(58 days)
Not Found
Not Found
No
The summary describes a standard medical glove and contains no mention of AI, ML, or related technologies.
No.
A medical glove is intended for contamination prevention, not for treating a disease or medical condition.
No
The device, a medical glove, is intended to prevent contamination, not to diagnose any condition or disease.
No
The device description clearly states it is a "Powdered Synthetic Vinyl Patient Examination Gloves," 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 patients 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 is of a physical glove.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This glove does not perform such a function.
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 patient.
Product codes
LYZ
Device Description
Powdered Synthetic Vinyl Patient Examination Gloves, White
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
MAR 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kaohsiung Brothers Products Corporation C/O Mr. Chien Lin 2631 North Magnolia Street Chicago, Illinois 60614
Re: K030200
Trade/Device Name: Powdered Synthetic Vinyl Patient Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: January 15, 2003 Received: January 21, 2003
Dear Mr. Lin:
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
Page 2 - Mr. Lin
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 (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) 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). please contact the Office of Compliance 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 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 vours.
Pierce Cusimito for
Susan Runner, DDS, MA Interim 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/1 description: The image shows a black and white logo. The logo is a square with a stylized letter "B" inside. The letter "B" is made up of two horizontal bars, with the top bar slightly smaller than the bottom bar. The logo is simple and modern.
KAOHSIUNG BROTHERS PRODUCTS CORPORATION Office : 23, Kooshan 3rd Road, Kaohsiung, Taiwan, R.O.C. : 886-7-56122015 Tel : 886-7-56122067 Fax E-Mai I : sales@tehloong.com.tw
ATTACHMENT B
INDICATION FOR USE STATEMENT
510K Number (if known): ______________________________________________________________________________________________________________________________________________________ Device Name: Powdered Synthetic Vinyl Patient Examination Gloves, White
Indications For Use:
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
LONG FIRST ( XIAMEN ) PLASTICS CO., LTD.
stone chem
STONE CHEN
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR |
|---|---|
| (Per 21 CFR 801.109) | |
| (Division Sign-Off) |
General Hospital (Optional Form)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K030200
Over-The-Counter Use
(Optional Format 1-2-96)