MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
Device Facts
| Record ID | K040607 |
|---|---|
| Device Name | MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES |
| Applicant | Pt. Medisafe Technologies |
| Product Code | LZA · General Hospital |
| Decision Date | Apr 22, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
A patient examination glove made of synthetic rubber is a disposable medical device intended for medical purposes worn on the examoiners hands or fingers to prevent possible contamination between patient and examiner.(Tested for Chemo Use
Device Story
Disposable synthetic rubber patient examination glove; worn on hands/fingers by healthcare personnel during examinations. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Tested for resistance to chemotherapy agents. Used in clinical settings; no specialized operation required. Provides protection to both patient and clinician by reducing exposure to biological contaminants.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Material: Synthetic rubber (chloroprene). Form factor: Disposable examination glove. Tested for chemotherapy drug permeation. Class I medical device. Product code: LZA.
Indications for Use
Indicated for use as a disposable patient examination glove worn by examiners to prevent cross-contamination between patient and examiner. Tested for use with chemotherapy agents.
Regulatory Classification
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.
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## APR 2 2 2004
Ms. Anil Taneja Vice President PT. MediSafe Technologies J1. Let. Jend. S. Parman No. 23 Medan 20153 INDONESIA
Re: K040607
Trade/Device Name: Modification to Powder-free Colored and Flavored Chloroprene Patient Examination Gloves, Tested for Chemo Use Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 10, 2004 Received: April 13, 2004
Dear Mr. Taneja:
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 cither 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. Taneja
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advised mat I Da determination that your device complies with other requirements mean that I DT mas made statutes and regulations administered by other Federal agencies. or the receiver any I ouchar the Act's requirements, including, but not limited to: registration 1 ou inust comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice and and listing (21 CF Part 801), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quardiation 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) I mis letter will anon you to objacting of substantial equivalence of your device to a premarket nottreation - I - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not to roo pliance at (301) 594-4618. 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 may obtain 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 vours,
Kein Muly
for 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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Image /page/2/Picture/0 description: The image shows the logo for MediSafe Technologies. The logo consists of a stylized letter "M" formed by three thick, black, angled lines. Below the symbol, the word "MediSafe" is printed in a bold, sans-serif font, with the word "TECHNOLOGIES" appearing in a smaller, lighter font underneath.
## PT. MediSafe TECHNOLOGIES
INDICATION FOR USE
: Medisafe Technologies Applicant 510(k) Number (if known) : Not Known : Examination Gloves Device Name Indications For Use : A patient examination glove made of synthetic rubber is a disposable medical device intended for medical purposes worn on the examoiners hands or fingers to prevent possible contamination between patient and examiner.(Tested for Chemo Use
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
940
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Martha T. O'Lone
(Division Sign-C (Division Sign-Off)
Division of Anesthesiology, General Hospital. Infection Control, Dental Device
510(k) Number
