(169 days)
The Disposable Nitrile Examination Glove 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 Black/Lavender/Navy Blue/Burgundy. It can be available in five specifications: XS,S,M,L and XL.
The subject device is non-sterile.
This document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove. It details the device's characteristics and compares it to a predicate device (K171422) to establish substantial equivalence.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: $\ge$ 220; M/L/XL: $\ge$ 230; Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Length(mm): > 230/Pass; Width(mm): XS: 70-77 /Pass; S: 77-86 /Pass; M: 95-99/ Pass; L: 109-114/ Pass; XL:117-120/ Pass |
| N/A (Section 6) | Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.08-0.11/Pass; Palm: 0.08-0.11/Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 15.3-17.9MPa/Pass; Ultimate Elongation: 496-588%/Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 20.0-44.5MPa/Pass; Ultimate Elongation: 450-5710%/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures out of 125 samples tested) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.03-0.07mg/Pass |
| ISO 10993-5 | Biocompatibility - Cytotoxicity | Under conditions of the study, device extract is not cytotoxic (implied expectation, as the reported result confirms this) | Under conditions of the study, device extract is cytotoxic (This seems to be a typo/inconsistency in the document. The acceptance criterion from the predicate comparison is "Under conditions of the study, device extract is cytotoxic", implying the absence of cytotoxicity is the goal. The reported performance for ISO 10993-5 is the phrase "Toxicity" with the acceptance criteria being "Under conditions of the study, device extract is cytotoxic". This is highly confusing. Based on standard biocompatibility testing, the desired outcome for cytotoxicity is non-cytotoxic. However, the "Table 2 - Summary of non-clinical performance testing" explicitly lists "Toxicity" as the purpose and "Under conditions of the study, device extract is cytotoxic" as both the acceptance criteria and implied result. This is a critical discrepancy in the provided text. For a medical device, a cytotoxic extract would typically not be acceptable. Assuming the intent was for it to be non-cytotoxic, and that the "Results" column would show "Pass" for non-cytotoxicity, there's a clear error in the document as presented.) |
| ISO 10993-11 | Biocompatibility - Systemic Toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo | Non-acute systemic toxicity / Pass |
| ISO 10993-10 | Biocompatibility - Irritation | Under the conditions of the study, not an irritant | Non-irritating / Pass |
| ISO 10993-10 | Biocompatibility - Sensitization | Under conditions of the study, not a sensitizer | Non-sensitizing / Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Watertightness Test (ASTM D5151): The reported performance "0/125/Pass" indicates a sample size of 125 units were tested.
- Other tests: The sample sizes for the remaining tests (Physical Dimensions, Thickness, Physical Properties, Powder Content, Biocompatibility) are not explicitly stated in the provided document.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is Jiangsu Cureguard Glove Co., Ltd. in China, so it's reasonable to infer the testing was conducted in China, but this is not explicitly confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device (Disposable Nitrile Examination Glove) is a Class I medical device, which typically relies on established engineering and materials standards (e.g., ASTM, ISO) rather than expert human interpretation of complex medical images or outcomes.
- Therefore, the concept of "experts" establishing a "ground truth" as it would apply to AI/imaging diagnostics does not apply to the performance testing described for this device. The ground truth is defined by the objective measurement specifications in the referenced standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Again, due to the nature of the device and testing (physical and chemical properties measured against objective standards), no adjudication method of expert opinions was used or necessary. The results are based on objective measurements.
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
- An MRMC study is not applicable to this type of device. This device is a disposable examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical product, not an algorithm or software. The "standalone" performance is simply the device's ability to meet the specified physical, chemical, and biological criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this device's performance testing is defined by objective engineering and material standards (e.g., ASTM D6319 for dimensions, ASTM D412 for physical properties, ASTM D5151 for watertightness, ASTM D6124 for powder content, and ISO 10993 series for biocompatibility). These standards provide the measurable criteria that the device must meet.
8. The sample size for the training set
- This is not applicable as the device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This is not applicable as the device is a physical product, not an AI model.
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March 15, 2022
Jiangsu Cureguard Glove Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K213121
Trade/Device Name: Disposable Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: February 9, 2022 Received: February 14, 2022
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, M.D., 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) K213121
Device Name Disposable Nitrile Examination Glove
Indications for Use (Describe)
The Disposable Nitrile Examination Glove 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 K213121
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Jiangsu Cureguard Glove Co., Ltd. Address: No. 65 Shenzhen Road, The Economic Development Zone, Suqian, Jiangsu, 223800 China. Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: Mar 15, 2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Nitrile Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, 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 Disposable Nitrile Examination Glove 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 Black/Lavender/Navy Blue/Burgundy. It can be available in five specifications: XS,S,M,L and XL.
The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device(K213121) | Predicated Device(K171422) | Remark |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable NitrileExamination Glove is adisposable device intendedfor medical purposes that isworn on the examiner's handsto prevent contaminationbetween patient andexaminer. | The Disposable Powder FreeNitrile Examination Glove,White/ Blue/ Black/ Pink Coloris a disposable deviceintended for medicalpurposes that is worn on theexaminer's hands to preventcontamination betweenpatient and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Black/ Lavender/ Navy Blue/Burgundy | White/ Blue/ Black/ Pink | DifferentAnalysis 1 |
| Labeling Information | Single-use indication, powderfree, device color, devicename,glove sizeandquantity, Non-Sterile | Single-use indication, powderfree, device color,devicename, glovesizeandquantity, Non-Sterile | Same |
| Dimensions(mm) | Length:XS/S: ≥220; | Length:S/M/L/XL: ≥230; | DifferentAnalysis 2 |
Table1-General Comparison
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| M/L/XL: ≥230; | Width: | Width: | TestMethod | Purpose | Acceptance Criteria | Results | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| XS: 70±10; | XS: 75±5; | ASTMD6319 | PhysicalDimensionsTest | Length (mm):XS/S: $\ge$ 220; | Length(mm):> 230/Pass; | |||||
| S: 80±10; | S: 85±5; | M/L/XL: $\ge$ 230; | ||||||||
| M: 95±10; | M: 95±5; | Width (mm):XS: 70±10; | Width(mm):XS: 70-77 /Pass | |||||||
| L: 110±10; | L: 105±5; | S: 80±10; | S: 77-86 /Pass | |||||||
| XL: 120±10. | XL: 115±5 | M: 95±10; | M: 95-99/ Pass | |||||||
| Thickness(mm) | Finger: ≥0.05;Palm: ≥0.05 | Finger: ≥0.05;Palm: ≥0.05 | Same | L: 110±10; | L: 109-114/ Pass | |||||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | Same | XL: 120±10. | XL:117-120/ Pass | ||
| UltimateElongation | 500% min | UltimateElongation | 500% min | Same | Thickness (mm):Finger: $\ge$ 0.05 | Thickness (mm):Finger: 0.08-0.11/Pass | ||||
| AfterAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | Same | Palm: $\ge$ 0.05 | Palm: 0.08-0.11/Pass | |||
| UltimateElongation | 400%min | UltimateElongation | 400%min | Same | ASTMD5151 | WatertightnessTestforDetectionofHoles | Meet the requirements of ASTM D5151AQL 2.5 | 0/125/Pass | ||
| Freedom from Holes | Be free from holes when tested in accordance withASTMD5151 AQL=2.5 | Be free from holes when tested in accordance withASTMD5151 AQL=2.5 | Same | ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 <2.0mg | 0.03-0.07mg/Pass; | |||
| Powder Content | Meet the requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | Same | |||||||
| Biocompatibility | ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer | ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer | Same | |||||||
| ISO 10993-5Under conditions of the study,device extract is cytotoxic | / | / | ||||||||
| ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo | / | / |
Analysis 1: The subject device (Black/ Lavender/ Navy Blue/ Burgundy) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.
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8.0 Summary of Non-clinical 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 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
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.
Table 2 - Summary of non-clinical performance testing
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| ASTMD412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | 15.3-17.9MPa/Pass; |
|---|---|---|---|---|---|
| UltimateElongation | ≥500% | 496-588%/Pass; | |||
| AfterAging | TensileStrength | ≥14MPa | 20.0-44.5MPa/Pass; | ||
| UltimateElongation | ≥400% | 450-5710%/Pass; | |||
| ISO10993-5 | Cytotoxicity | Toxicity | Under conditions ofthe study, deviceextract is cytotoxic. | ||
| ISO10993-11 | Cytotoxicity | Non- acute systemictoxicity | Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass | ||
| ISO10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant/ Pass | ||
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer./ Pass |
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 subject device Disposable Nitrile Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicated device 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.