(79 days)
A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications that would allow for a response to the user's request. The document primarily focuses on regulatory approval and classification.
{0}------------------------------------------------
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 stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph H. Neuser President Derma Care Plus Products, LLC 1500 River Pines Drive Green Bay, Wisconsin 54311
JUN - 7 2007
Re: K070760
Trade/Device Name: Power Free Chlorinated Latex Patient Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with a Protein Claim of 50 Microgram or Less per Gram of Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 25, 2007 Received: May 30, 2007
Dear Mr. Neuser:
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.
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
{1}------------------------------------------------
Page 2 - Mr. Neuser
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 vour 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/industry/support/index.html.
Sincerely vours,
Chin Lin, Ph.D.
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
{2}------------------------------------------------
Indications for Use Statement: Include the following or equivalent Indications 3.0 for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE STATEMENT
Applicant: DERMA CARE PLUS PRODUCTS, LLC
510(k) Number (if known): N/A
Device Name: POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE
Indications For Use: A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.
Prescription Use: NO
and /or Over-The-Counter Use: YES
(21 CFR 801 Subpart C)
Shule A. Murphy, MD
sion of Anesthesiology, General Hospital, Control, Control, Dental Devicess
(K) Number: K070760
3.0
§ 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.