(227 days)
Not Found
Not Found
No
The 510(k) summary describes a disposable patient examination glove, which is a simple barrier device and does not involve any computational or analytical functions that would utilize AI or ML. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a patient examination glove, which is a barrier for protection and not used to treat or diagnose a disease or condition.
No
The device is described as a glove for protection against contamination during patient examination, not for diagnosing medical conditions.
No
The device 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 for protection against contamination during patient examination. 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, not a reagent, instrument, or software used for analyzing biological samples.
- Lack of IVD Characteristics: The document lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The device is a disposable patient examination glove made of synthetic rubber intended for medical purposes. It is donned by the user as protection against possible contamination when examining a patient.
Product codes
LZA
Device Description
Powder-Free Colored (White, Pink, Blue, Green) and Flavored (Strawberry, Tutti-Fruity and Peppermint) Chloroprene Patient Examination Glove
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1998 NOV
Mr. Anil Taneja General Manger Pt. Irama Dinamika Latex Jl. Kapten Pattimura No. 23/235 Medan 20153 INDONESIA
Re: K981064 Trade Name: Powder-Free Colored (White, Pink, Blue Green) and Flavored (Strawberry, Tutti-Fruity and Peppermint) Chloroprene Patient Examination Glove Regulatory Class: I Product Code: LZA September 28, 1998 Dated: October 1, 1998 Received:
Dear Mr. Taneja:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Taneja
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours, Susas Kursan Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a black and white abstract design. The design consists of a square in the upper left corner, a vertical rectangle in the middle, and another vertical rectangle on the right. The middle rectangle is connected to a horizontal rectangle that extends to the left, creating a unique shape.
K#981064
PT. IRAMA DINAMIKA LATEX Jl. Kapten Pattimura No. 23 / 235, Medan - 20153,Indonesia PHONE : (62-061) 515-834; 576-502; FAX: 553-389 e-mail : ptirama@indosat.net.id
ATTACHMENT # 1
INDICATION FOR USE
| Applicant | : PT Irama Dinamika Latex |
|---|---|
| Device | : Powderfree Chloroprene Flavored and Colored Patient Examination Gloves |
| Indication for use: | The device is a disposable patient examination glove made of synthetic |
| rubber intended for medical purposes. It is donned by the user as | |
| protection against possible contamination when examining a patient. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_ X
(Optional Format 1-2-96)
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