POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
Device Facts
| Record ID | K050467 |
|---|---|
| Device Name | POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN |
| Applicant | Shen Wei (Usa), Inc. |
| Product Code | LZA · General Hospital |
| Decision Date | Mar 30, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
A patient examination gloves is a disposable device intended for medical purposes that is worn A pattent examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Device Story
Powder-free butadiene patient examination gloves with aloe coating; green color. Device functions as a physical barrier to prevent contamination between patient and examiner. Used in clinical settings by healthcare professionals. Disposable, single-use design.
Clinical Evidence
bench testing only
Technological Characteristics
Material: Butadiene; Coating: Aloe; Color: Green; Form factor: Disposable examination glove; Sterilization: Not specified.
Indications for Use
Indicated for use as a disposable medical device worn on the examiner's hands or fingers 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
MAR 3 0 2005
Ms. Cynthia Liu Service Marketing Manager Shen Wei (USA) Incorporated 2845 Whipple Road Union City, California 94587
Re: K050467
Trade/Device Name: Powder Free Butadiene Exam Gloves with Aloe, Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: February 21, 2005 Received: February 23, 2005
Dear Ms. Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your and have determined the device is substantially equivalent (for the inclications 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 Eederal Register.
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Page 2 - Ms. Liu
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 moall that I DAT mas made a statutes and regulations administered by other Federal agencies. of the Act of ally I oderal backed s requirements, including, but not limited to: registration 1 out intist contiply with and the labeling (21 CFR Part 801); good manufacturing practice aller listing (21 CF R Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ajon 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 anow Jourse FDA finding of substantial equivalence of your device to a premiarket notification. The PDF mixtis 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), If you desire specific at not 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 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/industry/support/index.html.
Sincerely yours,
Chiu 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
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## Attachment Two - R
## INDICATION FOR USE
## 510(k) Number (if known): K050467
Powder Free Butadiene Exam Gloves with Aloe, Green Color Device Name:
Indication for Use:
A patient examination gloves is a disposable device intended for medical purposes that is worn A pattent examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Prescription Use (Per 21CFR 801 Subpart D) AND/OR
Over the Counter______________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH Office of Device Evaluation (ODE)
Shula H. Murphy D 5/30/05
sion Sion-Off sion of Anesthesiology, General Hospital, tection Control, Dental De
Number: K 0504167
