(95 days)
A patient examination glove is disposable device intended for mediod purposes that is donned by the user on the hands prevent possible contamination between patient and examiner.
Colored and Flavored Pre-powdered Latex Pattent Examination Gloves , P.ok - Tulli-Feath, Brice - River , Gram - pipero - pipermint , Lives , P. Contains is megro on Tess af Tual City & Charler experiment , States , policings
This document is a 510(k) clearance letter from the FDA for a medical device: Natural Rubber Pre-Powdered Colored and Flavored Patient Examination Gloves.
Based on the provided text, there is no acceptance criteria or study information that proves the device meets specific performance criteria.
Here's why:
- 510(k) Clearance: This is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process primarily relies on demonstrating equivalence to an existing device, not necessarily on new studies proving specific performance metrics beyond what was established for the predicate.
- "Contains Claim of 150 mcgm or Less of Total Water Extractable Protein Per Gram": This is a claim about the device's composition, specifically regarding its protein content to potentially reduce allergic reactions. While it implies a target, the document does not present any study data demonstrating that this claim was met for the specific device under review. It's a characteristic of the product, not necessarily a performance acceptance criterion in the context of a clinical study or effectiveness study described here.
- Focus of the Letter: The letter's content is entirely administrative, confirming that the device is "substantially equivalent" to predicate devices and can therefore be marketed. It discusses regulatory classes, general controls, and compliance with manufacturing practices. It does not delve into detailed performance studies or their results.
Therefore, I cannot fill out the requested table regarding acceptance criteria and study data using the provided scanned document. The document describes a regulatory clearance based on substantial equivalence, not a detailed performance study.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1999
Mr. Anil Taneja General Manger Pt. Irama Dinamika Latex Jl. Kapten Pattimura No. 23/235 Medan 20153 INDONESIA
Re : K984449 Natural Rubber Pre-Powdered Colored and Trade Name: Flavored Patient Examination Gloves (Pink with Tutti-Fruti Flavor, Blue with Lemon Flavor, and Green with Peppermint Flavor) Contains Claim of 150 mcgm or Less of Total Water Extractable Protein Per Gram Requlatory Class: I Product Code: LYY December 12, 1998 Dated: Received: January 19, 1999
Dear Mr. Taneja:
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. ਜ 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. 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.
{1}------------------------------------------------
Page 2 - Mr. Taneja
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 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
Timothy A. 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/4 description: The image shows three black shapes against a white background. The shape on the left is a rectangle with a square on top. The shape in the middle is a tall rectangle, and the shape on the right is a tall rectangle.
IRAMA DINAMIKA LATEX PT. Jl. Kapten Pattimura No. 23 / 235, Medan - 20153, Indonesia PHONE : (62-061) 515-834; 576-502; FAX: 553-389 E- mail : ptirama@idola.net.id
Attachment 1
Indication for Use Statement.
INDICATION FOR USE Applicant: PT Irama Dinamika Latex 510(k) Number (if known): 984449 - pending Device Name: Colored and Flavored Pre-powdered Latex Pattent Examination Gloves , P.ok - Tulli-Feath, Brice - River , Gram - pipero - pipermint , Lives , P.
Contains is megro on Tess af Tual City & Charler experiment , States , policings
Indications For Une: A patient examination glove is disposable device intended for mediod purposes that is donned by the user on the hands prevent possible contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ancurrence of CDHR Office of Device Evaluation (ODE)
Prescription Use Or Over-The-Court Per 21 CFR 801.109 (optional Formax 1-2-96)
Baird for Chir
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 19844444
§ 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.