(87 days)
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner.
The subject device can be available in six specifications: XS、S、M、L、XL and XXL.
This document is a 510(k) Premarket Notification for Nitrile Patient Examination Gloves, which are Class I devices. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not involve AI or complex medical imaging analysis. Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of medical device submission.
Here's an analysis of the provided text in the context of the requested information, focusing on what is relevant and explicitly stated:
Device: Nitrile Patient Examination Gloves (K211434)
This product is a simple, non-sterile, disposable examination glove. Its acceptance criteria and performance are based on established physical, chemical, and biocompatibility standards for such devices, not on complex algorithmic performance like AI.
1. Table of Acceptance Criteria and Reported Device Performance
The core of the performance evaluation is found in "Table 3 Performance Comparison" and the more detailed "Test Methodology" and "Results" table within Section 8.0 "Summary of Non-clinical Testing."
| Item | Test Methodology | Acceptance Criteria | Reported Device Performance/Results |
|---|---|---|---|
| Physical Dimensions | ASTM D6319 | Length (mm): XS/S: ≥220; M/L/XL: ≥230 | Length: >230 (all sizes, meeting criteria) |
| Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; XXL: 130±10 | XS: 78-80; S: 86-89; M: 97-99; L: 117-119; XL: 116-118; XXL: 128-131 (all Pass) | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.07-0.13 (Pass); Palm: 0.07-0.11 (Pass) | ||
| Physical Properties | ASTM D412 | Before Aging: Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 15.2-17.6 MPa (Pass); Ultimate Elongation: 520-579% (Pass) |
| After Aging: Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 15.3-17.5 MPa (Pass); Ultimate Elongation: 519-580% (Pass) | ||
| Freedom from Holes | ASTM D5151 | AQL=2.5 (Be free from holes when tested) | 2/125, 0/125, 0/125, 1/125, 0/125, 0/125 leaks (Pass) |
| Powder Content | ASTM D6124 | < 2.0mg (Meet the requirements of ASTM D6124) | 0.05, 0.06, 0.08, 0.07, 0.09, 0.06 mg (Pass) |
| Biocompatibility | ISO 10993-5 | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells (Pass) |
| ISO 10993-10 | Non-irritating | Under conditions of the study, not an irritant (Pass) | |
| ISO 10993-10 | Non-sensitizing | Under conditions of the study, not a sensitizer (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document provides specific sample sizes for certain tests within the "Results" section of the non-clinical testing summary:
- Watertightness Test (ASTM D5151): Indicated by "2/125, 0/125, 0/125, 1/125, 0/125, 0/125 leaks." This suggests a sample size of 125 gloves per test run, with 6 runs shown (total 750 gloves tested for holes). However, the specific methodology of ASTM D5151 for an AQL of 2.5 involves sampling plans based on lot size, which isn't detailed here beyond the reported results.
- Powder Content (ASTM D6124): Six data points (0.05, 0.06, 0.08, 0.07, 0.09, 0.06) are reported, suggesting 6 samples were tested.
- Physical properties (ASTM D412): Results are shown across six sizes (XS, S, M, L, XL, XXL) for a range of values. The exact number of samples tested per size is not explicitly stated but implies multiple measurements per characteristic per size.
- Biocompatibility (ISO 10993-5, ISO 10993-10): Specific sample numbers are not provided, as these are typically conducted in accordance with the standard, which defines the test methods and sample requirements.
- Data Provenance: Not explicitly stated, but implies the testing was conducted by the manufacturer or a contracted lab to generate data for the 510(k) submission. There is no indication of country of origin for the data itself outside of the manufacturer's location (Zhangjiagang, China). The data is by nature prospective, as it's generated specifically for the submission to prove compliance with standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This is not an AI/imaging device. Ground truth for these criteria (e.g., tensile strength, presence of holes, cytotoxicity) is established by adherence to globally recognized, standardized test methodologies (ASTM, ISO) and laboratory measurements, not by expert human interpretation or consensus.
4. Adjudication Method for the Test Set
Not Applicable. See point 3. Testing involves objective, quantitative measurements against predefined standards.
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. This is not an AI/imaging device. No human-in-the-loop study or MRMC study was performed or required.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI/imaging device.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective, measurable criteria defined by international standards (ASTM, ISO). For example:
- Physical Dimensions: Measured directly using calibrated instruments against specified length, width, and thickness ranges.
- Physical Properties (Tensile Strength, Elongation): Measured using standardized mechanical testing equipment (e.g., universal testing machine) according to ASTM D412.
- Freedom from Holes: Determined by standardized watertightness test (filling with water and checking for leaks) according to ASTM D5151, with results evaluated against an Acceptable Quality Level (AQL).
- Powder Content: Measured gravimetrically according to ASTM D6124.
- Biocompatibility: Determined by laboratory tests (e.g., cell culture for cytotoxicity, animal/in-vivo tests for irritation/sensitization) according to ISO 10993 series.
8. The Sample Size for the Training Set
Not Applicable. This device does not involve a "training set" in the context of machine learning or AI models. It's a manufactured product whose quality is assessed through conventional engineering and biological testing.
9. How the Ground Truth for the Training Set was Established
Not Applicable. See point 8.
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August 11, 2021
Zhangjiagang Huayuan Protective Equipment 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: K211434
Trade/Device Name: Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA
Dear Boyle Wang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 5, 2021. Specifically, FDA is updating this SE Letter as an administrative correction for the company's name.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, Assistant Director of Office of Surgical and Infection Control Devices, at Tel: 301 -796 - 0270 or Email: Clarence.Murray@fda.hhs.gov.
Sincerely,
Liqun Zhao -S
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 Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The logos are simple and professional in appearance.
August 5, 2021
Zhangjiagang Huayan Protective Equipment 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: K211434
Trade/Device Name: Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 25, 2021 Received: May 10, 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,
Liqun Zhao -S
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211434
Device Name Nitrile Patient Examination Gloves
Indications for Use (Describe)
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger 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 (K211434)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Zhangjiagang Huayuan Protective Equipment Co., Ltd. Name: Address: No.333,Fumin Middle Road,Tanggiao town,Zhangjiagang City,Jiangsu,China Phone Number: +86-13705111918 Contact: Huamei Wang Date of Preparation: Aug.4,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.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: Nitrile Patient Examination Gloves 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 Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner.
The subject device can be available in six specifications: XS、S、M、L、XL and XXL.
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device(K211434) | Predicate Device(K171422) | Remark |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use/Indication for Use | The Nitrile PatientExamination Glovesare non-steriledisposable devicesintended for medicalpurposes that areworn on theexaminer's hands orfinger to preventcontaminationbetween patient andexaminer. | The Nitrile PowderFree patientexamination gloveis a non-steriledisposable deviceintended formedical purposesthat is worn on theexaminer's handsor finger to preventcontaminationbetween patientand examiner. | Same |
| Powdered orPowered free | Powdered orPowered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-use | Single-use | Same |
7.0 Technological Characteristic Comparison Table
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| indication, powder | indication, powder |
|---|---|
| free, device color, | free, device color, |
| device name, glove | device name, glove |
| size and quantity, | size and quantity, |
| Nitrile Glove | Disposable Powder |
| Powder Free, Blue, | Free Nitrile |
| Non-Sterile | Examination Glove, |
| Non-Sterile |
Table2 Device Dimensions Comparison
| Designation | Size | Tolerance | ||||||
|---|---|---|---|---|---|---|---|---|
| PredicateDevice(K171422) | Length, mm | XS230 | S230 | M230 | L230 | XL230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| SubjectDevice(K211434) | Designation | Size | Tolerance | |||||
| Length, mm | XS220 | S220 | M230 | L230 | XL230 | XXL230 | 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 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.
Table3 Performance Comparison
| Item | Subject device(K211434) | Predicate device(K171422) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | White/ Blue/Black/ Pink | Same | ||
| PhysicalProperties | BeforeAging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 500% min | 500% min | Same | ||
| AfterAging | Tensile Strength | 14MPa, min | 14MPa, min | Same | |
| Ultimate Elongation | 400%min | 400%min | Same |
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| Comply with ASTM D6319 | Comply withASTMD6319 | Same | ||
|---|---|---|---|---|
| Freedom from Holes | Be free fromholes whentested inaccordancewithASTMD5151AQL=2.5 | Be free fromholes whentested inaccordancewithASTMD5151AQL=2.5 | Same | |
| Powder Content | Meet therequirementsof ASTMD6124 | Meet therequirementsof ASTMD6124 | Same |
Table4 Safety Comparison
| Subjectdevice(K211434) | Predicateddevice(K171422) | Remark | ||
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Under theconditions ofthe study, notan irritant | ||
| Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Underconditions ofthe study, nota sensitizer. | Comply withISO10993-10 | Same | |
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn Vitro) | Underconditions ofthe study,deviceextract is notcytotoxic | / | / |
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| (Citotoxicity) |
|---|
| -------------------- |
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
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.
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | PhysicalDimensionsTest | Length(mm):XS/S:≥220;M/L/XL: ≥230. | Length: >230 |
| Width(mm): | Width: | ||
| XS: 70±10; | XS: 78-80 | ||
| S: 80±10; | S: 86-89 | ||
| M: 95±10; | M: 97-99 | ||
| L: 110±10; | L: 117-119 | ||
| XL: 120±10; | XL: 116-118 | ||
| XXL: 130±10 | XXL:128-131 | ||
| Pass | |||
| Thickness (mm): | XS: | ||
| Finger: ≥0.05Palm: ≥0.05 | Finger: 0.08-0.10Palm: 0.07-0.09 | ||
| S: | |||
| Finger: 0.07-0.11Palm: 0.07-0.09 | |||
| M: | |||
| Finger: 0.08-0.13Palm: 0.08-0.10 |
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| L: | |||||
|---|---|---|---|---|---|
| Finger: 0.09-0.13 | |||||
| Palm: 0.08-0.11 | |||||
| XL: | |||||
| Finger: 0.08-0.11 | |||||
| Palm: 0.07-0.11 | |||||
| XXL: | |||||
| Finger: 0.08-0.10 | |||||
| Palm: 0.07-0.11 | |||||
| Pass | |||||
| ASTM D5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151 AQL 2.5 | 2/125,0/125,0/125,1/125,0/125,0/125 leaksPass | ||
| ASTM D6124 | PowderContent | Meet the requirements of ASTM D6124 < 2.0mg | 0.05,0.06,0.08,0.07,0.09,0.06Pass | ||
| ASTM D412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | XS:15.4-17.3S: 15.3-16.9M: 15.2-17.1L: 15.4-17.6XL: 15.3-17.1XXL: 15.3-17.4Pass |
| UltimateElongation | ≥500% | XS:524-569S: 525-568M: 521-570L: 527-567XL: 520-570XXL: 529-579Pass | |||
| AfterAging | TensileStrength | ≥14MPa |
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| Elongation | S: 522-570M: 520-569L: 521-567XL: 528-563XXL: 519-580Pass | ||
|---|---|---|---|
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions ofthe 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 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, Nitrile Patient Examination Gloves,are as safe, as effective, and perform as well as or better than the legally marketed predicated device in 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.