(70 days)
The B-Care Powdered Latex Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Not Found
I am sorry, but based on the provided text, I cannot provide the detailed information requested regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for "B-Care Powdered Latex Examination Gloves."
This letter primarily:
- Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, an FDA review showed that the new device is as safe and effective as the predicate.
- Identifies the device and its indications for use: It clearly names the device and its intended purpose.
- Outlines regulatory compliance: It advises the manufacturer on ongoing regulatory requirements.
The document does not include:
- Specific acceptance criteria for device performance (e.g., tensile strength, puncture resistance, barrier integrity).
- Details of a study conducted to demonstrate that the device meets such criteria.
- Information on sample sizes for test sets, data provenance, expert qualifications, or ground truth establishment.
- Any mention of MRMC studies or standalone algorithm performance, as these gloves are a physical medical device, not an AI/software device.
To obtain the information you're looking for, you would generally need to refer to the 510(k) submission itself (which would contain the detailed test reports and methodologies) or potentially standards referenced within such a submission (e.g., ASTM standards for glove performance). The clearance letter only announces the outcome of the FDA's review.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 2005
B-Care Industries Company Limited Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K052845
K032649
Trade/Device Name: B-Care Powdered Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 2, 2005 Received: December 7, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Scellon 910(x) procession is substantially equivalent (for the devices may referenced above and have determined the active is emarketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the chelosano, to regains the of the Medical Device interstate commerce prior to reay 20, 1770, are chance with the provisions of Amendments, or to devices that have been rockeshed do not require approval of a premarket the Federal Food, Drug, and Cosmetic For (rice) and alter the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to th approval appreadon (1 Mrx). Tou niej), ral controls provisions of the Act include controls provisions of the Fet. "The gentiral others, good manufacturing practice, Icquirements for annual regainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) offect If your device Is classified (SCC above) into cantrols. Existing major regulations affecting (PMA), it may be subject to such additional controllar controllations, Title 21, Parts 800 to 898. In the Foderal your device can be found in the Code of Pederal Regains of the Federal Register.
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Page 2 - Mr. Walls
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 315sualled of a baseau.
mean that FDA has made a determination that your device complies with other requirements mean that FDA has made a decemmanen until 900 anninistered by other Federal agencies. of the Act of ally rederal statutes and regurements, including, but not limited to: registration You must comply with an the Act 3 requirements art 801); good manufacturing practice and ifsing (21 CFR Patt 8077, laboring (21 CFR Part 820); and if and 820); and if requirements as set form in the quality bjochly (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 5 10(k) This letter will anow you to begin maineting your substantial equivalence of your device to a premarket notification. The PDA milling of coses 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), If you desire specific auvice for your de at (240) 276-0115. Also, please note the regulation please contact the Other or Ochiphanes are (21CFR Part 807.97). You entitled, "Misoranuing by reference to presentation on your responsibilities under the Act from the may obtain offer general miorination on your i experience at its toll-free Division of Small or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clue
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
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Indications for Use
510(k) Number (if known): _k052845
B-Care Powdered Latex Examination Gloves Device Name:
Indications for Use: The B-Care Powdered Latex Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Image /page/2/Picture/4 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Part 21 CFR 801 Subpart D)" in a smaller font. The text is left-aligned and appears to be part of a document or label. The image is simple and contains only text.
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shala H. Murphy, MD 12/16/05
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