(32 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
Gentle Skin and (multiple labels) Powder Free, Polyment Coated Glove (With Protein Label Claim)/ 50 ml
This document is a 510(k) clearance letter from the FDA for a medical device: "Gentle Skin and (Multiple Labels) Powder Free, Polymer Coated Glove (With Protein Label Claim) (50 Micrograms or Less)". It declares substantial equivalence to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study proving device performance in the way typically expected for an AI/CAD device. This document is a regulatory clearance for a medical glove, not for a software or AI-based diagnostic tool.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study given the input. The questions in the prompt (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set size) are relevant for AI/CAD devices but not for a physical product like a medical glove, especially based on the information provided in this 510(k) summary.
The only "performance" claim mentioned is "50 Micrograms or Less" related to protein content. This implies a chemical or material property, not diagnostic accuracy.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing its wings or feathers.
MAR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ho Weng Fatt Managing Director Rosner Mautby Meditrade (Thailand) Limited 199 Moo11 Tambon Banpru Hatyai, Songkhla 90250 THAILAND
Re: K040448
Trade/Device Name: Gentle Skin and (Multiple Labels) Powder Free, Polymer Coated Glove (With Protein Label Claim) (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Parent Examination Glove Regulatory Class: I Product Code: LLY Dated: February 20, 2004 Received: February 20, 2004
Dear Mr. Fatt:
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 markcted in interstate commerce prior to May 28, 1976, the cnactment 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 (sec 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 - Ms. Rivkowich
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 (301) 594-5618. 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/dsma/dsmamain.html
Sincerely yours.
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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Attachment II
Rosner-Mauthy Meditrade (Thailand) Ltd. 510(K) Premarker Natification Patient Examination Cloves, Latex, Powder Free, Polymer Coated With Protein Claim
INDICATION FOR USE
Rosner Mautby Meditrade (Thailand ) Ltd. Applicant : 199 Moo 11 Tambon Banpru Hatyai, Songkhla 90250 Thailand
510 (k) Number : K 040448
: Gentle Skin and (multiple labels) Powder Free, Polyment Device Name Coated Glove (With Protein Label Claim)/ 50 ml
Indication For Use :
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Martha T. O'Lone
(Div/sion Sign-Division of Anesthesiology, General Ho Infection Control, Dental
510(k) Number: K040448
§ 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.