(90 days)
A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Nitrile Blue Examination Gloves
The provided text is a 510(k) premarket notification letter from the FDA for Powdered Nitrile Blue Examination Gloves. This document is for a medical device that falls under Class I (general controls) and is determined to be substantially equivalent to existing predicate devices.
Crucially, this type of FDA document for a Class I general control device like examination gloves does NOT contain the kind of detailed clinical study information requested in your prompt.
The questions you've asked (about acceptance criteria, specific study designs like MRMC, sample sizes, ground truth establishment, expert qualifications, etc.) are typically associated with higher-risk medical devices (Class II with Special Controls or Class III PMA devices) that require more robust clinical evidence to demonstrate safety and effectiveness.
For Class I devices like examination gloves, "acceptance criteria" primarily relate to performance standards (e.g., tear resistance, barrier integrity, biocompatibility, dimensions) which are usually met through bench testing and adherence to recognized consensus standards (like ASTM standards for medical gloves) during manufacturing. The "study" proving these criteria are met would be these bench tests, not clinical trials in the way you're describing.
Therefore, I cannot provide answers to your specific questions based on the provided document. The document confirms the device's classification, its intended use, and its substantial equivalence to a predicate, but does not detail a clinical study with elements like expert adjudication or MRMC analysis.
However, if we were to infer what "acceptance criteria" and "study" would look like for such a device, it would generally involve:
- Acceptance Criteria (hypothetical, based on common glove standards):
- Barrier Integrity (e.g., AQL for pinholes): A certain Acceptable Quality Level (AQL) for pinholes (e.g., 2.5% for general purpose, 1.5% for surgical)
- Tensile Strength & Elongation: Meeting minimum breaking strength and elongation percentages before break.
- Dimensions: Conforming to specified length, palm width, and finger thickness.
- Powder Residue (if powdered): Below a specified limit (though this device is "Powdered Nitrile Blue" meaning it likely contains powder, but standards might set a max acceptable level or require specific labeling).
- Biocompatibility: Non-irritating, non-sensitizing (tested via ISO 10993 standards).
- Freedom from hazardous substances: Compliance with relevant regulations for restricted substances.
- "Study" to prove criteria conformance (hypothetical):
- Bench Testing: Lot-by-lot or sampling-based testing for AQL (water leak test for pinholes), tensile properties, dimensions, and powder content.
- Biocompatibility Testing: In vitro or in vivo tests (e.g., cytotoxicity, irritation, sensitization assays) to ISO 10993 standards.
None of these details, however, are present in the provided FDA letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2006
Dr. Lim, Wee-Chai Managing Director Great Glove Sdn Bhd Lot, 5091, Jalan Teratai, Batu 5, Off Jalan Meru, 41050 Klang, Selangor, Darul Ehsan MALAYSIA
Re: K052955
Trade/Device Name: Powdered Nitrile Blue Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 5, 2006 Received: January 10, 2006
Dear Dr. Chai:
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 cither 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 - Dr. Chai
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 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,
Syttee y Michael Om's.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052955
Device Name: Powdered Nitrile Blue Examination Gloves
Indications For Use:
A patient examination Nitrile Blue Powdered 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 BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Murphy, MD 1/19/06
…ology, General Hospital,
…on Control, Dental Devices
K05295
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§ 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.