(135 days)
The Nitrile Patient 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.
The provided document is a 510(k) summary for a Nitrile Patient Examination Glove, which is a Class I device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than complex clinical efficacy studies for novel devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): | Length (mm): |
| XS/S: ≥220 | XS/S: > 220 / Pass | ||
| M/L/XL/XXL: ≥230 | M/L/XL/XXL: > 230 / Pass | ||
| Width (mm): | Width (mm): | ||
| XS: 70 ± 10 | XS: 73-78 / Pass | ||
| S: 80 ± 10 | S: 80-84 / Pass | ||
| M: 95 ± 10 | M: 95-100 / Pass | ||
| L: 110 ± 10 | L: 109-114 / Pass | ||
| XL: 120 ± 10 | XL: 117-121 / Pass | ||
| XXL: 130 ± 10 | XXL: 125-128 / Pass | ||
| Thickness (mm): | Thickness (mm): | ||
| Finger: ≥0.05 | Finger: 0.08-0.13 / Pass | ||
| Palm: ≥0.05 | Palm: 0.08-0.13 / Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125, 1/124, 0/125, 0/125, 0/125, 0/125 leaks / Pass (Implies a low number of leaks, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS: 0.04mg/Pass; S: 0.06mg/Pass; M: 0.06mg/Pass; L: 0.08mg/Pass; XL: 0.07mg/Pass; XXL: 0.10mg/Pass. (All values are < 2.0mg) |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa | XS: 15-17/Pass; S: 15-20/Pass; M: 15-18/Pass; L: 15-18/Pass; XL: 15-18/Pass; XXL: 16-20/Pass. (All values ≥ 14MPa) |
| Ultimate Elongation: ≥500% | XS: 540-561/Pass; S: 530-571/Pass; M: 525-575/Pass; L: 520-565/Pass; XL: 520-570/Pass; XXL: 530-580/Pass. (All values ≥ 500%) | ||
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPa | XS: 15-17/Pass; S: 15-17/Pass; M: 15-17/Pass; L: 15-18/Pass; XL: 14-19/Pass; XXL: 15-27/Pass. (All values ≥ 14MPa) |
| Ultimate Elongation: ≥400% | XS: 545-570/Pass; S: 538-570/Pass; M: 525-570/Pass; L: 525-570/Pass; XL: 525-570/Pass; XXL: 510-560/Pass. (All values ≥ 400%) | ||
| 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 Sizes Used for the Test Set and Data Provenance
The sample sizes for specific tests are mentioned:
- Watertightness Test (ASTM D5151): The results indicate samples of 125 or 124 gloves were tested (e.g., 0/125, 1/124).
- Powder Content (ASTM D6124): Tests were conducted for each glove size (XS, S, M, L, XL, XXL). The exact number of samples per size is not specified but is implied to be sufficient for a representative measurement.
- Physical Properties (ASTM D412): Tests were conducted for each glove size (XS, S, M, L, XL, XXL) both before and after aging. The exact number of samples per size for these mechanical tests is not specified.
- Biocompatibility (ISO 10993-5, ISO 10993-10): The sample sizes for these in vitro and in vivo (animals, not human) biocompatibility tests are not explicitly stated in this summary.
Data Provenance: The document does not specify the country of origin of the data providers for the non-clinical tests. Since the submitter is based in China, it's highly probable the testing was conducted in China or by accredited labs recognized by the Chinese regulatory system. All tests are non-clinical (laboratory-based) and are retrospective in nature, as they assess characteristics of manufactured products.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this device and submission type. The devices are patient examination gloves, and the tests conducted are adherence to international standards for physical properties and biocompatibility. Ground truth in this context is defined by the objective results of these standardized tests, not by expert consensus or interpretations. There are no human "readers" or diagnostic outcomes being evaluated.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data (e.g., medical images) and their decisions need to be resolved or validated, often against a ground truth. The tests for these gloves are objective measurements following established laboratory procedures.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically for diagnostic imaging devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for a medical glove, which does not involve human interpretation of cases or AI assistance in a diagnostic capacity.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Nitrile Patient Examination Glove is established by objective measurements and adherence to recognized international and national standards. Specifically:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-5:2009: 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.
- ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (implied as referenced for Tensile Strength and Ultimate Elongation).
The ground truth is essentially the quantitative limits and qualitative definitions set forth by these standards.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not involved here. The manufacturer produces the gloves, and samples are selected from production for testing against the established standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set. The "ground truth" for evaluating the product's performance is derived from the established and published national and international standards mentioned above.
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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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 21, 2021
Yunnan Huazhiyuan Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K210686
Trade/Device Name: Nitrile Patient 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 18, 2021 Received: June 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.
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
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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 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210686
Device Name Nitrile Patient Examination Glove
Indications for Use (Describe)
The Nitrile Patient 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 (K210686)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Yunnan Huazhiyuan Medical Technology Co., Ltd. Name: Address: Yangjie Industrial Park,Jianshui County,Honghe Hani and Yi Autonomous Prefecture, Yunnan Province,China Phone Number: +86-18252909158 Contact: Yun Gao Date of Preparation: Jun.18th,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: Nitrile Patient Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,S, M, L, XL,XXL
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 Nitrile Patient 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.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K210686) | Predicated Device(K171422) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | Same | ||
| Indications for use | The Nitrile PatientExamination Gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hands topreventcontaminationbetween patient andexaminer. | The Nitrile PowderFree patientexamination glove isa non-steriledisposable deviceintended for medicalpurposes that is wornon the examinershands or finger topreventcontaminationbetween patient andexaminer. | Same |
| Powdered or Poweredfree | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-useindication, powderfree, device color,device name, glovesize and quantity,Non-Sterile | Single-use indication,powder free, devicecolor, device name,glove size andquantity, Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate | Designation | Size | Tolerance |
|---|---|---|---|
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| Device(K171422) | Length, mm | XS | S | M | L | XL | ||
|---|---|---|---|---|---|---|---|---|
| 230 | 230 | 230 | 230 | 230 | min | |||
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Subject Device(K210686) | Designation | XS | S | M | L | XL | XXL | Tolerance |
| Length, mm | 220 | 220 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 95 | 110 | 120 | 130 | ±10 | |
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | SIMILAR |
Analysis: The physical dimensions are little 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.
| Item | Subject device(K210686) | Predicated device(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 withASTM D6319 | Same | |||
| Freedom from Holes | Be free fromholes whentested inaccordance withASTMD5151AQL=2.5 | Be free fromholes whentested inaccordance withASTMD5151AQL=2.5 | Same | ||
| Powder Content | Meet therequirements of | Meet therequirements | Same |
Table3 Performance Comparison
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| ASTM D6124 | ofD6124 | ASTM |
|---|---|---|
| ------------ | ------------- | ------ |
Table4 Safety Comparison
| Item | Subject device(K210686) | Predicateddevice(K171422) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | |||
| Biocompatibility | Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Under theconditions ofthe study, notan irritant | ||
| Sensitization (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Underconditions ofthe study, not asensitizer. | Comply withISO10993-10 | Same | |
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests For InVitro Cytotoxicity) | Underconditions ofthe study, /device extractis not cytotoxic | / | Similar |
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 10993-10:2010 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
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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.
| TestMethod | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| ASTMD6319 | PhysicalDimensionsTest | Length(mm):XS/S:≥220;M/L/XL/XXL:≥230; | Length:XS/S: > 220/Pass;M/L/XL/XXL: > 230/Pass; | ||
| Width(mm):XS:70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10;XXL: 130±10 | Width (mm):XS:73-78/PassS: 80-84 /PassM: 95-100/ PassL: 109-114/ PassXL:117-121/ PassXXL: 125-128/ Pass | ||||
| Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Finger: 0.08-0.13/PassPalm: 0.08-0.13/Pass | ||||
| ASTMD5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151AQL 2.5 | 0/125,1/124, 0/125,0/125, 0/125, 0/125leaks / Pass | ||
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 <2.0mg | XS:0.04mg/Pass;S: 0.06mg/Pass;M: 0.06mg/Pass;L: 0.08mg/Pass;XL: 0.07mg/Pass;XXL: 0.10mg/Pass. | ||
| ASTMD412 | Physicalproperties | BeforeAging | TensileStrength ≥14MPa | XS:15-17/Pass;S:15-20/Pass;M:15-18/Pass;L:15-18/Pass;XL:15-18/Pass;XXL:16-20/Pass. | |
| UltimateElongation ≥500% | XS:540-561/Pass;S:530-571/Pass; | ||||
| ISO10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass | ||
| ISO10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass | ||
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer / Pass | ||
| AfterAging | Tensile Strength | ≥14MPa | XS:15-17/Pass;S:15-17/Pass;M:15-17/Pass;L:15-18/Pass;XL:14-19/Pass;XXL:15-27/Pass | ||
| Ultimate Elongation | ≥400% | XS:545-570/Pass;S:538-570/Pass;M:525-570/Pass;L:525-570/Pass;XL:525-570/Pass;XXL:510-560/Pass. | |||
| M:525-575/Pass;L:520-565/Pass;XL:520-570/Pass;XXL:530-580/Pass |
Table 5 - Summary of non-clinical performance testing
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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 subject 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.