(67 days)
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Powder-free Latex Examination Gloves with Protein Labeling Claim (50 micrograms OR LESS)
This document is a 510(k) premarket notification for Glovco Powder-Free Latex Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a letter from the FDA acknowledging the 510(k) submission and determining substantial equivalence, along with the device's indications for use.
Therefore, I cannot provide the requested information about acceptance criteria and a study from the supplied text.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1999
Tan Penq Hock Managing Director Glovco (M) Sdn. Bhd. Lot 760 (Block A), Jalan Haji Sirat Off Jalan Meru 42100 Klanq Selangor Darul Ehsan MALAYSIA
Re : K991554 Trade Name: Glovco, Powder-Free Latex Examination Gloves, With Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: April 29, 1999 Received: May 3, 1999
Dear Tan Peng Hock:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਰੋ 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
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this response to your premarket notification Please note: submission does not affect any obligation you might have under babmisblom actbrough 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 findinq 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 oriec of Comprising, wisbranding by reference to ene arket 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.fdq.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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PREMARKET NOTIFICATION [510(K)] FOR POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
: GLOVCO (M) SDN BHD. Applicant Date : April 29, 1999.
Page 5 of 11
3.0 INDICATION FOR USE
510(K) Number (if known) : K991554
: Powder-free Latex Examination Gloves with Protein Labeling Claim Device Name 50 micrograms OR LESS) Indications For Uše:
"A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient".
(PLEASE DO NOT WRIE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Qhin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510/k) Number _
§ 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.