SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
Device Facts
| Record ID | K011717 |
|---|---|
| Device Name | SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES |
| Applicant | Sunmax Enterprise Shanghai Co. , Ltd. |
| Product Code | LZA · General Hospital |
| Decision Date | Aug 14, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
A powdered patient examination glove is a disposable device made of natural rubber latex or synthetic polymer intended to be worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Device Story
Sunmax Blue Nitrile Powdered Examination Glove; disposable device; worn on hands by healthcare personnel; prevents cross-contamination between patient and examiner; intended for patient examination settings.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Nitrile material; powdered; disposable; examination glove form factor.
Indications for Use
Indicated for use as a disposable patient examination glove to prevent 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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## AUG 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sunmax Enterprise Shanghi Company Limited C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
K011717 Re: Sunmax Blue Nitrile Powdered Trade/Device Name: Examination Gloves 880.6250 Requlation Number: Requlatory Class: I Product Code: LZA Dated: May 31, 2001 Received: June 4, 2001
Dear Ms. Falk:
We have reviewed your Section 510(k) notification of intent to we have reviewed referenced above and we have determined the market is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the chorobromate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che chat have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions or che roused 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 (Premarket Approval), it may be subject to such additional controls. Existing major be bubless affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodic go mill verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
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Page 2 - Falk
In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ent affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic chrough 542 or the noorol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 markees produces overmits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4622. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). _ Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Obtained from the Divisumer 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 yours,
Patricia Cunniffe for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## SUNMAX ENTERRPISE SHANGHAI CO.,LTD
Image /page/2/Picture/1 description: The image shows a logo with a stylized handprint above the word "Modac". The handprint is black and appears to be on top of a circle. To the right of the word "Modac" is a small circle with three dots inside.
The Vangard of Vinyl Gloves
No.2 New industrial Area. Zhu Hang Zhen. Jin Shan County, Shanghal, China. TEL: (886) 2 2713 6677 FAX: (886) 2 2546 2480
April 12th. 2001
INDICATIONS FOR USE STATEMENT
of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name Sunmax Blue Nitrile Powdered Glove
Indications For Use:A powdered patient examination glove is a disposable device made Thorical for USE A polloer of partier of pat roman provent contamination between patient and examiner.
Tex Lee
Alex Lee President SUNMAX ENTERPRISE SHANGHAI CO., LTD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|----------------------|--------------------------------------------------------|
| Prescription Use | Over-The-Counter Use X |
| (Per 21 CFR 801.109) | OR (Optional Format) |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number V 011717
