(154 days)
Not Found
Not Found
No
The 510(k) summary describes a simple medical glove and contains no mention of AI, ML, or any related technologies.
No
The device, an examination glove, is intended for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is an examination glove, intended to prevent contamination. It does not collect or analyze data to inform a medical diagnosis.
No
The device is a physical glove, not software. The description clearly states it is a "Powder-Free Hypoallergenic Nitrile Examination Glove".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Intended Use: The intended use of this device is clearly stated as a "disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device used for infection control.
- Lack of Diagnostic Function: The description does not mention any testing of biological samples or any diagnostic function. Its purpose is purely protective.
Therefore, based on the provided information, the Powder-Free Hypoallergenic Nitrile Examination Glove is a medical device, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Powder-Free Hypoallergenic Nitrile Examination Glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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): 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.
Not Found
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
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/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Belle Chou Director Shen Wei (USA), Incorporated 2845 Whipple Road Union City, California 94587
NOV - 5 1997
K972090 Re: Blue Powder-Free Hypoallergenic Nitrile Trade Name: Examination Gloves Regulatory Class: Product Code: LZA Dated: August 27, 1997 September 4, 1997 Received:
Dear Mr. Chou:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of A Federal Requlations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Belle
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 general information on your responsibilities under the Act may be obtained 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,
Palocci Cucentoffa
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
Image /page/2/Picture/0 description: The image shows the logo for Shen Wei (USA) Inc. The logo consists of the letters "SW" inside a double-lined square. To the right of the square is the text "Shen Wei (USA) Inc."
Attachment One
2845 Whipple Road . Union City, CA 94587 . Phone (510) 429-8692 . Fax (510) 487-5347
INDICATIONS FOR USE
| Applicant: | Shen Wei (USA) Inc. |
|---|---|
| 510(k) Number: | K 972090 |
| Device Name: | Powder-Free Hypoallergenic Nitrile Examination Gloves |
| Indications For Use: | Powder-Free Hypoallergenic Nitrile Examination Glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Clim S. Lim
(Division Sign Division of De and General Ho 510(k) Number
Prescription for Use Per 21 CFR 801.109
OR
Over-The-Counter X
(Optional Format 1-2-96)