(291 days)
A patient examination Powder Free Nitrile Blue Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
POWDER FREE NITRILE BLUE EXAMINATION GLOVE
This document is a 510(k) clearance letter for a "Powder Free Nitrile Blue Examination Glove." It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced medical devices with complex algorithms.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. Substantial equivalence for examination gloves is primarily based on meeting recognized consensus standards for physical properties and barrier integrity.
Therefore, many of the requested details about acceptance criteria and study methodology are not applicable to this type of device and document.
However, based on the nature of examination gloves, we can infer some general acceptance criteria and the type of testing usually performed to demonstrate substantial equivalence, even if the specific study details are not in this letter.
Here's an attempt to answer your questions by inferring common requirements for examination gloves where the document doesn't explicitly state them:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance in the manner of a clinical study or performance report for an AI/algorithm-based device. For examination gloves, acceptance criteria are typically defined by recognized consensus standards (e.g., ASTM D6319 for Nitrile Examination Gloves). These standards cover properties such as:
| Acceptance Criteria (Inferred from ASTM D6319 for Nitrile Gloves) | Reported Device Performance (Not explicitly in this document, but implied by 510(k) clearance) |
|---|---|
| Physical Properties (before aging): | (Implied to meet or exceed standard requirements) |
| Tensile Strength (MPa) | (e.g., >14 MPa, typical) |
| Elongation at Break (%) | (e.g., >500%, typical) |
| Physical Properties (after accelerated aging): | (Implied to meet or exceed standard requirements) |
| Tensile Strength (MPa) | (e.g., >14 MPa, typical, with specific % retention) |
| Elongation at Break (%) | (e.g., >400%, typical, with specific % retention) |
| Barrier Integrity (Water Leak Test): | (Implied to meet standard Acceptable Quality Limit (AQL)) |
| Acceptable Quality Limit (AQL) for pinholes | (e.g., AQL 2.5%, maximum 2.5% failure rate for water leak test per lot) |
| Biocompatibility: | (Implied to be biocompatible, typically tested per ISO 10993) |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation | Non-irritating |
| Other (e.g., Dimensions, Powder Residue): | (Implied to meet standard requirements) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) letter. Testing for examination gloves to a consensus standard generally involves a sampling plan from production lots. The specific sample sizes would be defined by the relevant ASTM or ISO standards (e.g., for AQL testing). The device is manufactured by Liwe Trading in Malaysia, suggesting the testing data would originate from Malaysia or a contract lab. The testing is typically prospective for each new lot/design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to examination gloves. "Ground truth" in the context of expert consensus is relevant for diagnostic devices that interpret signals or images. For gloves, performance is measured against objective physical and chemical properties using standardized test methods, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for examination gloves. Performance is measured objectively through lab tests, not by human adjudication of complex findings.
5. 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 for an examination glove, not an AI/algorithm-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is for an examination glove.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For examination gloves, the "ground truth" for performance is defined by adherence to objective physical, chemical, and barrier integrity criteria established in recognized consensus standards (e.g., ASTM, ISO). These are determined through laboratory testing (e.g., tensile strength testing, water leak tests, biocompatibility assays), not expert consensus in the diagnostic sense.
8. The sample size for the training set
Not applicable. Examination gloves are not AI/machine learning devices that require training sets. Their performance is inherent in their design and manufacturing process, validated through physical testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. K. M. Lee Executive Director Liwe Trading 49, Jalan SS 2/19 47300 Petaling Jaya Selangor Darul Ehsan Malaysia 47300
MAR 1 9 2007
Re: K061504
Trade/Device Name: Powder Free Nitrile Blue Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 26, 2007 Received: March 2, 2007
Dear Mr. Lee:
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 either 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 - Mr. Lee
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.
Chiu-Ling, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
510 (k) Number (if known) : KOG 1504
POWDER FREE NITRILE BLUE EXAMINATION GLOVE Device Name :
Indication For Use :
A patient examination Powder Free Nitrile Blue 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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila A. Murphy, M.D.
Concurred
Anasthaziology, General Hospical con Control, Dental Devices
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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.