(59 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Polymer Coat, Powder Free, Latex Examination Gloves
This is a premarket notification (510(k)) letter from the FDA to Smart Glove Corporation Sdn. Bhd. for their "Polymer Coat, Powder Free, Latex Examination Gloves". The letter grants market clearance based on substantial equivalence to a predicate device.
Unfortunately, the provided text does not contain the acceptance criteria or a study that directly proves the device meets those criteria.
What the document does provide is:
- Device Name: Polymer Coat, Powder Free, Latex Examination Gloves
- Intended Use: "This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
- Regulatory Class: I
- Product Code: LYY
- 510(k) Number: K991624
To answer your specific questions related to acceptance criteria and a study, this document is insufficient. A 510(k) submission typically includes testing data to demonstrate substantial equivalence, but that data is not part of this public clearance letter. You would need to access the full 510(k) submission (which is generally not publicly available in detail) to find the specific performance data and acceptance criteria.
Therefore, I cannot provide the requested table or detailed study information based on the text provided.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1999
Mr. Foo Khon Pu Managing Director Smart Glove Corporation Sdn. Bhd. Lot 6487, Batu 5% Sementa, Jalan Kapar 42100 Klang Selangor Darul Ehsan MALAYSIA
Re : K991624 Polymer Coat, Powder Free, Latex Examination Trade Name: Gloves Requlatory Class: I Product Code: LYY May 8, 1999 Dated: Received: May 11, 1999
Dear Mr. Foo Khon Pu:
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. 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Mr. Foo Khon Pu
this response to your premarket notification Please note: Please noce: this rebported on pobligation you might have under submission accommon and of for devices under the Sections 331 through 318 chool provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as This lecter will and (k) premarket notification. The FDA described in your 510 m, promatence of your device to a legally Finding of substancial equirality in a classification for your marketed predicate device robals, as a proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regulacion (21 crit rares), please contact the Office of Villo draghosere actross, , p. Additionally, for questions on Compilance at (301) 337 issues of your device, please contact che Dromocion and advorozed (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference bo the regulacion cherosou, 21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsibilitiis and Manufacturers Assistance obtained from the Brvibron or 6301) or (301) 443-6597 or at at its coll free namber (o://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
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the words "SMART GLOVE CORPORATION SDN. BHD." in bold, black letters. The words are arranged in three lines, with "SMART GLOVE" on the first line, "CORPORATION SDN." on the second line, and "BHD." on the third line. The text appears to be a company name or logo.
Company No. 403570 - D
Page 3 of 50
3.0 Indication for Use Statement.
INDICATION FOR USE
SMART GLOVE CORPORATION SDN BHD. Applicant :
510(k) Number K99 | 624
Polymer Coat, Powder Free, Latex Examination Gloves Device Name:
Indication For Use :
This glove is disposable and intended for medical purpose that is worn on the examiner's hand 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 Per 21 CFR 801.109 OR
Over-The-Counter (Optional Format 1-2-96)
Clim S. Lin
(Division Sign-Off Division of Dental. Inf and General Hospit 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.