(69 days)
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No
The device description and intended use clearly define a physical barrier (gloves) and there is no mention of AI/ML terms or related concepts like image processing, training/test sets, or performance metrics associated with algorithmic analysis.
No
The device is described as a glove intended to prevent contamination between patient and examiner, which is a protective barrier function, not a therapeutic intervention.
No
The device is described as "Powder-Free Latex Examination Gloves," which are used for preventing contamination, not for diagnosing medical conditions.
No
The device is described as a "disposable device" and "Powder-Free Latex Examination Gloves," which are physical hardware components, 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 to prevent contamination between patient and examiner by being worn on the hand. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details examination gloves, which are a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs
Product codes
LYY
Device Description
Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
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 Setting
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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): 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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 with three wavy lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Ms. Belle L. Chou General Manager Shen Wei (USA), Incorporated 2845 Whipple Road Union City, California 94587
Re: K013794
Trade/Device Name: Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 10, 2001 Received: November 14, 2001
Dear Ms. Chou:
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.
1
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 mount that I be any Federal statutes and regulations administered by other Federal agencies. or the receingly with all the Act's requirements, including, but not limited to: registration r od intiles compty was a807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelies 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 lottor will and if you to began 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 rr you desire upo 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and 1301 - 630 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Allachment Two
INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
Device Name: Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Powder-Free Latex Examination Sloves Min Floor and From one I css. of Ford.
Use with Chemotherapy Drugs Control of Conformations of I essea of Ford brags extractable Professo
Indication For Use:
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Olin Sn Lim
IDivision Sign-Off) Division of Dental, Infection Control, and General Hospital Devi E 1 (k) Number .
Prescription Use Per 21CFR 801.109 OR
Over-The Counter (Optional Formal 1-2-96)