(38 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
Based on the provided text, the device in question is "Disposable Powder Free Vinyl Synthetic Exam Gloves." The document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a detailed study with specific acceptance criteria and performance metrics typically found for more complex medical devices like AI algorithms.
Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria cannot be directly extracted from this document, as it doesn't pertain to an AI/software device. However, I can infer some "acceptance criteria" from the nature of the device and the FDA's declaration of substantial equivalence.
Here's an attempt to answer the questions based on the available information and general understanding of medical device regulation for such products:
1. A table of acceptance criteria and the reported device performance
Since this is a Class I device (Patient Examination Glove), the "acceptance criteria" are implied by the regulatory framework for patient examination gloves and the predicate device. These typically relate to physical properties and barrier integrity. The document does not provide specific numerical performance metrics from a study.
| Acceptance Criteria (Inferred from regulatory standards for patient examination gloves) | Reported Device Performance (Implied by FDA's Substantial Equivalence) |
|---|---|
| Meets ASTM D5250 (Standard Specification for Poly(Vinyl Chloride) Gloves for Medical Application) standards for: | The device is substantially equivalent to legally marketed predicate devices, implying it meets the necessary performance standards for patient examination gloves. Specific numerical performance data is not provided in this document. |
| - Tensile Strength | |
| - Elongation at Break | |
| - Freedom from holes/Barrier integrity (e.g., AQL for pinholes) | |
| - Dimensions (length, palm width, thickness) | |
| - Powder-free requirements | |
| - Biocompatibility (cytotoxicity, dermal sensitization, irritation) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document does not specify a sample size for a test set or data provenance for a study. For a glove, testing typically involves batches of gloves to ensure quality and compliance with standards. It would be prospective testing on manufactured products.
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)
This is not applicable to this type of device. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic devices interpreting medical images or data. For a patient examination glove, "ground truth" relates to physical and material property measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is for diagnostic interpretation, not for evaluating the physical properties of a glove.
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 concept is for diagnostic AI devices, not for patient examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This concept is for AI algorithms, not for patient examination gloves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For patient examination gloves, the "ground truth" for performance would be based on objective physical and chemical tests conducted in laboratories (e.g., tensile testing machines, water leak test for pinholes, chemical analysis for leachables).
8. The sample size for the training set
Not applicable to this type of device and submission. This is relevant for machine learning models.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI model for this device. The manufacturing process and quality control would be based on established material science and engineering principles for glove production.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and a bowl, representing health and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Elite International Incorporated C/O Mr. Booby Ling 18709 Greenbay Drive Rowland Heights, California 91748
Re: K032616
Trade/Device Name: Disposable Powder Free Vinyl Synthetic Exam Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 30, 2003 Received: August 25, 2003
Dear Mr. Ling:
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. Ling
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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Suser Rinne
Susan Runner, DDS, MA Interim 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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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
ELITE INTERNATIONAL INC. Applicant:
510(k) Number (if known):
DISPOSABLE POWDER FREE VINYL SYNTHETIC Device Name: EXAM GLOVES
Indications For Use:
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Qian S. Lin
on Control Den
510(k) Number. K032616
- For a new submission, do NOT fill in the 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.