(48 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50 MICROGRAMS OR LESS
The provided text is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim of 50 micrograms or less)." This type of document does not typically contain acceptance criteria or study details in the way a clinical study report or a technical design document for a complex medical device (like an AI algorithm) would.
A 510(k) clearance is based on demonstrating "substantial equivalence" to a predicate device already on the market. This often involves showing that the new device meets recognized standards, performs similarly in basic tests, and has the same intended use and technological characteristics as the predicate. The focus is usually on manufacturing, material conformity, and basic performance parameters relevant to the device's function (e.g., barrier integrity for gloves), rather than complex diagnostic accuracy studies.
Therefore, many of the requested categories for acceptance criteria and study information will not be directly available or applicable from this specific document.
However, I can extract what is implied or stated (even if it's minimal) and indicate where information is missing or not relevant for this type of device and document.
Implied Acceptance Criteria and Performance (Based on Device Type and Clearance Letter):
The core "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing legally marketed devices.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implied) | Reported Device Performance (Implied from Clearance) |
|---|---|
| Material: Powderfree Latex | Met (Device name specifies "Powderfree Latex") |
| Coating: Polymer Coated | Met (Device name specifies "Polymer Coated") |
| Protein Level: ≤ 50 micrograms/gram of glove | Met (Device name specifies "Protein Label Claim of 50 micrograms or less") |
| Intended Use: Patient Examination Glove (disposable, prevents contamination) | Met (Indicated Use matches predicate devices) |
| Performance: Substantially equivalent to predicate | Deemed substantially equivalent by FDA |
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Sample size used for the test set and the data provenance:
- Not specified in this document. For gloves, testing would typically involve batches of manufactured gloves to assess properties like tensile strength, elongation, barrier integrity (e.g., freedom from pinholes), and protein levels. This would likely be internal testing by the manufacturer.
- Provenance: This would be generated by the manufacturer, likely from their production batches. Country of origin for testing is not stated, but the manufacturer is based in Malaysia.
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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/specified for this type of device. "Ground truth" in the context of examination gloves isn't established by expert consensus on diagnoses. It's established by laboratory testing against recognized standards (e.g., ASTM standards for medical gloves) for physical properties and chemical composition. The "experts" would be laboratory technicians or engineers qualified to perform such tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for objective laboratory testing of glove properties.
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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 is a medical glove, not an AI-powered diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical glove, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device would be established by objective laboratory measurements of physical properties (e.g., barrier integrity, tensile strength, elongation) and chemical analysis (e.g., protein content) in accordance with relevant national or international standards (e.g., FDA guidance documents, ASTM standards).
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The sample size for the training set:
- Not applicable. This is not a machine learning/AI device. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary, the provided document is an FDA clearance letter for a low-risk medical device (examination gloves), which is fundamentally different from devices that would require complex clinical trials, AI algorithm validation, or expert consensus "ground truth" studies. The "study" for this device would involve internal validation testing by the manufacturer to ensure the gloves meet specifications and recognized standards, which FDA reviews for substantial equivalence to a predicate device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms, with three curved lines forming the body and arms. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1999
Mr. Lee Aik Lim Managing Director Besglove Medicare Sdn. Bhd. Lot 6, Jalan P/2A Bangi Industrial Estate 43650 Bandar Baru Banqi Selangor Darul Ehsan, Malaysia
Re : K993500 Trade Name: Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim of 50 micrograms or less) Regulatory Class: I Product Code: LYY October 11, 1999 Dated: Received: October 15, 1999
Dear Mr. Lim:
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 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). T You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will Failure to comply with the GMP verify such assumptions. regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Lim
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 regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patino Cuerdi //oc
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Attachment 9
K 99 35 ∅∅
510 (K) number (if known) : _
Device Name : Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50 MICROGRAMS OR LESS
Indications For Use :
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clim S. Lim
(Division Sign Off) Division of Dental, Infection Control, and General Hospital Dev 510(K) Number
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use ાર
§ 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.