(109 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 subject device is cobalt blue. The subject device is non-sterile.
This document describes the acceptance criteria and the study that proves the device meets those criteria for Nitrile Patient Examination Gloves (K211012).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): ≥230 | Length: >230 mm (Pass) |
| Width (mm): XS: 80±10 S: 90±10 M: 100±10 L: 110±10 XL: 115±10 XXL: 125±10 | Width (mm): XS: 83-88 S: 90-94 M: 96-100 L: 109-114 XL: 117-121 XXL: 123-126 (Pass) | ||
| Thickness (mm): Finger: ≥0.05 Palm: ≥0.05 | Thickness (mm): XS: Finger: 0.08-0.10, Palm: 0.08-0.10 S: Finger: 0.07-0.11, Palm: 0.08-0.11 M: Finger: 0.08-0.12, Palm: 0.07-0.11 L: Finger: 0.08-0.13, Palm: 0.08-0.11 XL: Finger: 0.08-0.12, Palm: 0.08-0.13 XXL: Finger: 0.08-0.12, Palm: 0.08-0.13 (Pass) | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaks S: 1/125 leaks M: 0/125 leaks L: 0/125 leaks XL: 0/125 leaks XXL: 1/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS: 0.04 mg S: 0.06 mg M: 0.08 mg L: 0.07 mg XL: 0.10 mg XXL: 0.07 mg (Pass) |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa Ultimate Elongation: ≥500% | Tensile Strength: XS: 15.4-16.6 S: 15.6-19.2 M: 15.9-17.3 L: 15.3-17.2 XL: 15.3-17.1 XXL: 15.6-17.2 (Pass) Ultimate Elongation: XS: 542-579 S: 536-571 M: 515-575 L: 521-562 XL: 523-568 XXL: 543-568 (Pass) |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPa Ultimate Elongation: ≥400% | Tensile Strength: XS: 15.3-18.7 XXL: 15.8-17.2 (Pass - Note: Data for other sizes are not explicitly listed in the "Reported Device Performance" column for After Aging Tensile Strength, but "Pass" is indicated overall.) Ultimate Elongation: XS: 549-568 S: 538-570 M: 528-570 L: 523-564 XL: 529-570 XXL: 529-568 (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 document provides specific sample sizes for some tests:
- Watertightness Test (ASTM D5151): 125 samples for each glove size (XS, S, M, L, XL, XXL).
- Data provenance is not explicitly stated (e.g., country of origin). The studies appear to be retrospective as they are testing completed devices against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the ground truth for glove testing is established through standardized laboratory procedures and measurements, not expert clinical consensus.
4. Adjudication Method for the Test Set
This information is not applicable as the testing involves objective measurements against predefined criteria, not subjective interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices involving human interpretation, not for examination gloves.
6. Standalone Performance (Algorithm Only Without Human-in-the Loop Performance)
This information is not applicable. This device is a physical medical device (examination gloves), not an algorithm or AI system. Its performance is inherent to its physical properties, not a software component.
7. Type of Ground Truth Used
The ground truth used for these tests is based on established industry standards and regulatory requirements, specifically:
- ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) - Inferred from the physical properties testing.
- ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of testing physical medical devices like examination gloves. The manufacturing process is controlled to ensure consistent product characteristics.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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July 23, 2021
Huayuan Medical Technology (Shangqiu) Co., Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211012
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: June 17, 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 medical devices and radiation-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, PhD. 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) K211012
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 (K211012)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Huayuan Medical Technology (Shangqiu) Co., Ltd. Address: In The North Yard of West 1000m Road at The Intersection of Zhuangzhou Avenue and Pingyuan Road, Liangyuan District, Shangqiu City, Henan Province,China. Phone Number: +86-13705111918 Contact: Huamei Wang Date of Preparation: Jul.23,2021
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 Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS、S、M、L、XL、XXL
3.0 Classification
LZA Production code: 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 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 subject device is cobalt blue. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K211012) | Predicated Device(K171422) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile PatientExamination Glovesarenon-steriledisposable devicesintended for medicalpurposes that arewornontheexaminer'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 free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-useindication, powderfree, device color,device name, glovesize and quantity,Nitrile GlovePowder Free | Single-useindication, powderfree, device color,device name, glovesize and quantity,Disposable PowderFree Nitrile | Same |
Table1-General Comparison
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| cobalt blue, Non-Sterile | Examination Glove,Non-Sterile | ||
|---|---|---|---|
| -- | ------------------------------ | ----------------------------------- | -- |
| Size | Tolerance | |||||||
|---|---|---|---|---|---|---|---|---|
| Designation | XS | S | M | L | XL | |||
| PredicateDevice(K171422) | 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 | ||||||
| Size | Tolerance | |||||||
| Designation | XS | S | M | L | XL | XXL | ||
| Subject Device(K211012) | Length, mm | 230 | 230 | 230 | 230 | 230 | 230 | min |
| Width, mm | 80 | 90 | 100 | 110 | 115 | 125 | ±10 | |
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | Similar |
Table2 Device Dimensions Comparison
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.
Table3 Performance Comparison
| Item | Subject device(K211012) | Predicateddevice(K171422) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Cobalt Blue | White/ Blue/Black/ Pink | Different | ||
| 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 withASTMD6319 | Same | |||
| Freedom from Holes | Be free fromholes whentested inaccordance | Be free fromholes whentested inaccordance | Same |
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| withASTMD5151AQL=2.5 | withASTMD5151AQL=2.5 | ||
|---|---|---|---|
| Powder Content | Meet therequirementsof ASTMD6124 | Meet therequirementsof ASTMD6124 | Same |
Analysis: The subject device (Cobalt Blue) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.
| Item | Subjectdevice(K211012) | 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 | Same |
| Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Underconditions ofthe study, nota sensitizer. | ||
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn VitroCytotoxicity) | Underconditions ofthe study,deviceextract is notcytotoxic | / |
Table4 Safety Comparison
8.0 Discussion of Non-clinical and Performance Testing
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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):≥230; | Length: >230 |
| Width(mm):XS: 80±10;S: 90±10;M: 100±10;L: 110±10;XL: 115±10;XXL: 125±10 | Width:XS: 83-88S: 90-94M: 96-100L: 109-114XL: 117-121XXL:123-126Pass | ||
| Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | XS:Finger: 0.08-0.10Palm: 0.08-0.10S:Finger: 0.07-0.11Palm: 0.08-0.11M:Finger: 0.08-0.12Palm: 0.07-0.11L:Finger: 0.08-0.13Palm: 0.08-0.11 |
Table 5: Summary of Non-clinical Testing Table
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| XL:Finger: 0.08-0.12Palm: 0.08-0.13 | |||||
|---|---|---|---|---|---|
| XXL:Finger: 0.08-0.12Palm: 0.08-0.13 | |||||
| Pass | |||||
| ASTM D5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151 AQL 2.5 | XS:0/125 leaksS:1/125 leaksM:0/125 leaksL:0/125 leaksXL:0/125 leaksXXL:1/125 leaksPass | ||
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS:0.04 mg;S:0.06 mg;M:0.08 mg;L:0.07 mg;XL:0.10 mg;XXL:0.07Pass | ||
| ASTM D412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | XS:15.4-16.6S:15.6-19.2M:15.9-17.3L:15.3-17.2XL:15.3-17.1XXL:15.6-17.2Pass |
| UltimateElongation | ≥500% | XS:542-579S: 536-571M:515-575L:521-562XL:523-568XXL:543-568Pass | |||
| TensileStrength | |||||
| AfterAging | XL:15.3-18.7XXL:15.8-17.2Pass | ||||
| UltimateElongation | ≥400% | XS:549-568S: 538-570M:528-570L:523-564XL:529-570XXL:529-568Pass | |||
| 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 |
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9.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
Conclusion 10.0
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Patient Examination Gloves, are as safe, as effective, and performs 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.