(67 days)
A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
The provided text is a 510(k) premarket notification letter from the FDA to Kanam Latex Industries PVT. Limited for "Powder Free Latex Sterile Patient Examination Gloves." The document confirms substantial equivalence but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in detailed performance reports for more complex medical devices.
The device in question, "Powder Free Latex Sterile Patient Examination Gloves," is a Class I medical device. For such devices, the FDA typically assesses substantial equivalence primarily based on comparison to a legally marketed predicate device rather than requiring extensive clinical studies with specific performance metrics and acceptance criteria in the same way as, for example, an AI diagnostic tool.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or not present in this type of FDA document for this specific device.
Here's the breakdown of why the information is not present and what can be inferred:
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A table of acceptance criteria and the reported device performance: Not provided. For gloves, acceptance criteria usually relate to physical properties (tensile strength, elongation, barrier integrity, sterility), absence of powders, and biocompatibility. These are typically tested against recognized consensus standards (e.g., ASTM standards) rather than clinical performance metrics in a study report summarized in a 510(k) letter. The letter states the device is "substantially equivalent" to predicate devices, implying it meets similar performance and safety standards.
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Sample sized used for the test set and the data provenance: Not provided. Performance testing for gloves would involve laboratory testing of physical and chemical properties from a sample of gloves. The letter does not specify sample sizes or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic devices (e.g., expert consensus on images) is not relevant for examination gloves. Performance is assessed through standardized laboratory tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 AI-assisted diagnostic devices.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI or software-as-a-medical-device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance. For gloves, "ground truth" would be the objective measurements from laboratory tests (e.g., burst pressure, freedom from holes, protein content).
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The sample size for the training set: Not applicable. This device does not involve AI or machine learning that requires a training set.
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How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The FDA letter confirms that the "Powder Free Latex Sterile Patient Examination Gloves" (K052728) are substantially equivalent to legally marketed predicate devices. This determination is based on the device meeting the same indications for use and having similar technological characteristics, which would include compliance with relevant performance standards for examination gloves. The specific details of performance testing, sample sizes, and ground truth establishment (as relevant for non-AI diagnostic devices) are not included in this high-level regulatory clearance letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 5 2005
Mr. Ravi Abraham Manager Director M/S. Kanam Latex Industries PVT. Limited Ooppoottil Buildings, K.K. Road Kottayam, Kerala India 686001
Re: K052728
Trade/Device Name: Powder Free Latex Sterile Patient Examination Gloves Regulation Number: 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 24, 2005 Received: November 30, 2005
Dear Mr. Abraham:
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. Abraham
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 vours.
Sophie J. Michael Omd.
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): _ kos 2128
Device Name:POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
Indications for Use:
A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber
-Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Image /page/2/Picture/5 description: The image is a black and white drawing of an oval shape. The oval is not a perfect shape, and it has some irregularities. The oval is surrounded by a white background. The drawing is simple and does not contain any other details.
Pof Kanam Latax Indus Ltd. Ravi Abraham Mg. Director
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fukui L. Kujay, M.D. 12/15/05
(Print Name)
West Anaheim Medical Center - General Hospital
Services
§ 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.