(15 days)
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Not Found
No
The device description and intended use clearly define a standard examination glove, with no mention of AI/ML or related technologies.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to treat or diagnose a disease or condition.
No
The device is a glove worn to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a "Powdered Latex Examination Glove," 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 hand or finger to prevent contamination. This is a physical barrier device used in vivo (on a living person), not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description confirms it's a glove.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are typically used to perform tests on samples taken from the body to diagnose diseases, monitor health, or determine treatment options. This glove does not perform such a function.
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
LYY
Device Description
Powdered Latex Examination Gloves Without Protein Content Labelling Claim
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand or finger
Indicated Patient Age Range
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Intended User / Care Setting
Examiner (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.)
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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
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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 & 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 an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2001
Ms. Selina Segaran Managing Director Seltom Pacific Sdn. Bhd. Lot 25, Jalan PJS 7/17 Sunway Industrial Park 46150 Petaling Jaya, Selangor, MALAYSIA
K011922 Re : Powdered Latex Examination Gloves Trade/Device Name: Requlation Number: 880.6250 Requlatory Class: I Product Code: LYY Dated: June 15, 2001 Received: June 20, 2001
Dear Ms. Segaran:
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 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). 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 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 Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to
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Page 2 - Ms. Segaran
comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. action. In addition, TBA may passible gransal Register. Please note: this response to your premarket notification submission does this response to your premarked hove under sections 531 not arress any one act for devices under the Electronic through 542 or the net 10- control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your six (w) quivalence of your device to a legally Finding of bubbeancear of classification for your marketed prodicate abouts your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regardiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che Dromotion and Compliance at (301) 594-4639. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be
Informacion on Jour wision of Small Manufacturers Assistance obcation from one (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
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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Page 1 of 1
Pacific Firm : Selfom Son . Bhd.
510 (k) Number (if known) : _ KO 11922
Device Name: Powdered Latex Examination Gloves Without Protein Content Labelling Claim
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
Qain S. lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .
(Optional Format 1-2-96)