(95 days)
The Disposable Vinyl Examination Gloves are 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, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text describes the acceptance criteria and a study for Disposable Vinyl Examination Gloves. It is a 510(k) summary for a medical device seeking substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Physical Properties | ||
| Tensile Strength (Before Aging) | 11 MPa, min (per ASTM D5250) | Meets 11 MPa, min |
| Ultimate Elongation (Before Aging) | 300% min (per ASTM D5250) | Meets 300% min |
| Tensile Strength (After Aging) | 11 MPa, min (per ASTM D5250) | Meets 11 MPa, min |
| Ultimate Elongation (After Aging) | 300% min (per ASTM D5250) | Meets 300% min |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Meets the requirements (AQL=2.5) |
| Powder Content | <0.04 mg per glove (Meets the requirements of ASTM D6124) | Meets the requirements (<0.04 mg per glove) |
| Dimensions | ||
| Length (XS, S, M, L, XL) | 220mm (XS, S), 230mm (M, L, XL) min (Tolerance specified: min) | 220mm (XS, S), 230mm (M, L, XL) min |
| Width (XS, S, M, L, XL) | 70mm (XS), 80mm (S), 90mm (M), 100mm (L), 110mm (XL) (Tolerance: ±5) | 70mm (XS), 80mm (S), 90mm (M), 100mm (L), 110mm (XL) |
| Finger Thickness | 0.05 mm min | 0.05 mm min |
| Palm Thickness | 0.08 mm min | 0.08 mm min |
| Biocompatibility | ||
| Irritation | Not an irritant (Compliant with ISO 10993-10) | Under the conditions of the study, not an irritant. Complies with ISO 10993-10. |
| Sensitization | Not a sensitizer (Compliant with ISO 10993-10) | Under conditions of the study, not a sensitizer. Complies with ISO 10993-10. |
| Cytotoxicity | No potential toxicity to L-929 cells (Compliant with ISO 10993-5) | Under conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5. |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for Freedom from Holes or how many samples for Biocompatibility). It refers to compliance with standards like ASTM D5151, ASTM D6124, ISO 10993-10, and ISO 10993-5, which would have their own specified sampling plans.
The manufacturer is Shandong Zhushi Pharmaceutical Group Co., Ltd located in Shandong, China. The tests were conducted to demonstrate compliance with international standards, but specific data provenance within China is not detailed. The tests are non-clinical and would be considered prospective as they were performed to verify that the proposed device met design specifications before market approval.
3. 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)
This is not applicable as the device is a vinyl examination glove and the "ground truth" is established through adherence to recognized international and national standards for physical properties, chemical properties, and biocompatibility, not by expert consensus on interpretations of medical images or complex diagnostic assessments. The "ground truth" is objective measurement against specified criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in subjective assessments like medical image interpretation. For a physical medical device like gloves, the assessment is based on objective measurements and compliance with established standards, not expert adjudication.
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 device is a disposable vinyl examination glove, not an AI-powered diagnostic tool. MRMC studies are used for evaluating the effectiveness of AI in assisting human readers in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the acceptance criteria is defined by recognized international and national standards (e.g., ASTM D5250 for physical properties, ASTM D5151 for freedom from holes, ASTM D6124 for powder content, and ISO 10993-5/10 for biocompatibility). Test results are compared directly against the specifications outlined in these standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for such a device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical device, this question is irrelevant.
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Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2021
Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608, No.738,Shangcheng Rd., Pudong Shanghai, 200120 China
Re: K203439
Trade/Device Name: Disposable 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 5, 2020 Received: November 23, 2020
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 (OS) 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 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203439
Device Name Disposable Vinyl Examination Gloves
Indications for Use (Describe)
The Disposable Vinyl Examination Gloves are 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 (K203439)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Shandong Zhushi Pharmaceutical Group Co., Ltd Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Phone Number: +86-15764021131 Contact: Junhui Zhu Date of Preparation: 03/11/2020
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 Vinyl Examination Gloves Common name: Non-powdered Patient Examination Glove Classification name: Vinyl Patient Examination Glove Model(s): XS, 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: Hebei Hongtai Plastic Products Company Limited Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 510(k) number: K163168
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5.0 Indication for Use
The Disposable Vinyl Examination Gloves are intended for medical purposes that is worn on the examiners 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, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
7.0 Technological Characteristics
| Item | Subject device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K203439 | K163168 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | / | / | Same |
| Intended Use | The Disposable VinylExamination Gloves are 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 thatis worn on theexaminer's hands toprevent contaminationbetween patient andexaminer. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single use, powder free,device color, devicename, glove size andquantity, VinylExamination Gloves,Non-Sterile | Single use, powderfree, device color,device name, glove sizeand quantity, VinylExamination Gloves,Non-Sterile | Similar |
| Sterility | Non-Sterile | Non-Sterile | Same |
Table1-General Comparison
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| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K163168) | XS | S | M | L | XL | ||
| Length, mm | 230 | 230 | 235 | 245 | 245 | min | |
| Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Subject Device | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 90 | 100 | 110 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | SAME |
Table2 Device Dimensions Comparison
Table3 Performance Comparison
| Item | Subject device | Predicated device | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Clear, Non-Colored | White, Blue, Yellow | Analysis1 | ||
| PhysicalProperties | BeforeAging | Tensile Strength | 11MPa, min | 15MPa, min | Analysis2 |
| Ultimate Elongation | 300%min | 380%min | Analysis2 | ||
| AfterAging | Tensile Strength | 11MPa, min | 15MPa, min | Analysis2 | |
| Ultimate Elongation | 300%min | 380%min | Analysis2 | ||
| Comply with ASTM D5250 | Comply with ASTM D5250 | Comply with ASTM D5250 | SAME | ||
| Freedom from Holes | Be free from holes whentested in accordance withASTM D5151 AQL=2.5 | Be free from holes whentested in accordance withASTM D5151 AQL=2.5 | SAME | ||
| Powder Content | <0.04 mg per glove.Meets the requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | SIMILAR |
Analysis1: The subject device (colorless) has different color to the predicate device (White, Blue, Yellow), but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not affect the safety of proposed device.
Analysis2: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250, so the differences do not raise any new safety or performance questions.
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| Item | Subject device | Predicated device | Comparison | |
|---|---|---|---|---|
| Material | Vinyl | Vinyl | SAME | |
| Biocompatibility | Irritation | Under the conditions of thestudy, not an irritant.Complies with ISO 10993-10 | Comply withISO10993-10 | SAME |
| Sensitization | Under conditions of thestudy, not a sensitizer.Complies with ISO 10993-10 | SAME | ||
| Cytotoxicity | Under conditions of thestudy, did not show potentialtoxicity to L-929 cells.Complies with ISO 10993-5 | / | Different | |
| Label and Labeling | Meet FDA's Requirement | Meet FDA'sRequirement | SAME |
Table4 Safety Comparison
8.0 Discussion of non-clinical and clinical test performed
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
ASTMD5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-06, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
Clinical testing is not needed for this device.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
§ 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.