YA MEI FIRST AID KIT

K031130 · Ya Mei Technology Co., Ltd. · KGO · Jun 27, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031130
• Device Name: YA MEI FIRST AID KIT
• Applicant: Ya Mei Technology Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1
• Attributes: Therapeutic

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.

Device Story

Ya Mei First Aid Kit provides basic first aid supplies for emergency situations. Used by general public or caregivers to provide temporary treatment while awaiting professional medical care. Device contains various medical supplies for wound care or minor injury management. No complex processing, software, or electronic components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

First aid kit containing various medical supplies. No electronic components, software, or complex materials described.

Indications for Use

Indicated for individuals requiring basic first aid treatment for emergency situations while awaiting professional medical assistance.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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