(114 days)
A patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Powdered Latex Examination Gloves Contains 200 microgram or less of total water Extractable Protein per gram
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powdered Latex Examination Gloves." This document does not contain information about software as a medical device (SaMD), AI/ML, or the specific types of studies, metrics, and acceptance criteria normally associated with such devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document pertains to a physical medical device (gloves) and its regulatory clearance based on substantial equivalence to predicate devices, not performance metrics derived from a study comparing algorithms or human readers.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
APL International Incorporated Limited Mr. Lee Son Hong Chief Executive Officer Go Dau Industrial Zone Long Thanh District Dong Nai Province Vietnam
Re: K033531
Trade/Device Name: Powdered Latex Examination Gloves Contains 200 Microgram or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 27, 2004 Reccived: February 9, 2004
Dear Mr. Hong:
We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in multions in accommerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the Fouch I 600; Drag, Drag, Drag, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include controls provisions annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (111) its ince can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Mr. Hong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements mean that I DA nas made a decemmand regulations administered by other Federal agencies. of the Act of any I ederal bands including, but not limited to: registration Tour must comply with an an an an any labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labeling (QS) regulation (21 CFR Part 820); and if requirences as set forth in the quarty cion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgan mading of substantial equivalence of your device to a premarket notification. - The PDF 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), If you desire specific at 110 for we at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours, .
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
APL International Incorporated Limited.
Go Dau Industrial Zone Long Thanh District Dong Nai Province Vietnam
Tel./Fax. : 0084-61543298
Indications for Use Statement
K 033531 510(K) Number (if known) : Powdered Latex Examination Gloves Device Name
Contains 200 microgram or less of total water Extractable Protein per gram
Indication For Use
A patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
| Prescription Use | |
|---|---|
| (Part 21CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marsha T. Q. Love DNCB
(Division Sign-Off) T. Regimbeech
Infection Control, Dental Devices
510(k) Number: K222621
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.