(49 days)
A 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.
On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)
The provided text is a 510(k) premarket notification approval letter for a medical device: "On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)".
This document is a regulatory approval and does not describe a study to prove the device meets acceptance criteria in the way envisioned by the request. The request asks for details about a study to evaluate "device performance" in terms of metrics like accuracy, effect size with AI assistance, and ground truth establishment, which are typical for diagnostic or AI-powered devices.
For a patient examination glove, the "acceptance criteria" and "study" would refer to manufacturing standards, chemical composition, biocompatibility, physical properties (e.g., tensile strength, elongation), and extractable protein content. The approval letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it meets the same safety and effectiveness standards.
Therefore, I cannot fulfill the request as formatted because the provided document does not contain the information required to populate the requested table and answer the study-specific questions. There is no information on:
- A table of acceptance criteria and reported device performance in the context of an accuracy study.
- Sample sizes for test sets, data provenance, or retrospective/prospective nature.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone performance of an algorithm.
- Type of ground truth used (e.g., pathology, outcomes).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory confirmation of substantial equivalence for a physical medical product, not a clinical or performance study report for a diagnostic or AI device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Perusahaan Getah Asas Sdn Bhd C/O Mr. James F. Logan Medical Reports Exchange 1301 Defence Highway Gambrills, Maryland 21054
Re: K030331
Trade/Device Name: On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 28, 2003 Received: January 31, 2003
Dear Mr. Logan:
This letter corrects our substantially equivalent letter of March 21, 2003 regarding the device name.
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 (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.
JUL 1 1 2003
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Page 2 - Mr. Logan
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Susan Runner
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
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Section 3 , rev. 1, K030331
Page 1 of 1
510 (K) Number (if known) :
Device Name : On-line Powder-free Latex Patient Examination Glove. Type II. Low Modulus, with extractable protein content labelling claim ( 50 microgram per gram of glove or less)
Indications For Use
A 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.
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Concurrence of CDRH . Office of Device Evaluation (ODE)
Prescription Use ( Per 21 CFR 801. 109 ) ()ર
Over-The-Counter Use
( Optional Format 1-2-96 )
Chin S. Lim
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Den
510(k) Number: K030331
§ 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.