(64 days)
Not Found
Not Found
No
The device is a medical examination glove, and the summary contains no mention of AI, ML, or any related technologies.
No.
The device is described as a medical examination glove, which is used to prevent contamination, not to treat a condition or disease.
No
Explanation: The device is described as a "medical examination glove" used to "prevent contamination between health care personnel and the patient," which is a protective barrier function, not a diagnostic one.
No
The device description clearly states it is a physical glove, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is to be worn on the hand of healthcare personnel to prevent contamination. It does not involve the examination of any biological specimens.
- IVDs are used to provide information for diagnosis, monitoring, or treatment. This glove's purpose is a barrier for infection control, not to provide diagnostic or treatment information.
The description clearly indicates a medical examination glove, which is a Class I or Class II medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LYY
Device Description
Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or less)
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
health care 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
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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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Mr. Stanley Thai Managing Director Supermax Latex Products Sdn. Bhd. Lot #42, Putra Industrial Park Bukit Rahman Putra 47000 Sungai Buloh, Selangor Darul Ehsan Malaysia
K980071 Re : Superqloves Powder Free Latex Examination Trade Name: Gloves with Protein Content Labeling Claim (50 micrograms or Less) Requlatory Class: I Product Code: LYY Dated: January 5, 1998 January 8, 1998 Received:
Dear Mr. Thai:
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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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.
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Page 2 - Mr. Thai
concerning your device in 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 enrough 342 or che 180 row some of 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) 594-4618. 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 requlation entitled, "Misbranding by reference to oremarket 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,
Timothy R. Ulatuski
Timi thy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
| Applicant : | Supermax Glove Manufacturing Sdn Bhd |
|---|---|
| 510(k) Number (if known) : | K980071 |
| Device Name : | Powder Free Latex Examination Gloves with Protein Content Labeling Claim |
| (50 micrograms or less) |
Indications For Use :
: 中
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number |
Prescription Use ............................................................................................................................................................. Por 21 CFR 801.109
(Optional Formal 1-2-96)