(104 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.
This document describes the premarket notification for the "Disposable Nitrile Medical Examination Glove". The acceptance criteria and the study proving the device meets these criteria are detailed through a series of tables and text.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | Pass for all sizes | ||
| Length (mm) | ≥ 230 | XS, S, M, L, XL: > 230 | |
| Width (mm) | XS: 75 ± 5S: 85 ± 5M: 95 ± 5L: 105 ± 5XL: 115 ± 5 | XS: 77-79S: 82-86M: 95-97L: 104-106XL: 115-117 | |
| Thickness (mm) - Finger | ≥ 0.05 | XS: 0.10-0.12S: 0.09-0.12M: 0.08-0.12L: 0.09-0.13XL: 0.11-0.12 | |
| Thickness (mm) - Palm | ≥ 0.05 | XS: 0.06-0.10S: 0.07-0.09M: 0.06-0.09L: 0.06-0.09XL: 0.06-0.08 | |
| ASTM D5151 - Watertightness Test for Detection of Holes | Freedom from Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaksS: 1/125 leaksM: 0/125 leaks (Implied Pass based on AQL 2.5) |
| ASTM D6124 - Powder Content | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | XS: 0.01 mg/gloveS: 0.02 mg/gloveM: 0.03 mg/gloveL: 0.01 mg/gloveXL: 0.02 mg/glove (Pass) |
| ASTM D412 - Physical Properties (Before Aging) | Tensile Strength | ≥ 14 MPa | XS: 15.3-16.3S: 15.6-19.2M: 15.9-17.3L: 15.3-17.2XL: 15.3-17.1 (Pass) |
| Ultimate Elongation | ≥ 500% | XS: 525-579S: 518-571M: 515-575L: 521-562XL: 523-568 (Pass) | |
| ASTM D412 - Physical Properties (After Aging) | Tensile Strength | ≥ 14 MPa | (Results not explicitly listed but labeled "Pass") |
| Ultimate Elongation | ≥ 400% | (Results not explicitly listed but labeled "Pass") | |
| ISO 10993-5 - Cytotoxicity | Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is not cytotoxic to L-929 cells (Pass) |
| ISO 10993-10 - Irritation | Irritation | Non-irritating | Under the conditions of the study, not an irritant (Pass) |
| ISO 10993-10 - Sensitization | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer (Pass) |
2. Sample size used for the test set and the data provenance
- ASTM D5151 (Watertightness): For sizes XS, S, and M, 125 gloves were tested for each size (e.g., XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks). The sample sizes for L and XL are not explicitly stated, but the test methodology implies a standardized approach across sizes.
- Other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility): Specific sample sizes for these tests are not explicitly provided in the document.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective, beyond stating that non-clinical tests were conducted to verify the device met all design specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests conducted are non-clinical, laboratory-based tests evaluating the physical and biological properties of the medical examination glove against recognized international and national standards (e.g., ASTM, ISO). Ground truth, in the context of expert consensus, is not relevant for these types of tests.
4. Adjudication method for the test set
Not applicable. The tests are standardized laboratory procedures with objective measurements against predefined acceptance criteria. There is no mention of expert adjudication for interpreting results.
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 a submission for a medical examination glove, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance evaluation of the Disposable Nitrile Medical Examination Glove is based on widely accepted, published national and international standards for medical gloves. Specifically:
- Physical properties (dimensions, tensile strength, elongation): ASTM D6319 and ASTM D412.
- Freedom from holes: ASTM D5151.
- Powder content: ASTM D6124.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity): ISO 10993-10 and ISO 10993-5.
These standards define the objective and measurable criteria that the device must meet.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set".
9. How the ground truth for the training set was established
Not applicable (as it's not an AI/ML device, there is no training set).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2021
Siyang Threeguard Medical Supplies Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211131
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 23, 2021 Received: June 28, 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 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) K211131
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 (K211131)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Siyang Threeguard Medical Supplies Co.,Ltd. Address: East of Nanhai Road and South of Guilin Road,Economic Development Zone, Siyanq County,Sugian City,Jiangsu,223799 China. Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: July.29,2021
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
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 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.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K211131) | Predicate Device(K171422) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | Disposable NitrileMedicalExamination Gloveis a disposabledevice intendedfor medicalpurposes that isworn on theexaminer's handsto preventcontaminationbetween patientand examiner. | The DisposablePowder Free NitrileExamination Glove,White/ Blue/ Black/Pink Color is adisposable deviceintended formedical purposesthat is worn on theexaminer's handsto 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,glove size andquantity | Single-useindication, powderfree, device color,device name, glovesize and quantity,Non-Sterile | Same |
Table1-General Comparison
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| Non-Sterile | ||||
|---|---|---|---|---|
| -- | ------------- | -- | -- | -- |
| PredicateDevice(K171422) | Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | ||||
| 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 | ||||||
| Subject Device(K211131) | Designation | Size | Tolerance | |||||
| XS | S | M | L | XL | ||||
| 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 | ||||||
| Remark | Same |
Table2 Device Dimensions Comparison
Table3 Performance Comparison
| Table3 Performance Comparison | |||||
|---|---|---|---|---|---|
| Item | Subject device(K211131) | Predicate 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 withASTMD6319 | Same | |||
| Freedom from Holes | Be free fromholes whentested inaccordancewithASTMD5151AQL=2.5 | Be free fromholes whentested inaccordancewithASTMD5151AQL=2.5 | Same |
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| Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | Meet the requirements of ASTM D6124 | Same |
|---|---|---|---|
| ---------------- | --------------------------------------------- | ------------------------------------- | ------ |
Table4 Safety Comparison
| Item | Subjectdevice(K211131) | Predicatedevice(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 VitroCytotoxicity) | Underconditions ofthe study,deviceextract is notcytotoxic | / | 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.
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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: 75±5;S: 85±5;M: 95±5;L: 105±5;XL: 115±5 | Width:XS: 77-79;S: 82-86M: 95-97L: 104-106XL: 115-117Pass | ||
| Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | XS:Finger: 0.10-0.12Palm: 0.06-0.10 | ||
| S:Finger: 0.09-0.12Palm: 0.07-0.09 | |||
| M:Finger: 0.08-0.12Palm: 0.06-0.09 | |||
| L:Finger: 0.09-0.13Palm: 0.06-0.09 | |||
| XL:Finger: 0.11-0.12Palm: 0.06-0.08Pass | |||
| ASTM D5151 | WatertightnessTest forDetection ofHoles | Meet the requirements ofASTM D5151 AQL 2.5 | XS:0/125 leaksS:1/125 leaksM:0/125 leaks |
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| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS:0.01mg/glove;S:0.02mg/glove;M:0.03mg/glove;L:0.01mg/glove;XL:0.02mg/glove;Pass | ||||||
|---|---|---|---|---|---|---|---|---|---|
| ASTM D412 | Physical properties | Before Aging | Tensile Strength | ≥14MPa | XS:15.3-16.3S:15.6-19.2M:15.9-17.3L:15.3-17.2XL:15.3-17.1Pass | ||||
| Ultimate Elongation | ≥500% | XS: 525-579S:518-571M:515-575L:521-562XL:523-568Pass | |||||||
| After Aging | Tensile Strength | ≥14MPa | |||||||
| Ultimate Elongation | ≥400% | ||||||||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells.Pass |
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| ISO 10993-10 | Irritation | Non-irritating | Under theconditions of thestudy, not an irritant.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 is as safe, as effective, and performs as well as or better than the legally marketed predicated device under 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.