(25 days)
Not Found
No
The summary describes a standard medical examination glove and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a glove intended to prevent contamination, not to treat a medical condition.
No
The device, an examination glove, is used to prevent contamination between patient and examiner, not to diagnose a condition or disease.
No
The device description clearly states it is a "Powder Free Natural Latex Examination Gloves," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics of the glove (material, powder-free, protein claim). This aligns with a medical device used for physical protection, not an IVD which would typically involve reagents, calibrators, or other components for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic information about a patient's health status
- Reagents, calibrators, or controls
Therefore, this device falls under the category of a general medical device used for barrier protection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and cxamincr.
Product codes
LYY
Device Description
Powder Free Natural Latex Examination Gloves with Protein Label Claim (50mcg or less EXTRACTABLE PROT)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 1999
Linga Sumarta Arista® Latindo Industrial, LTD. P.T 128 Jalan Kyai Haji Muhammad Mansyur Jakarta Barat INDONESIA 11210
K991686 Re : Trade Name: Latex Examination Gloves, Powder Free with Protein Labeling Claim, (50 mcg or less) Regulatory Class: I Product Code: LYY Dated: May 17, 1999 Received: May 17, 1999
Dear Ling Sumarta:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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.
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Page 2 — Linga Sumarta
Please note: this response to your premarket notification Ficase note: "chirot affect any obligation you might have under Submission accb 1100 as 2010 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA debeing of substantial equivalence of your device to a legally rinatig or babbomotevice results in a classification for your markets produces 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 ene promoe of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to the regulacion entitica, "Hibbranding by solors general information on your responsibilities under the Act may be Information on Jo 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
SISTA LATINDO INDUSTRIAL LTD. P.T GLOVES MANUFACTURING
OFFICE : JL. K.H. MOH. MANSYUR 120 - INDONESIA MAILING ADDRESS : P.O. BOX 4129 JKT 11041 · INDONES TELEPHONE : (021) 639-1907 (4 LINES) FAX : (62-21) 639-4691, 874-0979, 669-0428 TELEX : 42004 NIKKO 1A.
Section No. 3.
ATTACHMENT #2
INDICATIONS FOR USE STATEMENT
| Applicant: | PT. ARISTA LATINDO IND. LTD. |
|---|---|
| 510(k) Number (if known): | modification K921389 * |
| Device Name: | Powder Free Natural Latex Examination Gloves with Protein Label Claim |
| Indications For Use: | (50mcg or less EXTRACTABLE PROT |
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and cxamincr.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Usc Per 21 CFR 801.109 OR
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
(Optimal Format 1-2-96)
Basin for Oil
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -Kgg 1686