(227 days)
Not Found
Not Found
No
The device description is for examination gloves, and there is no mention of AI, ML, or any related technologies.
No.
The device is a Patient Examination Glove, intended to prevent contamination between the patient and examiner, falling under a barrier/protective function rather than a therapeutic one (i.e., treating or curing a disease or condition).
No
The device, Patient Examination Gloves, is described as a disposable device worn to prevent contamination. Its function is protective, not diagnostic. There is no mention of it being used to detect, monitor, or diagnose a disease or condition.
No
The device is described as "Patient Examination Gloves," which are physical, disposable items worn on the hand. The description focuses on material properties (latex, protein content) and physical function (preventing contamination). There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (latex), powder-free nature, and protein content, all related to the physical properties and safety of the glove for its barrier function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes
LYY
Device Description
Powder Free Latex Examination Gloves Contains 50 microgram or less of total water Extractable Protein per gram
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a circular design with the department's name encircling the outer edge. Inside the circle is a stylized emblem consisting of three overlapping, abstract shapes that resemble a human figure. The emblem is black, and the text is arranged around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2004
Mr. Lee Son Hong (Chief Executive Officer) APL International, Incorporated Limited Go Dau Industrial Zone Long Thanh District Dong Nai Province VIETNAM
Re: K033533
Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 27, 2004 Received: May 20, 2004
Dear Mr. Hong:
We have reviewed your Section 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 interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merslate commerce prives 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 approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may of buryou in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish 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 Please be advised that PDA 3 issualled on a basecures complies with other requirements mean that ITDA has made a determinations administered by other Federal agencies. of the Act of ally receial statutes and regarants, including, but not limited to: registration You must comply with an the Fee 3 requirements (art 801); good manufacturing practice and listing (21 CFR Pat 807), laooiing (21 CFR Party), 1
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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 begin maiioning your substantial equivalence of your device to a premarket notification. The PDF milling or seessification 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 advice for your de roll of the see-en 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 other general meetirs. International and Consumer Assistance at its toll-free Drimber (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
Image /page/2/Picture/17 description: The image shows a black and white close-up of a logo or symbol. The symbol appears to be a stylized design, possibly incorporating geometric shapes. The image is cropped, focusing on a portion of the symbol, and the contrast is high, emphasizing the black and white elements.
APL International Incorporated Limited.
Go Dau Industrial Zone Long Thanh District Dong Nai Province Vietnam
Tel./Fax. : 0084-61543298
Indications for Use Statement
510(K) Number (if known) : K 033533
:
Device Name
Powder Free Latex Examination Gloves Contains 50 microgram or less of total water Extractable Protein per gram
Indications 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)
Reim Muly
(Division Sign-on }
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number: K033533