(59 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical barrier (gloves) with no mention of software, data processing, or AI/ML terms.
No
Explanation: The device, disposable examination gloves, is intended to prevent contamination between patient and examiner. It does not treat or alleviate a disease, injury, or disability.
No
Explanation: The device is described as an "Examination Glove" intended to prevent contamination, not to diagnose any medical condition.
No
The device description clearly states it is a "Disposable Powder Free Vinyl Synthetic Examination Gloves," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of this device is to prevent contamination between a patient and an examiner by being worn on the examiner's hand. This is a physical barrier function, not a diagnostic test performed on a specimen.
- Device Description: The description confirms it's a disposable glove, which aligns with its intended use as a physical barrier.
The information provided clearly indicates the device's purpose is for infection control through a physical barrier, not for performing diagnostic tests on biological samples.
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.
This device is not intended to be used as a chemical barrier.
Product codes
LYZ
Device Description
Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows the seal for the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2004
Ms. Cynthia Liu Service Marketing Manager Shen Wei (USA), Incorporated 2845 Whipple Road Union City, California 94587
Re: K033539
Trade/Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: 1 Product Code: LYZ Dated: November 7, 2003 Reccived: November 10, 2003
Dear Ms. Liu
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 approvisions 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 (1 112 ), it insy 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
Page 2 -Ms. Liu
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 modi that I Dr I may made statutes and regulations administered by other Federal agencies. or the Act of ally I oderal bakers an requirements, including, but not limited to: registration I ou must compry with arrary with and 11 CFR Part 801); good manufacturing practice and listing (21 OF R Parvov), areality systems (QS) regulation (21 CFR Part 820); and if requirements to be form nroduct 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) I mis letter will and it your end finding of substantial equivalence of your device to a premaired 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), n you donte specific at at Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entired, which and information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qus
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
2
Image /page/2/Picture/0 description: The image is a black and white abstract design. The right side of the image has a thick, curved black shape. The left side of the image has a smaller, more jagged black shape. The rest of the image is white.
Koz 3539
Attachment Two
INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color Device Name:
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.
This device is not intended to be used as a chemical barrier.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluàtion (ODE)
Antoinette Dg. Biler-Berndorf 1-8-64
esthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K033539
Prescription Use Per 21CFR 801.109 ાર
Over the Counter
(Optional Format 1-2-96)
(4)