(42 days)
Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
This document is a 510(k) clearance letter from the FDA for a medical device: "Synthetic Vinyl Medical Examination Powder Free Glove" manufactured by Top Glove Sdn. Bhd. It concerns regulatory clearance for marketing the device, not a study report or acceptance criteria for a specific performance characteristic of the glove itself (e.g., tear resistance, sterility, absence of holes).
Therefore, based on the provided document, I cannot answer the questions about acceptance criteria and a study proving the device meets those criteria. The letter addresses the device's substantial equivalence to a predicate device, allowing it to be marketed, rather than presenting a performance study.
Here's why each specific point cannot be addressed from the given text:
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A table of acceptance criteria and the reported device performance: This document does not contain any performance acceptance criteria or reported device performance data for the gloves (e.g., tensile strength, puncture resistance, barrier integrity). It's a regulatory clearance, not a test report.
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Sample sized used for the test set and the data provenance: Not applicable, as no performance test data or test set is presented.
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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, as no performance test data or ground truth establishment is discussed.
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Adjudication method for the test set: Not applicable, as no performance test data or adjudication is discussed.
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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 document is for medical examination gloves and does not involve AI or human readers for diagnostic purposes.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a physical glove, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as ground truth is relevant for diagnostic or AI performance studies, which this is not.
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The sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable, as this is a physical medical device, not an AI algorithm.
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Image /page/0/Picture/1 description: The image is a black and white 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, often used as a symbol of medicine. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 1999
Mr. Loo Sun Nooi Assistant QA Manager Top Glove Sdn. Bhd. Lot 4968 Jalan Teratai Batu 6 Off Jalan Meru 41050 Klang, Selangor D.E., Malaysia
Re: K993680 Synthetic Vinyl Medical Examination Powder Trade Name: Free Gloves Requlatory Class: I Product Code: LYZ November 23, 1999 Dated: November 29, 1999 Received:
Dear Mr. Nooi:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ಕ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Nooi
obligation you might have under sections 531 through 542 of obligation you might have ahaor betronic Product Radiation the Act for devices ander on Federal laws or regulations.
This letter will allow you to begin marketing your device as This icecci will arenarket notification. The FDA described in your 510 (i) p=umance of your device to a legally Finding of Subscancial Oquination a classification for your marketed predicate device rubablice to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulacion (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriated as (od advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation encreased, "histian" (1) Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the Division of 638-2044 or (301) 443-6597 or at at its coll-free namber (05)/www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timoth Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.0 Ludications for Use Statement: Include the following or equivalent Indications for Use page. The Information, data and labeling claims in the cultie the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: ___________________________________________________________________________________________________________________________________________________________________ | TOP GLOVE SDN. BHD. | |||||
|---|---|---|---|---|---|---|
| 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | 993680 | |||||
| Device Name: _________________________________________________________________________________________________________________________________________________________________ | SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE |
Indications For Use:
Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
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Over-Ilo-Counter
(Optional Pormal 1-
- For a new submission, do NOT fill in the 510(k) number blank.
§ 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.