POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
Device Facts
| Record ID | K050968 |
|---|---|
| Device Name | POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES |
| Applicant | Pt. Medisafe Technologies |
| Product Code | LZA · General Hospital |
| Decision Date | Jul 12, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
The device is a disposable synthetic rubber examination glove intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner.
Device Story
Disposable synthetic rubber examination glove; worn on hands by medical personnel; acts as a barrier to prevent cross-contamination between patient and examiner; used in clinical settings; non-sterile or sterile (as indicated by product labeling).
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Material: Synthetic rubber (polychloroprene). Form factor: Disposable examination glove. Sterilization: Sterilized. Regulation: 21 CFR 880.6250, Class I, Product Code LZA.
Indications for Use
Indicated for use as a disposable synthetic rubber examination glove for medical purposes to prevent cross-contamination between patient and examiner.
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
JUL 1 2 2005
Mr. Anil Taneja Vice President PT. Medisafe Technologies JI. Batang Kuis Gg. Tambak Rejo Desa Buntu Bedimbar TJ. Morawa Medan, North Sumatra, INDONESIA 20362
Re: K050968
Trade/Device Name: Powder Free, Sterilized, Polychloroprene Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 14, 2005 Received: June 29, 2005
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major remilations 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 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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Aue Suecom 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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050968
INDICATION FOR USE Medisafe Technologies Applicant: ___________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): * ___Not known Sterilized Examination Gloves Device Name:
Indications For Use:
disposable ાંડ a The device synthetic rubber intended examination glove made of for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR Office of Device Evaluation (ODE)
Or Over-The-Counter Prescription Use Per 21 CFR 801.109 (optional Format 1-2-96)
Shula H. Murphy, M.D. 21
* For a new submission, do NOT fill in the 510(k) number blank. (Division Sign-Off)
(Division Sign-Off)
Division of Anesthesiology. General Hosi
Infection Control, Dental Devices
K050968
PT Medi Yafe Technologies JI. Batang Kuis, Gg. Tambak Rejo, Desa Buntu Bedimbar Tanjung Morawa-20362, Medan - Sumatra Utara, Indonesia Ph: 62- (061)-794
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