(50 days)
Not Found
Not Found
No
The summary describes a standard patient examination glove with no mention of AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The provided text describes a patient examination glove as a disposable device intended for preventing contamination, not for treating a condition or disease.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove, 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 patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is of a physical glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that definition.
N/A
Intended Use / Indications for Use
A 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.
Product codes
LZA
Device Description
Nitrile Patient Examination Glove, Powder-free and yellowish white
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
medical purposes
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, enclosed in a circle. The text "HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2002
Formosa Glove Industrial Company Limited C/O Dr. Tiang S. Chang 1016 Seward Avenue Westfield, New Jersey 07090
Re: K014284
Trade/Device Name: Nitrile Patient Examination Gloves, Powder-Free and Yellowish White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: December 22, 2001 Received: December 27, 2001
Dear Dr. Chang:
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.
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.
1
Page 2 - Dr. Chang
You must comply with all the Act's requirements, including, but not limited to: registration You must colliply with an the Act 5 required (21 CFR Part 801); good manufacturing practices and listing (21 CFR Pat 607), laceming (21 CFR Pat 820) 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 1 his letter will anow you to begin marketing your substantial equivalence of your device to 510(K) premiarket nothleation. The PBPICation 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 & in vitro diagnostic devices), please contact the and additionally 21 CFR Fall 607.10 Ion in the onelly, for questions on the promotion and Office of Comphance at (301) 391 - 11 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - - 639. advertising or your arritled, "Misbranding by reference to premarket Also, picase note the regulation one other general information on your responsibilities under notification (21CF ICPart 007.97). Oaks got Small Manufacturers, International and the Act may be obtained from the DPH.orger (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Chena-Ch nin-Ya 1.hinet.net
Indications for Use
Formosa Glove Industrial Co., Ltd. Applicant:
KO14294 510(k) Number (if known):
Device Name: Nitrile Patient Examination Glove, Powder-free and vellowish white
Indications for Use:
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR
Over the Counter Use
(Optional Format 1-2-96)
Olim S. Lin
്തിടion Sign-Off) Asion of Dental, Infection Control, General Hospital Devic ""(k) Number .
FACTORY:NO.10-8,MA-KUO-LI,MATOU TOWN,TAINAN HSIEN,TAIWAN,R.O.C. 1061570-1885-6 FAX 1061570-0388