(40 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard medical glove, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device, a medical glove, is primarily for preventing contamination between healthcare personnel and patients, not for treating a disease or condition.
No
Explanation: The device is a medical glove, which is used to prevent contamination between healthcare personnel and patients. Its intended use does not involve diagnosing any medical condition or disease.
No
The device description clearly states it is a "medical glove," which is a physical hardware product, not software.
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 healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details a glove with specific material and protein content. This aligns with a physical barrier device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- No Mention of IVD-Specific Information: The provided fields do not include information typically associated with IVDs, such as sample types, analytes, or performance metrics related to diagnostic accuracy.
In summary, the device is a medical glove intended for barrier protection, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Product codes
LYY
Device Description
Powder Free Latex Patient Examination Gloves with Aloe Vera and Protein Content Labeling Claim of 50 Micrograms 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2001
Matang Manufacturing Sdn. Bhd. C/O Mr. Kok-Kee Hon Official Correspondent 6324 Meeting House Way Alexandria, Virginia 22312-1718
Re: K012558
Trade/Device Name: Powder Free Latex Patient Examination Gloves with Aloe Vera and Protein Content Labeling Claim of 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: August 7, 2001 Received: August 8, 2001
Dear Mr. Hon:
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 Amendments, 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 approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device 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
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,
K. Milatovic
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Image /page/2/Picture/0 description: The image shows a logo with the word "MATANG" in bold, block letters at the bottom. Above the word is a circle containing a stylized image of a horse rearing up on its hind legs. The horse is black and appears to be a silhouette.
APPENDIX 2
INDICATIONS FOR USE
Applicant:
MATANG MANUFACTURING SDN. BHD.
510 (k) Number (If known) : |(12558
Device Name:
Matang Powder-Free Latex Patient Examination Gloves with Matang - San Protein Content Labeling Claim of 50 Micrograms or less of total water extractable protein per gram.
Indications For Use:
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
OR
| Prescription Use ----------- | |
|---|---|
| Per 21 CFR 801.109 |
Over-The-Counter
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital,Device 510(k) Number