(20 days)
Not Found
No
The summary describes a disposable medical glove and does not mention any AI or ML capabilities.
No.
The intended use of the device is for contamination prevention between patient and examiner, not for treating or diagnosing a medical condition.
No
The device, a glove, is intended for preventing contamination, 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 "hand to prevent contamination between patient and examiner." This describes a barrier function for infection control, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "Powder Free Nitrile Examination Glove with Peppermint Flavor." This is a physical barrier device, not a reagent, instrument, or system intended for the diagnosis of disease or other conditions.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of disease or other conditions. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Page 3 of 39
3.0 Indication for Use Statement:
INDICATION FOR USE
| Applicant: | PT. SMART GLOVE INDONESIA |
|---|---|
| 510(k) Number: Applied for | K030406 |
| Device Name: | Powder Free Nitrile Examination Gloves with Peppermint Flavor |
Indication For Use:
This glove is disposable and intended for medical purpose that is ============================================================================================================ hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Powder Free Nitrile Examination Gloves with Peppermint Flavor
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
medical purpose
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): 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.
Not Found
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.
Not Found
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).
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three flowing lines representing the body, head, and arms. The figure is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2003
Mr. Foo Khon Pu Pt. Smart Glove Indonesia Jl. Pelita Raya No. 5 - 7 Kawasan Industri Medan Star Jl. Raya Medan, Lubuk Pakam Km. 19. Tg Marowa B-Tg. Marowa Deli Serdang, 20362 Sumatera Utara, INDONESIA
Re: K030406
Trade/Device Name: Powder Free Nitrile Examination Gloves with Peppermint Flavor Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: January 31, 2003 Received: February 3, 2003
Dear Mr. Khon Pu:
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 vour 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. Khon Pu
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 yours,
Susan Runyon
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
GLOVE INDONESIA
Page 3 of 39
3.0 Indication for Use Statement:
INDICATION FOR USE
| Applicant: | PT. SMART GLOVE INDONESIA |
|---|---|
| 510(k) Number: Applied for | K030406 |
| Device Name: | Powder Free Nitrile Examination Gloves with Peppermint Flavor |
Indication For Use:
This glove is disposable and intended for medical purpose that is ============================================================================================================ hand 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 (Optional i ormat 1-2-96)
Qilin S. Lahn
(Division Sign-Off) Division of Anesthesiology, Infection Control, D
510(k) Number. K 030406