(90 days)
A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Blue Powder Free Examination Glove
Here's an analysis of the provided FDA document regarding the acceptance criteria and study details for the Nitrile Blue Powder Free Examination Glove:
This document is a 510(k) clearance letter for a medical device (Nitrile Blue Powder Free Examination Glove). It does not contain the acceptance criteria or results of a study designed to prove the device meets specific performance criteria, especially not in the context of an AI/ML powered device.
Instead, this document is a regulatory approval letter stating that the device is "substantially equivalent" to a legally marketed predicate device. This means the manufacturer demonstrated that their device performs similarly to an existing device for its intended use, rather than conducting a de novo study against a set of predefined acceptance criteria for novel performance claims.
Therefore, I cannot provide the requested information from the provided text. The questions you've asked are typically relevant for AI/ML device submissions, which involve rigorous testing against performance metrics. This document pertains to a Class I medical device for which the primary regulatory pathway is demonstrating substantial equivalence.
However, to illustrate what specific elements are missing and why the provided document does not fulfill the request, let's address each point as if this were an AI/ML device submission, explaining why the information is absent:
1. A table of acceptance criteria and the reported device performance
- Missing: This document does not specify any quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1 score, AUC) or corresponding acceptance criteria needed for an AI/ML device. For a glove, the "performance" would relate to barrier integrity, tensile strength, and freedom from holes, but these types of metrics are not detailed here.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing: No test set is described, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm.
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)
- Missing: Not applicable for this type of device and submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Missing: Not applicable.
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
- Missing: Not applicable. This device is not an AI algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing: Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing: Not applicable. For a glove, "ground truth" might relate to physical properties meeting standards, but this is not detailed.
8. The sample size for the training set
- Missing: Not applicable. There is no training set for a physical device like a glove.
9. How the ground truth for the training set was established
- Missing: Not applicable.
Conclusion:
The provided FDA letter (K071208) is a clearance for a Nitrile Blue Powder Free Examination Glove based on substantial equivalence. It does not contain the detailed performance metrics, study designs, or data provenance information that would be requested for an AI/ML device's acceptance criteria and validation study. The letter confirms market clearance, but not specific test results or acceptance criteria in the manner you've outlined for software/algorithm performance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2007
Mr. Hue Kon Fah Deputy General Manager High Momentum Sdn. Bhd. No. 12, Lorong Batu Nilam 6A Bandar Bukit Tinggi Klang 42100 Pelabuhan Klang Selangor Darul Ehsan MALAYSIA
Re: K071208
Trade/Device Name: Nitrile Blue Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 14, 2007 Received: July 23, 2007
Dear Mr. Fah:
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. Fah
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 (OS) 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.
Sincerely yours,
Suditte y. Michaud
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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INDICATION FOR USE
510 (k) Number (if known) :
Nitrile Blue Powder Free Examination Glove Device Name :
Indication For Use :
A patient examination Nitrile Blue Powder Free 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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Shel. N. Murphy, RPh
(Division Sign-Off)
Division of Anesthesiology, General Hospilletence of CDRH, Office of Device Evaluation (ODE) Infection Control, Dental Devices
510(k) Number: K071208
8-10
§ 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.