(79 days)
The Ya Mei First Aid Kit is intended to provide basic first aid treatment for various emergency situations, while seeking further professional medical assistance, when necessary.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Ya Mei First Aid Kit." This document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document primarily focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory requirements the manufacturer must comply with.
- Stating the intended use of the device: "The Ya Mei First Aid Kit is intended to provide basic first aid treatment for various emergency situations, while seeking further professional medical assistance, when necessary."
Therefore, I cannot provide the requested table and study details based on the given information. The prompt asks for information that is simply not present in the provided FDA letter.
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Public Health Service
APR - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ya Mei Technology Co., Ltd. % Regulatory Insight, Inc. Mr. Kevin Walls 13 Red Fox Lane Littleton, Colorado 80127
Re: K031130 Trade/Device Name: Ya Mei First Aid Kit Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's gloves Regulatory Class: II Product Code: KGO, LRR Dated (Date on original SE letter): April 8, 2003 Received (Date on original SE letter): April 23, 2003
Dear Mr. Walls:
This letter corrects our substantially equivalent letter of June 27, 2003.
We have reviewed vour 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 (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 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.
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.
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Page 2 - Mr. Kevin Walls
This letter will allow you to continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milkers
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K031130
Ya Mei First Aid Kit Device Name:
. .
Indications for Use: The Ya Mei First Aid Kit is intended to provide basic first aid treatment for various emergency situations, while seeking further professional medical assistance, when necessary.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and
Neurological Devices
510(k) Number __
Prescription Use
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).