(39 days)
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Powder-Free Synthetic Vinyl Exam Gloves with Vitamin E coating
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, based on the information available:
Device: Powder-Free Synthetic Vinyl Exam Gloves With Vitamin E Coating
Acceptance Criteria and Device Performance:
The provided document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a legally marketed predicate device. For this type of device (patient examination gloves), the primary acceptance criteria revolve around performance standards related to integrity (preventing contamination) and biocompatibility, rather than diagnostic accuracy or specific clinical outcomes often seen with AI/clinical decision support devices.
While the document doesn't explicitly list a table of acceptance criteria with reported device performance, it implies that the device has met the necessary standards for patient examination gloves to be deemed substantially equivalent. Key aspects for such gloves typically include:
- Barrier Protection (Freedom from Holes): Measured by acceptable quality levels (AQL) from water leak tests.
- Physical Properties: Tensile strength, elongation, etc., to ensure durability during use.
- Biocompatibility: Absence of adverse reactions upon skin contact.
- Powder-Free Status: Compliance with industry standards for powder residue.
- Vitamin E Coating Specificity: Given the "With Vitamin E Coating" in the name, there would likely be requirements or characterization related to the presence and safety of this coating, potentially contributing to skin conditioning or reducing irritation. The FDA's acceptance suggests these aspects were found to be compliant.
Since no specific study results or performance metrics are detailed in the provided text, the table below reflects what would typically be expected for this type of device to meet FDA acceptance for 510(k) clearance, rather than explicitly stated metrics from the document.
| Acceptance Criteria (Typical for Exam Gloves) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Freedom from holes (e.g., AQL 2.5 for critical defects) | Meets or exceeds industry standard for barrier integrity |
| Tensile Strength (e.g., Min 14 MPa) | Meets or exceeds industry standard for physical durability |
| Elongation at Break (e.g., Min 300%) | Meets or exceeds industry standard for flexibility |
| Biocompatibility (e.g., primary skin irritation, dermal sensitization) | Biocompatible with skin contact |
| Powder Residue (e.g., Max 2 mg per glove) | Meets industry standard for powder-free classification |
| Vitamin E Coating Presence/Safety | Present and safe for intended use |
Other Requested Information based on the provided document:
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Sample size used for the test set and the data provenance: The document does not provide details about sample sizes for testing or data provenance (e.g., country of origin, retrospective/prospective). This information would typically be in the 510(k) submission itself, not the FDA clearance letter.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. For patient examination gloves, "ground truth" typically refers to objective material and performance standards, not expert clinical interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or provided. Adjudication methods are relevant for subjective assessments, typically in diagnostic or screening device studies.
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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 device is a medical glove, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical glove, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" would be established by objective engineering standards and laboratory test results (e.g., water leak test for pinholes, tensile strength measurements, biocompatibility assays) rather than expert consensus, pathology, or outcomes data.
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The sample size for the training set: Not applicable. This device does not involve machine learning or a "training set."
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
Conclusion from the Document:
The provided FDA letter (K051683) indicates that Shen Wei (USA), Incorporated's Powder-Free Synthetic Vinyl Exam Gloves With Vitamin E Coating has been found substantially equivalent to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a device already on the market, based on the information provided in the 510(k) submission, implied to include sufficient testing against established performance standards for patient examination gloves. The letter itself does not contain the detailed study results or specific acceptance criteria, but rather the regulatory outcome of their review.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in all capital letters. The logo is simple and uses a black and white color scheme.
Public Health Service
AUG 1 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shen Wei (USA), Incorporated c/o Mr. Stanley Duan 33278 Central Avenue, #102 Union City, California 94587
Re: K051683
Trade/Device Name: Powder-Free Synthetic Vinyl Exam Gloves With Vitamin E Coating Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: May 21, 2005 Received: June 23, 2005
Dear Mr. Duan:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Duan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with the word "Wei" in bold, black letters. Above the word "Wei" is a graphic of what appears to be a tree. To the right of "Wei" is the text "usa inc."
Shen Wei (USA) Inc. 33278 Central Ave. #102. Union City, CA 94587 Tel: 510-429-8692 Fox: 510-487-5347
Attachment Two
INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
Powder-Free Synthetic Vinyl Exam Gloves with Vitamin E coating Device Name:
Indication for Use:
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Prescription Use (Per 21CFR 801 Subpart D) AND/OR
Over the Counter Y (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number. K051683
§ 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.