(163 days)
Not Found
No
The 510(k) summary describes a simple medical glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a preventive measure rather than a treatment for a disease or condition.
No
The device is described as a glove worn on the hand or finger to prevent contamination, which is a protective barrier function, not a diagnostic one.
No
The device is described as a "patient Examination Powder glove," which is a physical, disposable device worn on the hand. This clearly indicates a hardware component and not a software-only 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 or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic activity.
- No Mention of IVD-related terms: The document does not contain any terms typically associated with IVDs, such as "assay," "reagent," "sample," "analysis," "diagnosis," etc.
Therefore, a patient examination powder glove, as described, falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient Examination Powder 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.
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 or finger
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): 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.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
JUN 9 - 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Danielle Cottet Quality Controller Wear Safe Malaysia Sdn. Bhd. Lot 1, Leboh Hishamuddin Satu, North Klang Straits Industrial Area 42000 Port Klang Selangor Darul Ehsan, West Malaysia
Re : K992675 Trade Name: Patient Exam Nitrile Powdered Gloves Regulatory Class: I Product Code: LZA Dated: November 25, 1999 Received: December 2, 1999
Dear Ms. Cottet:
This letter corrects our substantially equivalent letter of January 20, 2000, regarding the Device Name and the Product Code .
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 cnclosure) 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 of the Act. The general controls goncrols 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part B20) 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 Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Ms. Cottet
the Act for devices under the Electronic Product Radiation the Act for devices under the Bicercher Federal laws or regulations.
This letter will allow you to begin marketing your device as the FDA This letter will allow you co began notification. The FDA described in your 510(x) piemarke no revice to a legally
finding of substantial equivalence of your alagafication for your finding of substantial equivalence of yoursefication for your marketed predicate device resures in a oraceae.
device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice for gittionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulacion (21 cm Fare 301 and contact the Office of vitro diagnostic devices), prease concastly, for questions on
Compliance at (301) 594-4692. Additionally, for quese contact Compliance at (301) 594-4692. Andressdevice, please contact
the promotion and advertising of your as 430. Algo, please not the promotion and advertising or (301) 594-4639. Also, please note of the Office of Complance at (1301) 334 1037 - 1057 - 100 - 1 premarket notification - (2) cir circles under the Act may be information on your responsibilities unusi- eurers Assistance
obtained from the Division of Small Manufacturers Assist or a obtained from the Division of Smart March (301) 443 6597 or at
at its toll-free number (800) 638-2041 acculdade/dsmamain html", at its toll-tree number (800) 636 2041 Of (600) *** its internet address ".
its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William
Timothy A. Ulat Director Director 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 a logo with the letters "WSM" in large, bold font. Below the letters, the words "WEAR SAFE MALAYSIA" are printed in a smaller font. To the right of the letters is a symbol resembling a plus sign or a four-way intersection. The text "SON. BHD P204396-X)" is located to the right of the symbol. The text "Formerly known as WUHRUN SOPLAMED (M) SDN. BHD.)" is printed in a small font below the words "WEAR SAFE MALAYSIA".
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15992675 510 (k) Number (if known) : Device Name : PATIENT EXAMINATION "POWDER" GLOVES , N 14e il C Indications For Use :
- A patient Examination Powder 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Presription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K992687 (K992675 |