(62 days)
Vinyl Co-Polymer Powder-free Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Vinyl Co-Polymer Powder-free Examination Gloves, Black are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Vinyl Examination Gloves for Medical Application.
The provided text is related to the FDA 510(k) premarket notification for "Vinyl Co-Polymer Powder-free Examination Gloves, Black". This document describes the device's technical specifications and how it compares to a predicate device. It also includes non-clinical performance data to demonstrate that the device meets established standards.
However, the request asks for specific information regarding acceptance criteria and a study proving a medical device meets those criteria, particularly in the context of AI/ML-assisted diagnostic tools (implied by questions about MRMC studies, human readers, ground truth establishment for training/test sets, etc.). The provided document is for examination gloves, which are Class I medical devices and do not involve AI, image analysis, or diagnostic capabilities in the way the questions are framed. Therefore, most of the requested information is not applicable to this submission.
I will fill in the relevant information that is present in the document and explicitly state when the requested information is not applicable due to the nature of the device.
Here's the breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5250-19 | Length | Minimum 230mm | All size ≥230mm |
| ASTM D5250-19 | Palm Width (XS) | 75 ± 5 mm | 76-78mm |
| ASTM D5250-19 | Palm Width (S) | 85 ± 5 mm | 86-88mm |
| ASTM D5250-19 | Palm Width (M) | 95 ± 5 mm | 96-98mm |
| ASTM D5250-19 | Palm Width (L) | 105 ± 5 mm | 106-108mm |
| ASTM D5250-19 | Palm Width (XL) | 115 ± 5 mm | 116-118mm |
| ASTM D5250-19 | Thickness (Finger) | 0.08mm (min) | 0.08mm |
| ASTM D5250-19 | Thickness (Palm) | 0.08mm (min) | 0.08-0.10mm |
| ASTM D5250-19, ASTM D412-16 | Tensile Strength, Before Aging | 11MPa, min | 13.5-17.8 MPa |
| ASTM D5250-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 11MPa, min | 13.1-17.6 MPa |
| ASTM D5250-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 300%, min | 320-430% |
| ASTM D5250-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 300%, min | 310-420% |
| ASTM D5151-19, ASTM D65250-19 | Freedom from holes | G-I, AQL 2.5 | Meets AQL 2.5 requirements |
| ASTM D6124-06(2017), ASTM D5250-19 | Powder-Content | ≤2 mg per glove | 0.35-0.68 mg |
| 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| 10993-10:2010 | Maximization Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| 10993-5:2009 | In Vitro Cytotoxicity Test | No potential cytotoxicity to L929 cells | No potential cytotoxicity to L929 cells |
| ISO 10993 Part 11 | Acute Systemic Toxicity Test | No systemic toxicity | No systemic toxicity |
2. Sample sizes used for the test set and the data provenance
The document refers to "non-clinical tests" and "performance test data" but does not specify the exact sample sizes (e.g., number of gloves tested for each individual parameter). The tests conducted are standard physical and biocompatibility tests for examination gloves as per ASTM and ISO standards.
- Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the specifications of the referenced ASTM and ISO standards.
- Data Provenance: The manufacturing entity is Grand Work Plastic Products Co., Ltd in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing was presumably conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but for device development and regulatory submission, it would reflect tests performed on batches of the device.
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)
Not applicable. This device is an examination glove, not an AI/ML-based diagnostic system that requires expert interpretation for ground truth establishment. The "ground truth" for these tests is based on objective physical, chemical, and biological measurements against established international standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic system requiring expert adjudication of results. Testing is based on laboratory measurements and adherence to specified tolerances.
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 an examination glove and does not involve human readers, AI assistance, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an examination glove and does not involve algorithms or standalone performance testing in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on:
- Physical and Mechanical Standards: Measurements of length, palm width, thickness, tensile strength, and elongation against specifications in ASTM D5250-19 and ASTM D412-16.
- Performance Standards: Freedom from holes (ASTM D5151-19, ASTM D65250-19) and powder content (ASTM D6124-06(2017), ASTM D5250-19).
- Biocompatibility Standards: Results from tests for skin irritation, sensitization (ISO 10993-10:2010), in vitro cytotoxicity (ISO 10993-5:2009), and acute systemic toxicity (ISO 10993 Part 11).
8. The sample size for the training set
Not applicable. This device is an examination glove and does not involve AI/ML models that require training sets.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, no ground truth establishment method for a training set is relevant.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2022
Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K220240
Trade/Device Name: Vinyl Co-Polymer Powder-free Examination Gloves, Black Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: January 25, 2022 Received: January 28, 2022
Dear Kathy Liu:
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) K220240
Device Name
Vinyl Co-Polymer Powder-free Examination Gloves, Black
Indications for Use (Describe)
Vinyl Co-Polymer Powder-free Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand 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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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Vinyl Co-Polymer Powder-free Examination Gloves, Black
510(K) SUMMARY
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K220240 Date Prepared: March 24, 2022
1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611
2. Name of the Device:
Trade Name: Vinyl Co-Polymer Powder-free Examination Gloves, Black Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LYZ Device Class: Class I
3. Predicate Device Information:
Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder-free Examination Gloves, Blue color - (K142409)
4. Device Description:
Vinyl Co-Polymer Powder-free Examination Gloves, Black are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Vinyl Examination Gloves for Medical Application.
5. Intended Use of the Device:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Comparison of Subject Device and Predicate Device:
The subject device will be known as Vinyl Co-Polymer Powder-free Examination Gloves, Black.
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Vinyl Co-Polymer Powder-free Examination Gloves, Black
The following tables are a comparison of the technological characteristics, biocompatibility of the subject and predicate devices.
General Comparison Table:
| # | Subject Device(K220240) | Predicate Device(K142409) | Comparison |
|---|---|---|---|
| Trade Name | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Vinyl Co-Polymer Powder-free Examination Gloves, Blue color | Similar |
| Product Code | LYZ | LYZ | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Proposed Device is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Predicate device is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Materials | vinyl and oil-based liquid nitrile rubber | vinyl and oil-based liquid nitrile rubber | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Black | Blue | Different |
| Single use | Single use | Single use | Same |
Dimensions and Performance Comparison Table:
| TechnologicalCharacteristics | Subject Device(K220240) | Predicate Device(K142409) | Comparison |
|---|---|---|---|
| Length | Minimum 230mm for allsizes | Minimum 230mm forall sizes | Same |
| Palm Width (size) (mm) | |||
| XS | $75\pm5$ | Not Applicable | Different |
| S | $85\pm5$ | $85\pm5$ | Same |
| M | $95\pm5$ | $95\pm5$ | Same |
| L | $105\pm5$ | $105\pm5$ | Same |
| XL | $115\pm5$ | $115\pm5$ | Same |
| Thickness(mm) | |||
| Finger | Minimum 0.08 | Minimum 0.05 | Different |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| Palm | Minimum 0.08 | Minimum 0.08 | Same |
|---|---|---|---|
| Tensile Strength, BeforeAging | 11MPa, min | 11MPa, min | Same |
| UltimateElongation, BeforeAging | 300%, min | 300%, min | Same |
| Tensile Strength, AfterAccelerated Aging | 11MPa, min | 11MPa, min | Same |
| Ultimate Elongation,After AcceleratedAging | 300%, min | 300%, min | Same |
| Freedom from holes | G-I, AQL 2.5 | G-I, AQL 2.5 | Same |
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | Same |
| 10993-10:2010 SkinIrritation Study | Under the conditions ofthe study, not an irritant | Under the conditions ofthe study, not an irritant | Same |
| 10993-10:2010MaximizationSensitization Study | Under the conditions ofthe study, not a sensitizer | Under the conditions ofthe study, not a sensitizer | Same |
| 10993-5:2009 In VitroCytotoxicity Test | Under the conditions of thisstudy, the test article extractshowed no potentialcytotoxicity to L929 cells. | / | Different |
| ISO 10993 Part 11Acute Systemic ToxicityTest | It is concluded that theextracts (polar and non-polar) of the product did notshow any systemic toxicity | / | Different |
Product: Vinyl Co-Polymer Powder-free Examination Gloves, Black
There are no significant differences between the two products and are identical in terms of intended use and have similar materials, design, and manufacturing methods.
7. Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards. The performance test data of the non-clinical tests for this glove are summarized below.
| Test method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5250- 19 | Length | Minimum 230mm | All size ≥230 |
| ASTM D5250- 19 | Palm Width | XS: $75\pm5$ mm | XS: 76-78mm |
| S: $85\pm5$ mm | S: 86-88mm | ||
| M: $95\pm5$ mm | M:96-98mm | ||
| L: $105\pm5$ mm | L:106-108mm | ||
| XL: $115\pm5$ mm | XL: 116-118mm |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| ASTM D5250- 19 | Thickness | Finger: 0.08mm (min) | 0.08mm |
|---|---|---|---|
| Palm: 0.08mm (min) | 0.08-0.10mm | ||
| ASTM D5250-19ASTN D412-16 | Tensile Strength, BeforeAging | 11MPa, min | 13.5-17.8 MPa |
| ASTM D5250-19ASTN D412-16 | Tensile Strength, AfterAccelerated Aging | 11MPa, min | 13.1-17.6 MPa |
| ASTM D5250-19ASTN D412-16 | Ultimate Elongation, BeforeAging | 300%, min | 320-430% |
| ASTM D5250-19ASTN D412-16 | Ultimate Elongation, AfterAccelerated Aging | 300%, min | 310-420% |
| ASTM D 5151-19ASTM D65250- 19 | Freedom from holes | G-I, AQL 2.5 | Meets AQL2.5requirements |
| ASTM D 6124-06(2017)ASTM D5250 19 | Powder-Content | ≤2 mg per glove | 0.35-0.68 mg |
Product: Vinyl Co-Polymer Powder-free Examination Gloves, Black
8. Clinical Performance Data
No Clinical study is included in this submission.
9. 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 predicate device K142409.
§ 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.