(48 days)
Not Found
Not Found
No
The 510(k) summary describes a standard medical glove and contains no mention of AI or ML technology.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat any medical condition or restore health.
No
Explanation: The device, a patient examination glove, is described as preventing contamination between patient and examiner. Its intended use is not for diagnosing a condition or disease.
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 clearly states the device is a "patient examination glove...worn upon the examiner's hands or finger to prevent contamination between patient and examiner." This describes a physical barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Description: The description details the physical characteristics of the glove (material, color, coating, protein content). This aligns with a physical barrier device.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but not an in vitro diagnostic device.
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 hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Product codes
LYY
Device Description
DERMAGRIP-G AND MULTIPLE CUSTOMER TRADE NAME GREEN COLOR, ALOE VERA COATED, LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS WATER EXTRACTABLE PROTEIN)
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
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
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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.)
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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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and freedom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2004
Mr. Terence Lim Associate Manager, Quality Assurance Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang, Selangor Darul Ehsan MALAYSIA
Re: K040645
Trade/Device Name: Dermagrip-G and Multiple Customers Trade name Green Color, Aloe Vera Coated Latex Examination Gloves With Proteen Content Labeling Claim (50 Micrograms or Less Water Extractable Protein) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: March 9, 2004 Received: March 11, 2004
Dear Mr. Lim:
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 your 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.
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Page 2 - Mr. Lim
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,
Chia-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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WRP Asia Pacific Sdn Bhd
$
Indications for Use
310(k) Number (if known).
Devise Name - DERMAGRIP-G AND MULTIPLE CUSTOMER TRADE NAME GREEN COLOR, ALOE VERA COATED, LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM ($0 MICROGRAMS OR LESS WATER EXTRACTABLE PROTEIN)
traications For Use
A patient examination glove is a disposable device intended for mediest proposes that is worn ut The examiner's hands or firstar to prevent continuition beliveren patient and exadion. (21CFR 880 6250)
Preseription Use (Pro 21 CFR 80) Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subgari (8).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANUTHER PAGE IP NEEDED
Concertifica of CDRH, Office of Device Evidention (ODE)
- And 11:10:00 PM IST 11:00 PM IS 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM
Kevin Mulvey
(Division Sign-Off) Division of Anesthesiology, General Hosp tion Control, Dental Devices
510(k) Number: K040645
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