(72 days)
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Not Found
No
The summary describes a standard medical glove and contains no mention of AI or ML technology.
No
Explanation: The device, "Medical disposable gloves," is described as being used to "prevent contamination" and does not claim to treat, mitigate, or prevent a disease or condition, which are characteristics of a therapeutic device.
No
A medical disposable glove is used to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is "Powdered Vinyl Synthetic Examination Gloves," which are physical hardware.
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 Function: The description clearly states the device is a glove worn on the hand to prevent contamination. It is a barrier device used externally.
- Lack of Diagnostic Activity: There is no mention of analyzing samples, detecting biomarkers, or providing any diagnostic information about a patient's health status.
The device described is a medical device, specifically a personal protective equipment (PPE), but it does not fit the definition of an IVD.
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
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Huan-Chung Li Vice President Shinemound Enterprise, Incorporated ..... 34 Linnell Circle · ''' ··· · 01821 Billerica, Massachusetts
AUG 15 1997
Re : K972104 Powdered Vinyl Synthetic Examination Gloves Trade Name: Requlatory Class: I Product Code: r və qalında və qalında qalında qalında qalında qalında qalında qalında qalında qalında qalında qalında qalında qalarında qalarında qalarında qalarında qalarında qalarında q Dated: July 25, 1997 Received: August 1, 1997
. . . . .
Dear Mr. Huan-Chung Li:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 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 obligation you might have under sections 531
1
Page 2 - Mr. Huan-Chung Li
through 542 of the Act for devices under the Electronic chrough 512 or on the ol 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 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 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,
K. C. Matoush.
y A. Ulatowski Timoth Directbr 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 a logo with the letters 'S' and 'M' stacked on top of 'Inc' inside an oval. A horizontal line extends from the right side of the 'M', adding a design element to the logo. The logo appears to be for a company or organization named 'SM Inc'.
Shinemound Enterprise Inc.
34 LINNELL CIRCLE, BILLERICA, MASSACHUSETTS 01821 Fax (508) 957-7318/436-9983 TEL (508) 436-9980
Attachment 1
1
Indication For Use Statement - - - ------------
510K Number(if known): K972104
Device Name: Powdered Vinyl Synthetic Examination Gloves
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,
ﻢ
Piherechagi
QS
Huan-Chung Li Vice President Shinemound Enterprise, Inc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972104 |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |
| Prescription Use (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use X |
(Optional Format 1-2-96)