(72 days)
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No
The summary describes a standard examination glove and contains no mention of AI or ML technology.
No
The device is described as an examination glove used to prevent contamination, which is a barrier function, not a therapeutic intervention.
No
Explanation: This device is described as an examination glove used to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (gloves) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to be worn on the hand of healthcare personnel to prevent contamination. It does not involve the examination of any biological specimens.
- The device description and intended use clearly define it as a barrier device. Its function is to create a physical barrier between the user and the patient.
- There is no mention of any diagnostic purpose or analysis of biological samples.
Therefore, based on the provided information, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is worn on the hand of healthcare and similar personnel to prevent containination between healthcare personnel and the patient
Product codes
LYY
Device Description
Powder Free Latex Examination Gloves, Polymer Coated With Protein Content Labeling Claim (50 Micrograms or Less)
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
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Indicated Patient Age Range
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Intended User / Care Settin
healthcare and similar personnel
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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 stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 1999
Mr. Shukur Hasran QA/QC Officer Biografik (Malaysia) Sdn. Bhd. PT No. 3307 Jalan AM 1 Arab-Malaysian Industrial Park 71800 Nilai, Negeri Semblian DK, Malaysia
Re : K ਕੇ ਕੇ 3 ਦੇ 2 ਕ Trade Name: Powder Free Latex Examination Gloves, Polymer Coated With Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: October 12, 1999 Received: October 18, 1999
Dear Mr. Hasran:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
1
Page: 2 -Mr. Hasran
the Federal Register. Please note: this response to your : remarket 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.
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 regulation (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 qeneral information on your responsibilities under the Act may be oblained 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,
Liesel W. Sheppard
form Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ATTACHMENT 2
INDICATION FOR USE STATEMENT
| Applicant | Biografik (Malaysia) Sdn Bhd |
|---|---|
| 510(K) | K993529 |
| Device Name : | Powder Free Latex Examination Gloves, Non-Sterile, Polymer Coated WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
Indication for use
A patient examination glove is worn on the hand of healthcare and similar personnel to prevent containination between healthcare personnel and the patient
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of SDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ଠାର
Over-The-Counter V
Sanuteeum for Chuchin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dey 510(k) Number _