(114 days)
High Risk Latex Examination Gloves, Powder Free Non Sterile is a disposable device and made of natural rubber latex for medical purpose that is worn on the examiner's hand or finger to prevent conta mination between patient and examiner.
HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE is a disposable device and made of natural rubber latex.
This document is about the FDA's 510(k) premarket notification for "High Risk Latex Examination Gloves, Powder Free, Non Sterile". It's a regulatory clearance document, not a study report for a novel medical device with AI components. Therefore, much of the information requested in the prompt (e.g., acceptance criteria for an algorithm, sample sizes for training/test sets, expert qualifications, MRMC studies) is not applicable or present in this type of document.
However, I can extract the relevant information about the "device" in question (gloves) and its regulatory classification.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for gloves) | Reported Device Performance (implied by FDA clearance) |
|---|---|
| Substantially equivalent to legally marketed predicate devices | Passed FDA's 510(k) review for substantial equivalence |
| Meets general controls and provisions of the Federal Food, Drug, and Cosmetic Act (Act) | Complies with general controls (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) |
| Intended purpose: prevent contamination between patient and examiner | Suitable for medical purpose, worn on examiner's hand/finger to prevent contamination |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not detail specific testing protocols or sample sizes for performance evaluation in the context of an AI/algorithm-driven device. For gloves, testing typically involves standards related to physical properties (e.g., tensile strength, barrier integrity, dimensions) and biocompatibility, but the specifics are not in this FDA letter. The device manufacturer (Pt. Mahakarya Inti Buana) is from Sumut, Indonesia.
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)
- Not applicable / Not provided. This information is for evaluating AI or diagnostic device performance, not for gloves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. This pertains to expert review in AI studies.
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 / Not provided. This is relevant for diagnostic devices that involve human interpretation assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. There is no algorithm described for this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The "ground truth" for gloves would relate to their physical and biological properties meeting established standards (e.g., ASTM standards for medical gloves) and regulatory requirements, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
- Not applicable / Not provided. There is no AI model or "training set" for this device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. There is no AI model or "training set" for this device.
In summary, the provided document is a regulatory clearance for medical gloves, which are a physical product, not a software or AI-driven diagnostic device. Therefore, the specific questions regarding AI device performance evaluation, expert reviews, and data sets for algorithms are not relevant to this document.
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NOV 3 U 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pt. Mahakarya Inti Buana Mr. V. Nadarajan Manager, Quality Assurance/Regulatory Affairs Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa-20362 SUMUT-INDONESIA
Re: K062313
Trade/Device Name: High Risk Latex Examination Gloves, Powder Free, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 13, 2006 Received: November 16, 2006
Dear Mr. Nadarajan:
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. Nadarajan
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
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Indications for Use
510(k) Number (if known): KOGQ313
Device Name: HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE
Indications For Use: High Risk Latex Examination Gloves, Powder Free Non Sterile is a disposable device and made of natural rubber latex for medical purpose that is worn on the examiner's hand or finger to prevent conta mination 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)
Shulie A. Murphy, M.D.
. of Anesthesiology, General Hospita n Control, Dental Devices
K 062313
Page 1 of 1
§ 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.