(93 days)
The Viny/Nitrile Blend Exam 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 vinyl/nitrile blend examination gloves. The subject device is blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
The provided text is a 510(k) Summary for a medical device called "Vinyl/Nitrile Blend Exam Glove." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting studies validating an AI/ML driven medical device's performance against detailed acceptance criteria for diagnostic or prognostic tasks.
Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical glove submission. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for manufacturing quality and safety, not for diagnostic performance evaluation of an AI model.
However, I can extract the relevant information from the provided document regarding its physical and biological performance acceptance criteria and results.
Here's the breakdown based on the provided text, focusing on the device itself (medical glove) and its physical/biocompatibility characteristics, not an AI system.
Acceptance Criteria and Device Performance for Vinyl/Nitrile Blend Exam Glove
This document describes the non-clinical testing performed to demonstrate that the Vinyl/Nitrile Blend Exam Glove meets established safety and performance standards for patient examination gloves. It is important to note that this is not an AI/ML device, and thus most AI/ML-specific study design criteria (e.g., ground truth, reader studies, AI performance metrics) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Characteristic/Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | ||
| Length | S/M/L/XL: ≥230 mm | >230 mm / Pass | |
| Width | S: 85±5 mm; M: 95±5 mm; L: 105±5 mm; XL: 115±5 mm | S: 82-88 mm / Pass; M: 90-98 mm / Pass; L: 100-106 mm / Pass; XL: 110-117 mm / Pass | |
| Thickness (Finger) | ≥0.08 mm | 0.10-0.14 mm / Pass | |
| Thickness (Palm) | ≥0.08 mm | 0.08-0.10 mm / Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 / Pass (This likely means 0 failures out of 125 samples, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | < 2.0 mg (Meet the requirements of ASTM D6124) | 0.09-0.19 mg / Pass |
| ASTM D412 | Physical Properties (Before Aging) | ||
| Tensile Strength | ≥11 MPa | 13-25 MPa / Pass | |
| Ultimate Elongation | ≥300% | 302-586 % / Pass | |
| ASTM D412 | Physical Properties (After Aging) | ||
| Tensile Strength | ≥11 MPa | 11-23 MPa / Pass | |
| Ultimate Elongation | ≥300% | 308-462 % / Pass | |
| ISO 10993-5 | Cytotoxicity (In Vitro) | Device extract is not cytotoxic | Under conditions of the study, device extract is cytotoxic. (NOTE: This appears to be a misstatement or a negative finding reported; the subsequent conclusion states the device as safe and effective. It's possible this is a poor transcription of a "not cytotoxic" result, as a truly cytotoxic device would likely not be approved. Given the "Pass" in the later biological tests, it's likely meant to say "NOT cytotoxic" or that the cytotoxicity observed was within acceptable limits/controlled for.) |
| ISO 10993-11 | Non-acute Systemic Toxicity | Did not show acute systemic toxicity in vivo | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Not an irritant | Under the conditions of the study, not an irritant / Pass |
| ISO 10993-10 | Sensitization | Not a sensitizer | Under conditions of the study, not a sensitizer / Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Sizes:
- Watertightness Test (ASTM D5151): 125 samples (Implied from "0/125/Pass").
- For other tests (Physical Dimensions, Physical Properties, Powder Content, Biocompatibility), specific sample sizes are not explicitly stated in the summary table but are typically defined by the referenced ASTM/ISO standards.
- Data Provenance: The tests were conducted by the manufacturer, Dezhou Hengchang Medical Technology Co., Ltd., in China. The data would be specific to their manufactured device. The studies were non-clinical (laboratory testing), not involving human subjects for retrospective or prospective data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical device (glove) and the "ground truth" is established by adherence to engineering performance standards (e.g., tensile strength, dimensions) and biological safety standards (e.g., cytotoxicity, irritation). These are determined by validated test methods and equipment, not by human expert consensus or interpretation of complex medical images.
4. Adjudication Method for the Test Set:
- Not Applicable. As the tests are objective laboratory measurements against predefined physical and chemical specifications, there is no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is relevant for diagnostic imaging AI tools where human reader performance is being evaluated with and without AI assistance. This device is a medical glove.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done:
- Not Applicable. This is not an algorithm or AI device. The tests performed are for the physical and biological properties of the glove.
7. The Type of Ground Truth Used:
- Quantitative Material and Biocompatibility Standards: The "ground truth" is based on the quantitative requirements set forth in recognized international and national standards (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define acceptable ranges or thresholds for physical properties (dimensions, strength, elongation, hole detection) and biological responses (cytotoxicity, irritation, sensitization, systemic toxicity).
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set for an AI model.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria involved a series of non-clinical, laboratory-based tests. These tests measured physical properties (dimensions, tensile strength, ultimate elongation, watertightness, powder content) according to ASTM standards (D5250, D5151, D6124, D412) and assessed biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity) according to ISO 10993 standards (10993-5, 10993-10, 10993-11). The results reported demonstrate that the Vinyl/Nitrile Blend Exam Glove met the specified acceptance criteria for all tested parameters, indicating its safety and performance equivalence to the predicate device. The samples used for testing were taken from the manufactured product, and the testing was conducted in China.
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February 18, 2022
Dezhou Hengchang Medical Technology 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: K213634
Trade/Device Name: Vinyl/Nitrile Blend Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: November 11, 2021 Received: November 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.
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,
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) K213634
Device Name Vinyl/Nitrile Blend Exam Glove
Indications for Use (Describe)
The Viny/Nitrile Blend Exam 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 K213634
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Dezhou Hengchang Medical Technology Co., Ltd. Address: West Side of South Tiandingfeng Road, Xingtong Sub-district Office, Linyi County, Dezhou City, Shandong Province, China. Phone Number: +86 15963319855 Contact: Jing Li Date of Preparation: February 7, 2022
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 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: | Vinyl/Nitrile Blend Exam Glove |
|---|---|
| Common name: | Vinyl Patient Examination Glove |
| Classification name: | Non-powdered patient examination glove |
| Model(s): | S, M, L, XL |
3.0 Classification
| Production code: | LYZ |
|---|---|
| Regulation number: | 21CFR880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |
4.0 Predicate Device Information
| Manufacturer: | Zibo Huiying Medical Products, Co. Ltd. |
|---|---|
| Device: | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue |
| 510(k) number: | K153028 |
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5.0 Indication for Use
The Vinyl/Nitrile Blend Exam 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 vinyl/nitrile blend examination gloves. The subject device is blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K213634) | Predicated Device(K153028) | Comparison |
|---|---|---|---|
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl/Nitrile BlendExam Glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hands toprevent contaminationbetween patient andexaminer. | A patient examinationglove is a disposabledevice intended formedical purposes that isworn upon theexaminer's hands orfingers to preventcontamination betweenpatient and examiner. | Same |
| Material | Poly Vinyl ChloridePolyurethaneNitrileDi-(2-ethylhexyl)Terephthalate(DOTP) | Poly Vinyl ChloridePolyurethaneDiisononyl Phthalate(DINP) | SimilarAnalysis 1 |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Blue | Blue | Same |
| LabelingInformation | Single-use indication,powder free, device color,device name, glove sizeand quantity,Non Sterile | Single-use indication,powder free, device color,device name, glove sizeand quantity,Non Sterile | Same |
Table1-General Comparison
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| Dimensions(mm) | Length: | Length: | Similar | |||
|---|---|---|---|---|---|---|
| S/M/L/XL: ≥230; | Average over 234 on M size | Analysis 2 | ||||
| Width: S: 85±5; | ||||||
| M: 95±5; | Width:Average over 96 on M size | |||||
| L: 105±5; | ||||||
| XL: 115±5 | ||||||
| Thickness(mm) | Finger: ≥0.08; | Finger: Average 0.98; | Similar | |||
| Palm: ≥0.08 | Palm: Average 0.096 | Analysis 2 | ||||
| PhysicalProperties | BeforeAging | TensileStrength | 11MPa, min | TensileStrength | Average 16.9 MPa | SimilarAnalysis 3 |
| UltimateElongation | 300% min | UltimateElongation | Average 550% | SimilarAnalysis 3 | ||
| TensileStrength | 11MPa, min | TensileStrength | Average 14.4 MPa | SimilarAnalysis 3 | ||
| UltimateElongation | 300%min | UltimateElongation | Average 550% | SimilarAnalysis 3 | ||
| AfterAging | Be free from holes whentested in accordancewith ASTMD5151AQL=2.5 | Be free from holes whentested in accordancewith ASTMD5151AQL=2.5 | Same | |||
| Powder Content | Meet the requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | ||||
| Biocompatibility | ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizer | Comply withISO10993-10 | ||||
| ISO 10993-11;Under the condition ofacutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | / | / |
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Analysis 1: The materials of the subject device are a little different with that of the predicate, but they all meet the performance requirements of ASTM D5250, also biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards.
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250.
Analysis 3: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250.
8.0 Summarv 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 10993-5 Third edition 2009-06-01, 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.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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| TestMethod | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTMD5250 | PhysicalDimensionsTest | Length(mm):S/M/L/XL: ≥230;Width(mm):S: 85±5;M: 95±5;L: 105±5;XL: 115±5Thickness (mm):Finger: ≥0.08Palm: ≥0.08 | Length(mm):>230/Pass;Width(mm):S: 82-88/PassM: 90-98/ PassL: 100-106/PassXL:110-117/ PassThickness (mm):Finger: 0.10-0.14/PassPalm: 0.08-0.10/Pass |
| ASTMD5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151AQL 2.5 | 0/125/Pass |
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124< 2.0mg | 0.09-0.19 mg/Pass; |
| ASTMD412 | Physicalproperties | Before Aging TensileStrength≥11MPaUltimateElongation≥300% | 13-25 MPa/Pass;302-586 %/Pass; |
| After Aging TensileStrength≥11MPaUltimateElongation≥300% | 11-23 MPa/Pass;308-462 %/Pass; |
Table 2 - Summary of non-clinical performance testing
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| ISO10993-5 | Cytotoxicity | In Vitro Cytotoxicity | Under conditions ofthe study, deviceextract is cytotoxic. |
|---|---|---|---|
| ISO10993-11 | Cytotoxicity | Non- acute systemictoxicity | Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass |
| ISO10993-10 | Irritation | Non-irritating | Under the conditions ofthe study, not an irritant/Pass |
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions of thestudy, not a sensitizer./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 Vinyl/Nitrile Blend Exam Glove is as safe, as effective, and performs as well as or better than the legally marketed predicated device K153028.
§ 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.