(128 days)
Not Found
None
No
The 510(k) summary describes a standard medical glove and contains no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a protective function, not a therapeutic one (i.e., it doesn't treat or cure a disease).
No
This device is a glove, intended to prevent contamination between a patient and an examiner. It does not perform any diagnostic function.
No
The device is a physical glove, 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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the glove is worn on the hand or finger to prevent contamination between patient and examiner. It acts as a physical barrier.
- Lack of Diagnostic Function: The glove itself does not analyze any biological samples or provide any diagnostic information about the patient's health.
The device described is a medical device, specifically a personal protective equipment (PPE), but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A patient Examination Powder glove sterile 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 patient Examination Powder-Free Chlorinated glove sterile 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
LYY
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)
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 logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 6 1999
Ms. Danielle Cottet Quality Controller Wear Safe Malaysia Sdn. Bhd. Lot 1, Leboh Hishamuddin Satu North Klang Straits Industrial Area 42000 Port Klanq Selangor Darul Ehsan, West Malaysia
K992681 Re : Patient Latex Examination Glove Powdered & Trade Name: Powder-Free, Sterile Requlatory Class: I Product Code: LYY November 25, 1999 Dated: Received: December 2, 1999
Dear Ms. Cottet:
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 qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Federal Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
1
Page 2 - Ms. Cottet
the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 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 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Rummer
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
1992681 510 (k) Number (if known) : Device Name : PATIENT EXAMINATION "POWDER" GLOVES STERILE Later Indications For Use :
A patient Examination Powder glove sterile 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)
Qur Ln
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Device 510(k) Number
3
Image /page/3/Picture/0 description: The image shows the logo for WSM Wear Safe Malaysia. The logo consists of the letters WSM in large, bold font, with the words "WEAR SAFE MALAYSIA" underneath. To the right of the letters is a symbol that looks like a plus sign inside of a square. The text below the logo states that the company was formerly known as WUHRLIN SOPLAMED (M) SDN. BHD., and the text to the right of the logo states SDN. BHD. (20439.
Page 01 of 01
K992681 510 (k) Number (if known) : Device Name : PATIENT EXAMINATION "POWDER-FREE" GLOVES STERILE Indications For Use :
★ A patient Examination Powder-Free Chlorinated glove sterile 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)
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hosp 510(k) Number