(144 days)
The Disposable Nitrile Medical 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 blue. The subject device is non-sterile.
Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Gloves (K210691)
The provided document describes the acceptance criteria and performance data for the Disposable Nitrile Medical Examination Glove (K210691) in comparison to the predicate device (K171422). The study primarily focuses on non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results for 3 Lots) | Outcome |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test (Length) | XS/S: ≥220 mm; M/L/XL: ≥230 mm | Lot1, Lot2, Lot3: >230 mm | Pass |
| ASTM D6319 | Physical Dimensions Test (Width) | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | Lot1: XS: 78-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116Lot2: XS: 79-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116Lot3: XS: 78-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116 | Pass |
| ASTM D6319 | Physical Dimensions Test (Thickness) | Finger: ≥0.05 mm; Palm: ≥0.05 mm | Lot1: Finger: 0.11-0.13, Palm: 0.06-0.07Lot2: Finger: 0.11-0.13, Palm: 0.06-0.07Lot3: Finger: 0.11-0.13, Palm: 0.07 | Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Lot1: 0/125 leaksLot2: 0/125 leaksLot3: 0/125 leaks | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | Lot1: 0.09 mg/gloveLot2: 0.06 mg/gloveLot3: 0.08 mg/glove | Pass |
| ASTM D412 | Physical properties (Before Aging - Tensile Strength) | ≥14 MPa | Lot1: 28-36Lot2: 28-33Lot3: 23-33 | Pass |
| ASTM D412 | Physical properties (Before Aging - Ultimate Elongation) | ≥500% | Lot1: 510-570Lot2: 480-565Lot3: 515-566 | Pass |
| ASTM D412 | Physical properties (After Aging - Tensile Strength) | ≥14 MPa | Lot1: 27-33Lot2: 28-33Lot3: 28-32 | Pass |
| ASTM D412 | Physical properties (After Aging - Ultimate Elongation) | ≥500% | Lot1: 485-535Lot2: 480-530Lot3: 485-533 | Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. | Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. | Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The sample size for the test set is not explicitly stated as a single number but is indicated by the "3 Lots" tested for physical properties, watertightness, and powder content. For the watertightness test (ASTM D5151), a sample size of 125 gloves per lot was tested. The data provenance is China, as the manufacturer, Jiangsu Cureguard Glove Co., Ltd., is located in China. The testing appears to be prospective as it was conducted to demonstrate compliance with standards for a new device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (medical examination glove) does not typically involve human expert interpretation or ground truth establishment in the same way an AI diagnostic tool would. The ground truth for this device is based on objective, quantitative measurements and standardized laboratory test procedures derived from established ASTM and ISO standards. Therefore, the concept of "experts" establishing ground truth for individual cases is not directly applicable here. The "experts" would be the scientists and technicians performing the standardized tests in a laboratory setting, adhering to the specified methodologies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the testing conducted for this medical device involves objective measurements and standardized laboratory methods, not subjective interpretation requiring adjudication among human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's assistance is evaluated. For medical examination gloves, the performance evaluation is based on physicochemical and biological properties against established standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable to the device under review. The device is a physical medical glove, not an algorithm or software. The performance evaluation is inherently "standalone" in the sense that the glove's properties are measured directly, without human interpretation in a diagnostic loop.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is objective laboratory measurements and compliance with established international standards (ASTM and ISO). This includes:
- Physical dimensions (length, width, thickness) measured against specified ranges.
- Mechanical properties (tensile strength, ultimate elongation) measured against minimum requirements.
- Barrier integrity (freedom from holes) measured against AQL (Acceptable Quality Level).
- Chemical properties (powder content) measured against a maximum limit.
- Biocompatibility (cytotoxicity, irritation, sensitization) evaluated through in vitro and in vivo (though described as "in vitro" for cytotoxicity, the irritation and sensitization tests typically involve animal or human models as per ISO 10993-10, even if the results are presented as "non-irritant" or "non-sensitizing" without detailing the specific model here) tests against pass/fail criteria.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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July 30, 2021
Jiangsu Cureguard Glove Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K210691
Trade/Device Name: Disposable Nitrile Medical Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 15, 2021 Received: June 22, 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.
For Clarence W. Murray, III, Ph.D. 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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Indications for Use
510(k) Number (if known) K210691
Device Name Disposable Nitrile Medical Examination Glove
Indications for Use (Describe)
The Disposable Nitrile Medical 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 (K210691)
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, Sugian , Jiangsu, 223800 China. Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: Jun.30,2021
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: Disposable Nitrile Medical 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 Medical 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 blue. The subject device is non-sterile.
| Item | Subject Device(K210691) | Predicated Device(K171422) |
|---|---|---|
| Item | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | Disposable Nitrile MedicalExamination Glove is adisposable device intendedfor medical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Disposable Powder FreeNitrile Examination Glove,White/ Blue/ Black/ Pink Coloris a disposable deviceintended for medical purposesthat is worn on the examiner'shands to preventcontamination between patientand examiner. |
| Material | Nitrile | Nitrile |
| Powdered orPowered free | Powdered free | Powdered free |
| Design Feature | Ambidextrous | Ambidextrous |
| Colorant | Blue | White/ Blue/ Black/ Pink |
| Labeling Information | Single-useindication,powder free, device color,device name, glove size andquantity,Non-Sterile | Single-use indication, powderfree, device color, devicename, glove size and quantity,Non-Sterile |
| Dimensions(mm) | Length:XS/S: $\geq$ 220;M/L/XL: $\geq$ 230;Width:XS: 70 $\pm$ 10;S: 80 $\pm$ 10; | Length: $\geq$ 230;Width:XS: 75 $\pm$ 5;S: 85 $\pm$ 5;M: 95 $\pm$ 5;L: 105 $\pm$ 5; |
7.0 Technological Characteristic Comparison Table
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| M: 95±10; | XL: 115±5 | ||||
|---|---|---|---|---|---|
| L: 110±10; | |||||
| XL: 120±10 | |||||
| Thickness(mm) | Finger: ≥0.05; | Finger: ≥0.05; | |||
| Palm: ≥0.05 | Palm: ≥0.05 | ||||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min |
| UltimateElongation | 500% min | UltimateElongation | 500% min | ||
| AfterAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | |
| UltimateElongation | 400%min | UltimateElongation | 400%min | ||
| Freedom fromHoles | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Be free from holes when testedin accordance withASTMD5151 AQL=2.5 | |||
| Powder Content | Meet the requirements ofASTM D6124 | ||||
| Biocompatibility | ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizerISO 10993-5Under conditions of thestudy, device extract is notcytotoxic | Comply withISO 10993-10Comply with ISO 10993-5 |
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.
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.
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ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | PhysicalDimensionsTest | Length(mm):XS/S:≥220;M/L/XL: ≥230; | Lot1:Length: >230 |
| Width(mm):XS: 70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Width:XS: 78-80;S: 85-86M: 95-96L: 105-106XL: 115-116 | ||
| Lot2:Length: >230Width:XS: 79-80S: 85-86M: 95-96L: 105-106XL: 115-116Lot3:Length: >230Width:XS: 78-80S: 85-86M: 95-96L: 105-106XL: 115-116Pass | |||
| Thickness (mm) :Finger: ≥0.05Palm: ≥0.05 | Lot1:Finger: 0.11-0.13Palm: 0.06-0.07Lot2:Finger: 0.11-0.13Palm: 0.06-0.07Lot3: |
Table 2: Performance Characteristic Comparison
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| Finger: 0.11-0.13Palm: 0.07Pass | |||||
|---|---|---|---|---|---|
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Lot1:0/125 leaksLot2:0/125 leaksLot3:0/125 leaksPass | ||
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | Lot1:0.09mg/glove;Lot2:0.06mg/glove;Lot3:0.08mg/glove;Pass | ||
| ASTM D412 | Physical properties | Before Aging | Tensile Strength | ≥14MPa | Lot 1:28-36Lot2:28-33Lot3:23-33Pass |
| Ultimate Elongation | ≥500% | Lot1:510-570Lot 2:480-565Lot3:515-566Pass | |||
| After Aging | Tensile Strength | ≥14MPa | Lot 1:27-33Lot2:28-33Lot3:28-32Pass | ||
| Ultimate Elongation | ≥500% | Lot1: |
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| Elongation | 485-535 | ||
|---|---|---|---|
| Lot 2: | |||
| 480-530 | |||
| Lot3: | |||
| 485-533 | |||
| Pass | |||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditionsof the study, did notshow potentialtoxicity to L-929cells.Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under theconditions of thestudy, not anirritant.Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditionsof the study, not asensitizer.Pass |
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, K210691 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.