(70 days)
A powderfree patient examination glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Sunmax Blue Nitrile Powderfree Examination Glove
This document is a 510(k) premarket notification from Sunmax Enterprises Shanghai Company Limited for their Sunmax Blue Nitrile Powder Free Examination Glove. The FDA has found the device substantially equivalent to legally marketed predicate devices.
The document does not detail specific acceptance criteria or a study that proves the device meets those criteria in the way envisioned by the request. Instead, it indicates that the device has been deemed "substantially equivalent" to predicate devices already on the market. In the context of a 510(k) submission for this type of medical device (examination gloves), substantial equivalence is typically established by demonstrating that the new device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that it does not raise new questions of safety and effectiveness and is as safe and effective as the predicate.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment, which are common for higher-risk devices or more complex software/AI-based medical devices, are not explicitly present or applicable in this 510(k) for an examination glove.
However, based on general FDA requirements for examination gloves and the information provided, we can infer some aspects:
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A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of acceptance criteria for performance like accuracy, sensitivity, or specificity. For examination gloves, acceptance criteria usually relate to physical properties and barrier integrity. These would typically include:Acceptance Criterion (Inferred) Reported Device Performance (Inferred) Barrier Integrity (e.g., AQL for pinholes) Passed (implied by substantial equivalence) Tensile Strength Met (implied by substantial equivalence) Elongation Met (implied by substantial equivalence) Dimensions Met (implied by substantial equivalence) Biocompatibility (skin irritation, sensitization) Met (implied by substantial equivalence) Powder-free status Met (as per device name "Powder Free") The "reported device performance" is not explicitly stated but is implied to meet the necessary standards for substantial equivalence to a predicate device.
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Sample size used for the test set and the data provenance: There is no specific test set sample size or data provenance mentioned in this document. For gloves, testing is typically done on batches, and the FDA would evaluate manufacturing controls, not a clinical trial with a "test set" in the AI or diagnostic sense.
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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. For examination gloves, performance is assessed through standardized physical and chemical tests, not through expert-established ground truth on a test set.
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Adjudication method for the test set: Not applicable.
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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 an examination glove, not an AI or diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would be laboratory measurements and adherence to recognized standards (e.g., ASTM standards for medical gloves) and FDA guidance for physical properties, rather than diagnostic outcomes.
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The sample size for the training set: Not applicable. This is not a machine learning device.
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How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) letter confirms the regulatory clearance based on substantial equivalence, rather than detailing a specific performance study with acceptance criteria in the manner requested for complex diagnostic or AI devices. The information provided is typical for a Class I medical device like an examination glove.
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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three human figures.
AUG 1 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sunmax Enterprises Shanghai Company Limited C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
K011765 Re : Sunmax Blue Nitrile Powder Free Trade/Device Name: Examination Glove Regulation Number: 880.6250 Requlatory Class: I Product Code: LZA Dated: June 5, 2001 Received: June 7, 2001
Dear Ms. Falk:
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 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). 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 (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. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Ms. Falk
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Antone Ciceretti // for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SUNMAX ENTERRPISE SHANGHAI CO.,LTD
Image /page/2/Picture/1 description: The image shows a logo with a stylized handprint forming a circle. Inside the handprint, there are lines representing fingers. To the right of the handprint, there are three small circles arranged vertically. Below the handprint, the word "Maslaa" is written in a stylized font.
The Vangard of Vinyl Gloves
No.2 New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghal, China TEL: (886) 2 2713 6677 FAX: (886) 2 2546 2480
April 20'0. 2001
INDICATIONS FOR USE STATEMENT
of
510(k) Number (if known): KO 11765
Examination
Device Name Sunmax Blue Nitrile Powderfree Glove
Indications For Use:A powderfree patient examination glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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Alex Lee President SUNMAX ENTERPRISE SHANGHAI CO., LTD
(PLEASE OO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use (Optional Format 09 (Per 21 CFR 801.109)
Clins S. Lim
(Division Sign ! Division of D --- : Infection Control, and General Fiosp 510(k) Number
§ 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.