(55 days)
A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.
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This document is a 510(k) clearance letter from the FDA for "Hypoallergenic Latex Patient Exam Gloves." It explicitly states that the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This type of clearance does not involve the detailed performance studies or statistical analyses typically required for novel medical devices. The FDA determines substantial equivalence primarily based on comparing the new device's technological characteristics and intended use to a legally marketed predicate device.
Therefore, the requested information regarding acceptance criteria, specific performance studies, sample sizes, expert involvement, and ground truth establishment is not available in this document and is not typically part of a 510(k) notification for devices like examination gloves.
Here's why and what can be inferred:
- Acceptance Criteria & Device Performance: For examination gloves, acceptance criteria relate more to material properties, physical dimensions, leak resistance, tensile strength, and biocompatibility, as defined by recognized standards (e.g., ASTM standards for medical gloves) that ensure they meet their intended protective function. The document confirms the device is a "patient examination glove" and is "hypoallergenic," implying it meets general performance standards for such devices and has been shown not to cause common allergic reactions associated with latex. However, specific numerical acceptance criteria and reported device performance (e.g., specific AQL levels for pinholes) are not detailed in this clearance letter.
- Study That Proves the Device Meets Acceptance Criteria: The "study" for a 510(k) of this nature typically involves demonstrating that the new device meets relevant consensus standards (like ASTM D3577 for rubber examination gloves) and that its hypoallergenic properties are substantiated, often through specific testing (e.g., protein content testing) compared to predicate devices. This isn't a clinical trial in the sense of comparing diagnostic accuracy or clinical outcomes.
- Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These concepts are relevant to software or AI-driven medical devices, or complex diagnostic/therapeutic devices that require extensive clinical validation. For a Class I device like an examination glove, these are generally not applicable. The equivalence is established by comparing technical specifications and performance against recognized standards or an existing predicate device.
- Data Provenance: Not applicable in the context of this device's clearance.
- Type of Ground Truth Used: For gloves, "ground truth" would be objective measurements against material specifications and safety standards (e.g., laboratory tests for protein content, leak resistance, physical dimensions).
- How Ground Truth for Training Set Was Established: Not applicable as a training set for machine learning is not used here.
In summary, this document is a regulatory clearance based on substantial equivalence, not a detailed performance study report. The questions posed are highly relevant for artificial intelligence/machine learning devices or those requiring extensive clinical studies, but not for a Class I device like examination gloves cleared via the 510(k) pathway.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 28 1998
Mr. Anil Taneja General Manager Pt. Irama Dinamika Latex Jl. Kapten Pattimura No. 23 / 235 Medan 20153 INDONESIA
Re : K980848 Hypoallergenic Latex Patient Exam Gloves-Trade Name: Pre-Powdered, Green Requlatory Class: I Product Code: LYY Dated: February 25, 1998 Received: March 4, 1998
Dear Mr. Taneja:
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 qeneral 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 requlations 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 Other qeneral 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,
Timothy A. Ulatowski
Tir 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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for
K980848 5 10(k) Number (if known): Pour deres Device Name: HYPOALLERGENICALATEX EXAMINATION GLOVES GREEN Indications For Use: A patient examination glove is a disposable device intended is donned by doctors and healthcare workers medical purposes that possible infection/contamination when as protection against
examining a patient.
(PLEASE IDO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
OR
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Optional Format 1-2-96)
Over-The-Counter Use
§ 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.