(98 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.
Master Guard Disposable Nitrile Powdered Blue Examination Gloves
This FDA 510(k) clearance letter for "Master Guard Disposable Nitrile Powdered Blue Examination Gloves" does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the way requested.
The letter primarily focuses on the regulatory determination of substantial equivalence to a predicate device, which means the device is considered as safe and effective as a legally marketed device that was on the market prior to May 28, 1976.
Specifically, the document does not provide any information for the following requested items:
- A table of acceptance criteria and the reported device performance: This type of data is typically found in a summary of safety and effectiveness or a test report, not in the clearance letter itself.
- Sample size used for the test set and the data provenance: There is no mention of specific test sets or their size/origin.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no such test is described.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable (this is a physical glove, not an AI algorithm).
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable (this is a physical glove, not an AI algorithm).
- How the ground truth for the training set was established: Not applicable.
The document does state the 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."
To find information on acceptance criteria and performance data for this type of device, one would typically need to refer to:
- Voluntary consensus standards: Such as ASTM standards for medical examination gloves (e.g., ASTM D6319 for nitrile examination gloves), which define performance requirements for properties like tensile strength, elongation, puncture resistance, and barrier integrity (e.g., AQL for pinholes).
- The 510(k) submission itself: The actual submission would contain the test reports and data that demonstrate the device meets these standards and any other specific performance claims, enabling the FDA to determine substantial equivalence.
Without access to the actual 510(k) submission, the requested information cannot be extracted from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2007
Mr. Hue Kon Fah Deputy General Manager High Momentum Sdn Bhd No 12, Lorong Batu Nilam 6A. Bandar Bukit Tinggi Klang, Pelabuhan Klang Selangor Daurl Ehsan, MALAYSIA 42100
Re: K071207
Trade/Device Name: Master Guard Disposable Nitrile Powdered Blue Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 14, 2007 Received: July 23, 2007
Dear Mr. Kon Fah:
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. Kon Fah
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.
Signature
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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Indications for Use
510(k) Number (if known): K071207
Device Name: Master Guard Disposable Nitrile Powdered 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 X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shisha A Murphy NP
esiology. General H
510(k) Number: K071202
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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.