(44 days)
The Disposable 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 patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
The provided document is a 510(k) summary for a medical device called "Disposable Vinyl Examination Glove." It details the non-clinical testing performed to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device.
Here's the information broken down according to your request:
Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length (mm): ≥230 | Length: ≥230/ Pass |
| Width (mm): XS: 75±5; S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | XS: 74-77/ Pass | ||
| S: 83-87 /Pass | |||
| M: 96-97/ Pass | |||
| L: 104-108/ Pass | |||
| XL: 114-117/ Pass | |||
| Thickness (mm): Finger: ≥0.08; Palm: ≥0.08 | Finger: 0.09-0.14/Pass | ||
| Palm: 0.10-0.13/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 1.5 | 0/125 leaks / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.01 mg/Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥11MPa | 15-18/Pass |
| Physical properties (Before Aging) | Ultimate Elongation: ≥300% | 530-552/Pass | |
| Physical properties (After Aging) | Tensile Strength: ≥11MPa | 15-18/Pass | |
| Physical properties (After Aging) | Ultimate Elongation: ≥300% | 533-553/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 |
Study Information to Prove Acceptance Criteria
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Sample size used for the test set and the data provenance:
- For the Watertightness Test (ASTM D5151), the reported result states "0/125 leaks," implying a sample size of 125 gloves were tested.
- For other tests like physical dimensions (ASTM D5250), powder content (ASTM D6124), physical properties (ASTM D412), cytotoxicity (ISO 10993-5), irritation (ISO 10993-10), and sensitization (ISO 10993-10), the exact sample sizes are not explicitly stated in the provided summary. However, these tests would typically involve a statistically appropriate number of samples as defined by the respective ASTM and ISO standards.
- Data Provenance: The document does not explicitly state the country of origin of the test data or whether it was retrospective or prospective. Given that the manufacturer is "Inner Mongolia Cureguard Medical Materials Co., Ltd." in China, it is highly probable that the testing was conducted in China. These tests are inherently prospective as they are performed specifically to evaluate the manufactured device against established standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes non-clinical performance testing of a physical medical device (examination gloves). The "ground truth" for these tests is established by objective measurements and chemical/biological assays according to the specified ASTM and ISO standards, not by expert consensus or interpretation in the way one might assess an AI diagnostic algorithm. Therefore, the concept of "experts establishing ground truth" in the context of medical imaging or clinical diagnosis is not applicable here. The tests are performed by technicians following standard protocols.
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Adjudication method for the test set:
- Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. For the non-clinical, objective performance tests described, no adjudication method is relevant or mentioned. The results are quantitative measurements or pass/fail determinations based on predefined criteria in the standards.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This device is a disposable vinyl examination glove, and the testing focuses on its physical, chemical, and biological properties, not on diagnostic accuracy requiring human reader interpretation with or without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical examination glove, not an AI algorithm.
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The type of ground truth used:
- The "ground truth" for this device's performance is established by conformance to internationally recognized standards (ASTM D5250, D5151, D6124, D412, ISO 10993-5, ISO 10993-10). These standards define specific test methodologies and acceptance criteria based on objective measurement. For example, for watertightness, the ground truth is simply whether water leaks or not under specified conditions, as directly measured. For biocompatibility, it is the observed biological response to certain assays.
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The sample size for the training set:
- This concept is not applicable to the testing of a physical medical device like an examination glove. "Training set" refers to data used to train machine learning models. The tests performed are for product quality and safety validation, not model training.
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How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 7.
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June 16, 2021
Inner Mongolia Cureguard Medical Materials Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211336
Trade/Device Name: Disposable Vinyl Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 21, 2021 Received: May 3, 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,
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211336
Device Name Disposable Vinyl Examination Glove
Indications for Use (Describe)
The Disposable 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 (K211336)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Inner Mongolia Cureguard Medical Materials Co., Ltd. Address: RM 408, Building 5, Block B of Business Science & Technology Center, Jining District, Ulangab City, Inner Mongolia Autonomous Region. Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: 06/15/2021
Designated Submission Correspondent
Mr. Boyle Wanq 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 Vinyl Examination Glove Common name: Vinyl Patient Examination Glove Classification name: Non-powdered Patient Examination Glove XS,S, M, L, XL Model(s):
3.0_Classification
Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Hebei Hongtai Plastic Products Company Limited Manufacturer: Vinyl Patient Examination Gloves (White, Blue, Yellow) Device: 510(k) number: K163168
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5.0 Indication for Use
The Disposable 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 patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
7.0 Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject device | Predicate device | Comparison |
| 510(k) number | K211336 | K163168 | - |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable VinylExamination Glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hands toprevent contaminationbetween patient andexaminer. | The Vinyl ExaminationGlove (White, Blue, orYellow) is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| LabelingInformation | Single use, powder free,device color, devicename, glove size andquantity, VinylExamination Gloves,Non-Sterile | Single use, powder free,device color, devicename, glove size andquantity, VinylExamination Gloves,Non-Sterile | Similar |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate Device(K163168) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| Length, mm | 230 | 230 | 235 | 245 | 245 | min | |
| Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm$ 5 |
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| Thickness, mm: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Finger | 0.05 | min | ||||||
| Palm | 0.08 | min | ||||||
| Subject Device(K211336) | 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 | 0.08 | min | ||||||
| Palm | 0.08 | min | ||||||
| Remark | Similar |
Analysis: The physical dimensions are little different with that of the predicate, but they all meet the requirements of ASTM D5250.
| Item | Subject device(K211336) | Predicate device(K163168) | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Clear | White, Blue,Yellow | Analysis 1 | ||
| PhysicalProperties | BeforeAging | TensileStrength | 11MPa, min | 15MPa, min | Analysis 2 |
| UltimateElongation | 300%min | 380%min | Analysis 2 | ||
| AfterAging | TensileStrength | 11MPa, min | 15MPa, min | Analysis 2 | |
| UltimateElongation | 300%min | 380%min | Analysis 2 | ||
| Comply with ASTM D5250 | Comply withASTM D5250 | Comply withASTM D5250 | Same | ||
| Freedom from Holes | Be free from holes whentested in accordance withASTM D5151AQL=2.5 | Be free from holeswhen tested inaccordance withASTM D5151AQL=2.5 | Same | ||
| Powder Content | < 0.01 mg perglove. Meet therequirements ofASTM D6124 | Meet therequirements ofASTM D6124 | Similar |
Table3 Performance Comparison
Analysis 1: The colorant of the subject device is different with that of the predicate device, the subject device was evaluated according to ISO 10993-1 standards.
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.
| Item | Subject device | Predicated device | Comparison | |
|---|---|---|---|---|
| Material | Vinyl | Vinyl | Same | |
| Biocompatibility | Irritation | Comply withISO10993-10.Under theconditions of thestudy, not an irritant | Comply withISO10993-10 | Same |
| Sensitization | Comply withISO10993-10.Under conditions ofthe study, not asensitizer. | Comply withISO10993-10 | ||
| Cytotoxicity | Comply withISO10993-10.Under conditions ofthe study, did notshow potentialtoxicity to L-929cells. | Not provided | Different | |
| Label and Labeling | Meet FDA'sRequirement | Meet FDA'sRequirement | Same |
Table4 Safety Comparison
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
ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
| 1 นิพิธ 9 อัลบที่เป็นที่ 7 ปี ที่มีเปิดที่มีเพื่อปี พ.ศ. 1911 เมื่อไปปี พ.ศ. 1981 เมื่ | ||||||||
|---|---|---|---|---|---|---|---|---|
| Test Methodology | Purpose | Acceptance Criteria | Results | |||||
| 4 of page 6 | ||||||||
| ASTM D5250 | PhysicalDimensions Test | Length(mm):≥230; | Length: ≥230/ Pass | |||||
| Width(mm): | Width: | |||||||
| XS:75±5; | XS: 74-77/ Pass | |||||||
| S: 85±5; | S: 83-87 /Pass | |||||||
| M: 95±5; | M: 96-97/ Pass | |||||||
| L: 105±5; | L: 104-108/ Pass | |||||||
| XL: 115±5; | XL: 114-117/ Pass | |||||||
| Thickness (mm) :Finger: ≥0.08Palm: ≥0.08 | Finger: 0.09-0.14/PassPalm: 0.10-0.13/Pass | |||||||
| ASTM D5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTMD5151 AQL 1.5 | 0/125 leaks / Pass | |||||
| ASTM D6124 | Powder Content | Meet the requirements of ASTMD6124 < 2.0mg | 0.01 mg/Pass | |||||
| ASTM D412 | Physicalproperties | Before | TensileStrength | ≥11MPa | 15-18/Pass | |||
| Aging | UltimateElongation | ≥300% | 530-552/Pass | |||||
| After | TensileStrength | ≥11MPa | 15-18/Pass | |||||
| Aging | UltimateElongation | ≥300% | 533-553/Pass | |||||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions ofthe study, did notshow potential toxicityto L-929 cells./ Pass | |||||
| ISO 10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant/ Pass | |||||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer / Pass |
Table 5 Summary of non-clinical performance testing
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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 proposed device, Disposable Vinyl Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K163168.
§ 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.