(75 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.
Powdered Nitrile Examination Gloves
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves." This document is a regulatory communication, not a scientific study report describing device performance or acceptance criteria in the typical sense of a clinical or performance study of an AI/software device.
Therefore, the specific information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) cannot be extracted from the provided text.
The document states that the device is "substantially equivalent" to predicate devices, meaning it has sufficiently similar characteristics and indications for use as a device already legally marketed. For examination gloves, the "performance" typically refers to physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from holes), which are usually tested against established international standards (like ASTM or ISO standards for medical gloves). The 510(k) process involves demonstrating compliance with these standards, but the detailed results of those tests are not typically included in the final clearance letter itself.
The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or human-AI improvement.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is concerned with the regulatory clearance of a physical medical device (examination gloves), not a software or AI-driven diagnostic or therapeutic device that would undergo the types of studies described in your prompt.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG / 1 1998
Mr. Lee Aik Lim Managing Director Besglove Medicare Sdn. Bhd. Lot 6, Jalan P/2A, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor Darul Ehsan, MALAYSIA
Re : K981879 Powdered Nitrile Examination Gloves Trade Name: Requlatory Class: I Product Code: LZA Dated: May 7, 1998 Received: May 28, 1998
Dear Mr. Lee Aik 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in 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
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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 regulation (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,
S. Dutman
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 7
981879
510(k) number(if known):
Device Name: Powdered Nitrile Examination 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 contamination between patient and prevent finger to examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Q. S. Ps.
(Division Sign Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.