(161 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical barrier (gloves) and there is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device, "Powder-Free Nitrile Examination Gloves," is intended to prevent contamination between the patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is described as "Powder-Free Nitrile Examination Gloves," which are used to prevent contamination between patient and examiner. Its intended use is for protection, not for diagnosing any medical condition or disease.
No
The device description clearly states it is a "Powder-Free Nitrile Examination Gloves, Black," which is a physical, disposable hardware device.
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 test performed in vitro (outside the body).
- Device Description: The device is described as "Powder-Free Nitrile Examination Gloves." Gloves are a physical barrier, not a diagnostic tool.
- Lack of Diagnostic Elements: The description does not mention any components or processes related to analyzing samples (like blood, urine, tissue, etc.) or detecting specific substances or conditions.
- No Mention of IVD-Specific Information: The document lacks information typically found in IVD descriptions, such as:
- Analysis of biological samples
- Detection of analytes
- Diagnostic claims
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.)
In summary, the device is a medical glove intended for barrier protection, which falls under a different regulatory category than In Vitro Diagnostics.
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 for over-the counter use.
Product codes
LZA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Belle L. Chou Shen Wei (USA) Incorporated 33278 Central Avenue, Suite 102 Union City, California 94587
UJL = 7 2009
Re: K090194
Trade/Device Name: Powder-Free Nitrile Examination Gloves, Black Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 18, 2009 Received: June 22, 2009
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 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
Page 2 - Ms. Chou
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/
CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony V. Ancer for
Susan Runner, D.D.S., M.A.
Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Revised Attachment Two
INDICATION FOR USE
Applicant: Shen Wei (USA) Inc.
Device Name: Powder-Free Nitrile Examination Gloves, Black
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 for over-the counter use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Shala H. Murphy, L2
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090194
Prescription Use
OR
Over-The Counter
Per 21CFR 801.109
(Optional Format 1-2-96)