue refer to tests #5 and #4 respectively, which passed). |
2. Sample sizes used for the test set and the data provenance
- ISO 10993-10 (Skin Sensitization & Irritation): The document doesn't explicitly state the exact sample size (number of animals) used for the biological evaluation tests beyond stating "All animals were survived" and "the primary irritation index is 0". Typically, these standards specify minimum animal counts.
- ISO 10993-5 (In Vitro Cytotoxicity): "Viab.% of 100% test article extract is 70.9%". This refers to cell culture tests (L-929 cells). The exact number of replicates or passages is not specified.
- ASTM D5151 (Freedom from Holes): Sample size: 125 gloves.
- ASTM D6124 (Residual Powder) & ASTM D6319 (Dimensions, Physical Properties): The sample sizes for these physical and chemical tests are not explicitly stated in the document, but they are typically governed by the respective ASTM standards (e.g., a certain number of gloves per batch/size for dimensional checks or tensile strength tests).
- Data Provenance: The document does not explicitly state the country of origin for the test data generation. However, the submitter is "Shandong Zhushi Pharmaceutical Group Co., Ltd" from "Shandong, China" and the designated submission correspondent is in "Shanghai, China." Given this information, it is highly likely that the testing was conducted in China. The data would be considered prospective as it was generated specifically for this 510(k) submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as this is a submission for a Class I medical device (Disposable Nitrile Examination Gloves), which primarily relies on engineering and material performance standards. It is not an AI/imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in diagnostic imaging or clinical trials, not for physical performance testing of gloves.
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 section is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of these gloves is established through direct physical, chemical, and biological testing against established scientific standards (ISO and ASTM). For example:
- Physical Properties (Tensile Strength, Elongation, Dimensions): The ground truth is the measured physical characteristic of the glove compared against the specified numerical limits in ASTM D6319.
- Freedom from Holes: The ground truth is the absence or presence of water leakage as per ASTM D5151.
- Residual Powder: The ground truth is the measured powder amount compared against the limit in ASTM D6124.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity): The ground truth is the biological response observed in the in-vitro or in-vivo (animal) models according to ISO 10993 standards, compared against defined non-toxic or non-irritant criteria.
8. The sample size for the training set
This section is not applicable. There is no "training set" for this device as it is not a machine learning or AI-based product.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set.
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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.
April 28, 2021
Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K203436
Trade/Device Name: Disposable 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: March 18, 2021 Received: March 25, 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.
Bifeng Qian -S
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203436
Device Name Disposable Nitrile Examination Gloves
Indications for Use (Describe)
The Disposable 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.
| 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 K203436
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Shandong Zhushi Pharmaceutical Group Co., Ltd Name: Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Phone Number: +86-15764021131 Contact: Junhui Zhu Date of Preparation: Apr. 27th, 2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Disposable Nitrile Examination Gloves
Common name: Patient Examination Gloves
Classification name: Non-powdered patient examination glove
XS, S, M, L, XL Model(s): 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 Disposable Powder Free Nitrile Examination Glove, White/ Device: Blue/ Black/ Pink Color
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510(k) number: K171422
5.0 Intended use
The Disposable 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 proposed device is Powder Free Nitrile Examination 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 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| 510(k) number | K203436 | K171422 | Same |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable NitrileExamination Gloves is adisposable device intendedfor medical purposes thatis worn 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 Examination 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 | ||||
| XS | S | M | L | XL | |||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 90 | 100 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | SIMILAR |
Table 2 Device Dimensions Comparison
Table3 Performance Comparison
| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Colorant | blue | White/ Blue/ Black/ Pink | Analysis1 | |
| PhysicalProperties | BeforeAging | TensileStrength14MPa, min | 14MPa, min | SAME |
| UltimateElongation500%min | 500%min | SAME | ||
| AfterAging | TensileStrength14MPa, min | 14MPa, min | SAME | |
| UltimateElongation400%min | 400%min | SAME | ||
| 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 | 0.02 | Meet the requirements of ASTM D6124 | SIMILAR |
Analysis1: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility and performance tests, the test results shown that the color difference does not affect the safety and efficacy of proposed device.
Table4 Biocompatibility Testing Comparison
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| Material | Nitrile | Nitrile | SAME |
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| Biocompatibility | Irritation | with | Similar | ||
|---|---|---|---|---|---|
| Irritation | Under the conditions of the study, not an irritant | ||||
| Sensitization | Under conditions of the study, not a sensitizer. | ||||
| Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | with | SIMILAR | ||
| Label and Labeling | Meet FDA's Requirement | MeetRequirement | FDA's | SAME |
8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| No. | Name of the TestMethodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010Biological Evaluation OfMedical Devices - Part10: Tests For IrritationAnd Skin Sensitization. | This part of ISO10993 assessespossible contacthazards fromchemicalsreleased frommedical devices,which mayproduce skin and | Skin SensitizationTest:providedgrades less than 1,otherwisesensitization. | All grades are 0.All animals were survived and noabnormal signs were observedduring the study. |
| 2 | mucosal irritation,eye irritation orskin 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 | The primary irritation index is 0.The response of the proposeddevice was categorized asnegligible under the testcondition | |
| 3 | ISO 10993-5:2009Biological Evaluation OfMedical Devices - Part5: Tests For In VitroCytotoxicity | This part of ISO10993 describestest methods toassess the 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 70.9%It means the proposed devicehave no potential toxicity to L-929 in the MTT method |
| 4 | ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powder onMedical Gloves | This standard isdesigned todetermine theamount ofresidualpowder (or filter-retained mass)foundon medical gloves | powder residue limit of2.0 mg | 0.02mg |
| 5 | ASTMD5151-06(Reapproved2015),Standard Test Methodfor Detection of Holes inMedical Gloves. | This test methodcovers thedetection of holesinmedical gloves. | Samples number: 125glovesAQL: 2.5 (ISO 2859)Criterion ≤7 gloves forwater leakage | no glove water leakage found |
| 6 | ASTMD6319-10(Reapproved2015),StandardSpecification For NitrileExamination Gloves ForMedical Application. | This specificationcovers certainrequirements fornitrile rubbergloves used inconductingmedicalexaminations anddiagnostic andtherapeuticprocedures. | 1. Sterility: no need2. Freedomfromholes: pl. Refer to No.5 in table 53. Dimensions:XS: width 70±10mmLength ≥220 mmS: width 80±10mmLength ≥220 mmM: width 95±10mmLength ≥230 mmL: width 110±10mmLength ≥220 mmXL: width 75±6mmLength ≥220 mmThickness:Finger ≥0.05 mmPalm ≥0.05 mm4. Physical properties:Before agingTensile strength ≥14MPaUltimate Elongation ≥500%After AcceleratedAgingTensile strength ≥14MPaUltimate Elongation ≥400%5. Powder-freeResidue:pl. Refer to No. 4 intable 5 | 1. N.A.2. Please refer to No. 5 in table 53. Dimensions:XS: Average width 71.38 mmAverage Length 221.25 mmThickness:Average Finger 0.05 mmAverage Palm 0.07 mmS: Average width 82.63 mmAverage Length 221.12 mmThickness:Average Finger 0.055 mmAverage Palm 0.066 mmM: Average width 93.4 mmAverage Length 232.13 mmThickness:Average Finger 0.053 mmAverage Palm 0.079 mmL: Average width 102.75mmAverage Length 231.4 mmThickness:Average Finger 0.054 mmAverage Palm 0.076 mmXL: Average width 115.4mmAverage Length 231.7 mmThickness:Average Finger ≥0.054 mmAverage Palm ≥0.08 mm4. Physical properties:Before agingAverage Tensile strength 25.4MPaAverage Ultimate Elongation ≥608%After Accelerated AgingAverage Tensile strength 25MPaAverage Ultimate Elongation505%5. Powder-free Residue:pl. Refer to No. 4 in table 5 |
Table 5 Summary of Non-Clinical Performance Testing
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9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10.0 Conclusion
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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.