(40 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
Powdered Latex Examination Gloves (Protein Label Claim) (150 MICROGRAMS OR LESS)
This document is a 510(k) clearance letter from the FDA for Powdered Latex Examination Gloves. It primarily addresses the device's substantial equivalence to a predicate device and outlines general regulatory compliance.
Therefore, the document does not contain any information regarding:
- Acceptance criteria and reported device performance (in a table or otherwise)
- Sample sizes (test, training)
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance studies
- Type of ground truth used or how it was established
The letter confirms the device's classification as Class I, reiterates the general controls provisions of the Medical Device Amendments, and permits the marketing of the device. The "Indications For Use" section simply defines what a patient examination glove is and its function, which is standard for such a device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three human profiles or faces merged together, with flowing lines above them that could be interpreted as hair or wings. The logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1999
Mr. Lee Aik Lim Managing Director Besglove Medicare Sdn. Bhd. Lot 6, Jalan P/2A Bangi Industrial Estate 43650 Bandar Baru Bangi Selangor Darul Ehsan, Malaysia
Re: K993495 Powdered Latex Examination Gloves Trade Name: (Protein Label Claim 150 micrograms or less) Regulatory Class: I Product Code: LYY Dated: October 11, 1999 Received: October 15, 1999
Dear Mr. Lim:
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 requlations affecting your device can be found in the Code of Federal Requlations, 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
{1}------------------------------------------------
Page 2 - Mr. Lim
the Federal Register. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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
v A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Attachment 8
| 510 (K) number (if known) : | K993495 |
|---|---|
| Device Name : | Powdered Latex Examination Gloves (Protein Label Claim) |
| (150 MICROGRAMS OR LESS) | |
| Indications For Use : |
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent 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)
SEB for Chin -----------------------------------------------------------------------------------------------------------------------------------------------------------------
(Division Sign Off) Division of Dental, Infection Control, and General Hospital Devices 510(K) Number K 99 34 95
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ ार
§ 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.