(92 days)
The Vinyl 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 vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for Vinyl Examination Gloves. This is a medical device focused on physical properties and biocompatibility, not an AI/imaging device. Therefore, many of the requested criteria regarding AI model evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, and ground truth establishment methods) are not applicable to this document.
However, I can extract the relevant information regarding the device's performance against its acceptance criteria based on the provided non-clinical testing summary.
Here's the breakdown:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length (mm): S/M/L/XL: ≥230Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5Thickness (mm): Finger: ≥0.08; Palm: ≥0.08 | Length (mm): > 230 /PassWidth (mm): S: 81-88 /Pass M: 90-98/ Pass L: 100-109/ Pass XL:110-118/ PassThickness (mm): Finger: 0.08-0.14/Pass Palm: 0.08/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 (AQL 2.5) | 0/125 /Pass (Implies 0 failures out of 125 samples, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.10-0.18mg /Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥11MPaUltimate Elongation: ≥300% | Tensile Strength: 11-21MPa /PassUltimate Elongation: 300-477% /Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥11MPaUltimate Elongation: ≥300% | Tensile Strength: 11-17MPa /PassUltimate Elongation: 303-412% /Pass |
| ISO 10993-5 | Cytotoxicity | In Vitro Cytotoxicity Standard | Under conditions of the study, device extract is cytotoxic. (Note: The acceptance criteria here imply "no cytotoxicity" for "Pass". The document states it is cytotoxic but still lists it as "Pass" somehow, which is contradictory or requires further context from the original submission about acceptable levels of cytotoxicity or if this refers to a specific predicate comparison point not fully detailed in the summary table. Given the overall "Pass" conclusion, it might be that the observed cytotoxicity is within an acceptable range for this specific device type, or mitigated, but the table itself presents a direct contradiction if "In Vitro Cytotoxicity" implies "no cytotoxicity"). Re-evaluating based on the "Pass" in the results column means that despite the wording, it met the defined criteria for "In Vitro Cytotoxicity" for this device. However, the ISO 10993-5 criterion is usually "Non-cytotoxic". This is a point of ambiguity in the provided text. |
| ISO 10993-11 | Systemic Toxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / 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 |
Non-Applicable / Not Provided Information (for this type of device submission)
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: For specific tests, sample sizes are sometimes implicitly mentioned (e.g., "0/125" for watertightness), but a general "test set" sample size for overall performance evaluation as would be described for an AI model is not applicable or provided. The testing is per standard procedures for each physical/chemical property.
- Data Provenance: Not applicable in the same sense as for clinical data. The tests are laboratory-based conformance tests. The manufacturer is Dezhou Hengchang Medical Technology Co., Ltd. from China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. Ground truth for these physical and biocompatibility tests is established by objective measurements and standardized laboratory procedures/protocols, not expert consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for subjective evaluations or diagnostic tasks, not for objective material properties testing.
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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 for AI-assisted diagnostic devices.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for AI algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on objective measurements and chemical/biological assays conducted according to internationally recognized standards (ASTM, ISO). For example, a "hole" is objectively defined by the ASTM D5151 test, and tensile strength is measured quantitatively.
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The sample size for the training set:
- Not applicable (no AI/machine learning training involved).
-
How the ground truth for the training set was established:
- Not applicable (no AI/machine learning training involved).
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international standards. These tests evaluate the physical properties (dimensions, watertightness, powder content, tensile strength, ultimate elongation) and biocompatibility (cytotoxicity, systemic toxicity, irritation, sensitization) of the Vinyl Examination Gloves. The results demonstrate that the device complies with all specified acceptance criteria derived from these standards (ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10, ISO 10993-11). The conclusion is that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicated device K180861" based on these non-clinical tests. Clinical testing was deemed "not needed for this device."
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February 17, 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: K213625
Trade/Device Name: Vinyl Examination Gloves 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 17, 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.
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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 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, 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) K213625
Device Name Vinyl Examination Gloves
Indications for Use (Describe)
The Vinyl 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 K213625
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: Nov.11, 2021
Designated Submission Correspondent
Mr. Boyle Wang 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 Examination Gloves 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: 21 CFR 880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: ZHICHENG TRADING CO., LTD. Device: Vinyl Examination Glove (Clear, Non-Colored) 510(k) number: K180861
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5.0 Indication for Use
The Vinyl 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 vinyl examination gloves. The subject device's color is clear. 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(K213625) | Predicated Device(K180861) | Comparison |
|---|---|---|---|
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl ExaminationGlove is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Vinyl ExaminationGlove (Clear,Non-Colored) is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hands toprevent contaminationbetween patient andexaminer. | Same |
| Material | Vinyl | Vinyl | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Clear | Clear | Same |
| LabelingInformation | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile | Same |
| Dimensions(mm) | Length:S/M/L/XL: ≥230;Width:S: 85+5; | Length:S≥230;M≥235;L≥245; | SimilarAnalysis 1 |
Table1-General Comparison
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| M: 95±5; | XL≥245; | |||||
|---|---|---|---|---|---|---|
| L: 105±5; | Width: | |||||
| XL: 115±5 | S: 85±5; | |||||
| M: 95±5; | ||||||
| L: 105±5; | ||||||
| XL: 115±5 | ||||||
| Thickness(mm) | Finger: ≥0.08;Palm: ≥0.08 | Finger: ≥0.05;Palm: ≥0.08 | SimilarAnalysis 1 | |||
| PhysicalProperties | BeforeAging | TensileStrength | 11MPa,min | TensileStrength | 15MPa,min | SimilarAnalysis 2 |
| UltimateElongation | 300% min | UltimateElongation | 380% min | SimilarAnalysis 2 | ||
| AfterAging | TensileStrength | 11MPa,min | TensileStrength | 15MPa,min | SimilarAnalysis 2 | |
| UltimateElongation | 300%min | UltimateElongation | 380%min | SimilarAnalysis 2 | ||
| Freedom fromHoles | Be free from holes whentested in accordance withASTMD5151AQL=2.5 | Be free from holes whentested in accordancewith ASTMD5151AQL=1.5 | SimilarAnalysis 3 | |||
| Powder Content | Meet the requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | Same | |||
| Biocompatibility | ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizer | Comply withISO10993-10 | Same | |||
| ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | Under conditions of thestudy, did not showpotential toxicity to L-929cells. Complies with ISO10993-5 | / | ||||
| ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo | / | / |
Analysis 1: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250.
Analysis 2: The tensile strength and ultimate elongation are different with that
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of the predicate, but they all meet the requirements of ASTM D5250.
Analysis 3: Freedom from holes of subject device is similar with that of the predicate, but they all meet the requirements of ASTMD5151.
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.
| 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: 81-88 /PassM: 90-98/ PassL: 100-109/ PassXL:110-118/ PassThickness (mm):Finger: 0.08-0.14/PassPalm: 0.08/Pass |
| ASTM | Watertightness | Meet the requirements of ASTM D5151 | 0/125/Pass |
Table 2 - Summary of non-clinical performance testing
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| D5151 | TestforDetectionofHoles | AQL 2.5 | ||||
|---|---|---|---|---|---|---|
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 < 2.0mg | 0.10-0.18mg/Pass; | |||
| ASTMD412 | Physicalproperties | BeforeAging | TensileStrength | ≥11MPa | 11-21MPa/Pass; | |
| UltimateElongation | ≥300% | 300-477%/Pass; | ||||
| AfterAging | TensileStrength | ≥11MPa | 11-17MPa/Pass; | |||
| UltimateElongation | ≥300% | 303-412%/Pass; | ||||
| 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 conditionsof the study, not anirritant/ Pass | |||
| ISO10993-10 | 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 Vinyl Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicated device K180861.
§ 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.