(45 days)
Not Found
Not Found
No
The summary describes standard examination gloves and contains no mention of AI or ML technology.
No
The device, "Pre-Powdered Patient Examination Gloves," is intended to prevent contamination, not to provide therapy, treatment, or cure for a disease or condition.
No
Gloves are used for protection and hygiene, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (gloves) and does not mention any software component.
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 hands or fingers. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (latex), form (pre-powdered), and protein content of the gloves. It doesn't describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pre-Powdered Patient Examination Gloves is a disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
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
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Key Metrics
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.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle's body is formed by three curved lines, and its tail is represented by two wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2001
Mr. Lim Weng Heng Factory Manager Koon Seng Sdn Bhd PTD 3274 Batu 4 1/2 Jalan Bakri Muar Johor, MALAYSIA
Re: K013537
Trade/Device Name: Royal Imperial Powdered Latex Examination Gloves with Protein Control Labeling Claim ( 200 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 23, 2001 Received: October 23, 2001
Dear Mr. Heng:
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 Antichunches, or to de rises 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (1 Nr. ), it may 80 casyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issualled of a bases and institution the became is a mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally Federal statutes and regulations, but not limited to: registration You must colliply with an the Fec 3 requires (21 CFR Part 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 800); and i and listing (21 CFR I art 607), lacems (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 This letter will and w you to begin manteening your of substantial equivalence of your device to 510(K) premarket nothleadon: "The Fesults 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 II you desire specific ad rise 10. Join in vitro diagnostic devices), please contact the and additionally 21 CFR rar. 6091-4618. Additionally, for questions on the promotion and Office of Comphiance at (301) 39 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . advertising of your avrited, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notification (210) it it all 00197).
the Act may be obtained from the Division of Small Manufacturers, 1984 - 1997 the Act may be obtained nom and Benumber (800) 638-2041 or (301) 443-6597 or at its Consumer / issistance at ho vov - fda gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Rl. Allatord
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use Statement : Include the following or equivalent for Use page. The 3.0 information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE.
| Applicant : | Koon Seng Sdn. Bhd. |
|---|---|
| 510 (k) Number (if known): | K 013537 |
| Device Name: | ROYAL IMPERIAL LATEX Pre-Powdered Patient Examination Gloves WITH PROTEIN CONTENT |
| Indications For Use: | LABELING CLAIM (200 MICROGRAMS OR LESS) Pre-Powdered Patient Examination Gloves is a disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner. |
(PLEASE IDO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH Office of Device Evaluation ( ODE)
Qiu S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use Per 21 CFR S 01.109 ાર
Over - The - counter _____________
(Eq. 1.6)
- For a new submission, do NOT fill in the 510(k) number blank
(Optional Format 1-2-96)