(26 days)
A 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.
Latex Examination Glove Powder Free, With Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein)
N/A
FDA 510(k) SUMMARY - LATEX EXAMINATION GLOVE
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JUL 12 1999
JANNA TUCKER & ASSOCIATES
198 Avenue De La D'emerald
Sparks, NV 89434-9550
Ph: 775-342-2612
Fax: 775-342-2613
510(k) SUMMARY
Submitted By:
Janna Tucker & Associates
198 Avenue de la D'emerald
Sparks, NV 89343
Phone: 775-342-2612
FAX: 775-342-2613
Contact Person:
Janna P. Tucker, Official Correspondent for
Shanghai Changzheng Latex Factory
Date of Submission: 7 June 1999
Device Name: Patient Examination Glove
Proprietary Name: (Multiple Labels) Exam Gloves, Latex, Powder-Free, with Protein Labeling.
Label/Labeling: This device will be marketed to healthcare professionals at dentist, and doctor offices, laboratories, clinics and hospitals through its intended use.
Intended Use: A 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.
Substantial Equivalence:
This device is equivalent to those in commercial distribution. They are to be worn as a protective device on the examiner's hand or finger.
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies. It is substantially equivalent to the device manufactured by Evergrade Healthcare Products SDN BHD, K973664, Latex Examination Glove, Powder-Free, with Protein Content Labeling Claim.
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Test Results (Means and/or Results): This device has met or exceeded the following standards/tests:
- ASTM D ASTM D 3758-95
- ASTM D 5151 FDA Water Leak Test (before & after aging)
- Bio-Compatibility
- Dermal Sensitization
- Primary Skin Irritation
- Bacteria
- Mold
Conclusions: This device is substantially equivalent to the device approved as K973664.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
JUL 12 1999
Shanghai Changzheng Latex Factory
c/o Janna Tucker & Associates
Ms. Janna P. Tucker
Official Correspondent
198 Avenue De La D'Emerald
Sparks, Nevada 89434-9550
Re: K992031
Trade Name: Latex Examination Glove Powder Free, With Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein)
Regulatory Class: I
Product Code: LYY
Dated: June 14, 1999
Received: June 16, 1999
Dear Ms. Tucker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Tucker
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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INDICATIONS FOR USE
APPLICANT: SHANGHAI CHANGZHENG LATEX FACTORY
510(K) NUMBER: K992031
DEVICE NAME: Latex Examination Glove, Powder-Free
WITH PROTEIN LABELING CLAIM ≤50 MCG/GM
WATER SOLUBLE PROTEIN PER GM
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_____ OR Over-The-Counter Use X
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division Sign-Off
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K992031
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.