(79 days)
A patient examination Vinyl Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Vinyl Examination Gloves
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Table of Acceptance Criteria and Reported Device Performance:
Performance Metric Acceptance Criteria Reported Device Performance Substantial Equivalence The device is substantially equivalent to legally marketed predicate devices. The device (Powdered Vinyl Examination Gloves) is determined to be substantially equivalent to legally marketed predicate devices. Indications for Use Intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The device meets this indication for use. Classification Classified as Class I, subject to general controls. The device is classified as Class I. -
Sample Size for Test Set and Data Provenance:
- The provided document is a 510(k) clearance letter from the FDA, not a study report. Therefore, it does not specify a "test set" in the context of an algorithm or device performance study with a numerical sample size.
- The determination of substantial equivalence for devices like examination gloves typically relies on adherence to recognized standards and comparison to predicate devices, rather than a prospective study with a specific test set of patients or samples.
- Data Provenance: Not applicable in the context of an algorithmic test set. The review is based on the manufacturer's submission demonstrating equivalence to established predicate devices.
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Number of Experts and Qualifications:
- This document refers to the FDA's review process. The "experts" involved are the reviewers within the FDA's Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health.
- The letter is signed by Chiu Lin, Ph.D., Director of that division. While specific qualifications for all individual reviewers are not detailed, it is understood that FDA reviewers are subject matter experts in medical devices and regulatory science. There is no mention of a specific number of "experts" as would be in a consensus study.
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Adjudication Method:
- Not applicable in the context of a 510(k) clearance. Substantial equivalence is determined by the FDA based on the submitted information comparing the new device to predicates, not through an adjudication process with multiple readers or experts assessing a test set.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done, as this document is a 510(k) clearance for a physical device (examination gloves), not an AI algorithm. Therefore, there is no discussion of human readers improving with or without AI assistance.
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Standalone Performance Study (Algorithm Only):
- No, a standalone performance study was not done because this is not an AI algorithm. It is a physical device subject to general controls and substantial equivalence review.
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Type of Ground Truth Used:
- The "ground truth" for a 510(k) for a device like examination gloves is established through adherence to recognized performance standards (e.g., for strength, barrier integrity, biocompatibility) and comparison to existing, legally marketed predicate devices. The "ground truth" is that the device performs as safely and effectively as its predicates for its intended use. There isn't a "ground truth" in the sense of expert consensus, pathology, or outcomes data for this type of submission.
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Sample Size for the Training Set:
- Not applicable. There is no AI algorithm being "trained" for this device. The concept of a training set is not relevant to the 510(k) clearance of examination gloves.
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How Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device type.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2006
Mr. Wu Kin Yeap General Manager TG Medical (China) Incorporated 3. Xitang Road, Xizhang Town Zhangjiagang, Jiangsu Province 215614 CHINA
Re: K052984
Trade/Device Name: Powdered Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 5, 2005 Reccived: January 9, 2005
Dear Mr. Yeap:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Yeap
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); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Sincercly vours,
Qur
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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Indications for Use
510(k) Number (if known): K052984
Device Name: Powdered Vinyl Examination Gloves
Indications For Use:
A patient examination Vinyl Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) , ",
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evelyn Murphy, KS 1/1/04
General Hospital,
Services
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§ 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.