NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
Device Facts
| Record ID | K042879 |
|---|---|
| Device Name | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING |
| Applicant | Sgmp Co., Ltd. |
| Product Code | LZA · General Hospital |
| Decision Date | Jan 13, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Story
Non-sterile, powder-free blue nitrile examination glove; features vanilla scenting. Worn on hands by healthcare personnel to provide a protective barrier; prevents contamination between clinician and patient. Device meets ASTM-D6319-00aE1 standards for nitrile examination gloves.
Clinical Evidence
Bench testing only; device meets ASTM-D6319-00aE1 standard specifications for nitrile examination gloves.
Technological Characteristics
Material: Nitrile; powder-free. Standards: ASTM-D6319-00aE1. Form factor: Examination glove. Scenting: Vanilla. Regulatory Class: I. Product Code: LZA.
Indications for Use
Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient.
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.
Predicate Devices
- POWDER FREE NITRILE EXAM GLOVES (K000868)
Submission Summary (Full Text)
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K042879
# JAN 1 3 2005
#### APPENDIX L
#### 510(k) SUMMARY
### SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER-FREE BLUE NITRILE EXAMINATION WITH VANILLA SCENTING
Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kampaengpetch, Rattaphum, Songkhla 90180, Thailand.
- Tucker & Associates Submitted By: Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emerald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: Tuckerjan@aol.com
Equivalent Predicate Device: POWDER FREE NITRILE EXAM GLOVES which was granted a 510 (k) # K000868 as shown in APPENDIX M
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
#### Device Information:
Trade Name - NON-STERILE POWDER FREE BLUE NITRILE EXAMINATION GLOVES WITH VANILLA SCENTING
Common Name - Exam gloves
Classification Name - Patient examination glove (per 21 CFR 880.6250)
ﮯ
Classification Information - Class I nitrile patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D6319-00aEl Standard Specification for Nitrile Examination Gloves for Medical Application.
#### Device Description:
Class I nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of ASTM-D6319-00aE1 Standard Specification for Nitrile Examination Gloves for Medical Application.
#### Intended Use of Device:
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2005
SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K042879
Trade/Device Name: Non-Sterile, Powder-Free Blue Nitrile Examination J Gloves with Vanilla Scenting Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 31, 2004 Received: January 4, 2005
Dear Ms. Tucker:
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.
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Page 2 -- Ms. Tucker
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 (301) 594-0115. 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/dsma/dsmamain.html
Sincerely yours,
Cures
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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# Indications for Use
510(k) Number (if known): K042879
## Device Name: _NON-STERILE, POWDER-FREE BLUE NITRILE EXAMINATION GLOVES WITH VANILLA SCENTING
Indications For Use: This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Prescription Use (Part 21 CFR 801 Subpart D)
:
AND/OR
Over-The-Counter Use __X _____________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Smythe Michael Oard
Owision Sign-Off) Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
K042879 510(k) Number:________________________________________________________________________________________________________________________________________________________________
