(55 days)
Not Found
Not Found
No
The summary describes a disposable glove and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device, disposable gloves, is primarily used for protection and contamination prevention, not for treating or preventing disease in the patient.
No
Explanation: The device described is a medical disposable glove, which is used to prevent contamination. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical product (disposable gloves) and does not mention any software components.
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 healthcare personnel and patients by being worn on the hand. This is a barrier function, not a diagnostic function.
- Device Description: The description is of a physical barrier (gloves).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Using reagents or instruments to perform tests on samples.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. Disposable gloves are a physical barrier used on the body to prevent the spread of contamination.
N/A
Intended Use / Indications for Use
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Product codes
LYZ
Device Description
Disposable Powdered Vinyl Synthetic Examination Gloves, Beige color (Sensi-Pro)
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
healthcare and similar personnel
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/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 FEB
Mr. Gui-Xi Liu General Manager Shijiazhuang Hongray Plastic Products Company, Ltd. No. 135 Xinhua West Road Shijiazhuang City, Hebei Province, China
Re : K994206 Trade Name: Disposable Powdered Vinyl Synthetic Examination Gloves, Beige Color (Brand Name: Sensi-Pro) Requlatory Class: I Product Code: LYZ Dated: August 8, 1999 Received: December 14, 1999
Dear Mr. Liu:
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, Druq, 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 misbrandinq 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 Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
1
Page 2 - Mr. Liu
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
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
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
No. 135 Xinhua West Road, Shijiazhuang City, Hebei Province, China Tel: 86-311-3613127 3634449 Fax: 86-311-3634221 Attachment G Email: hongray@public.sj.he.cn
Indication For Use
| Applicant: | Gui-Xi Liu, Shijiazhuang Hongray Plastic Products Co., LTD. |
|---|---|
| ------------ | ------------------------------------------------------------- |
K994206 510K Number(if known):
Device Name: Disposable Powdered Vinyl Synthetic Examination Gloves, Beige color (Sensi-Pro)
Indication For Use:
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Truthfully Yours,
之農去
Gui-Xi Liu General Manager
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use X |
|---|---|---|
| --------------------------------------- | ---- | ------------------------ |
| (Division Sign-Off) | |
|---|---|
| --------------------- | ------- |
(Optional Format 1-2-96)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K994206 |
|---|---|
| --------------- | --------------- |