(168 days)
Not Found
Not Found
No
The 510(k) summary describes a patient examination glove, a simple barrier device, and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a disposable glove worn to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one.
No
Explanation: The device is described as a "patient examination gloves," which are used to prevent contamination between patient and examiner. This function does not involve diagnosing medical conditions, but rather providing a barrier.
No
The device is described as a physical glove worn on the hand or finger, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination. This is a physical barrier device used during patient examination.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The description of the gloves does not involve any such testing or analysis of biological samples.
- Anatomical Site: The anatomical site is the "hand or finger," which is where the device is worn, not where a diagnostic test is performed.
Therefore, a patient examination glove falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination gloves 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
UNIJECT PATIENT EXAMINATION GLOVES
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 1997
Dr. Syed Baber Uniject Gloves Ltd. 2920 Mumphrey Drive -Chal Mette, Louisiana 70043
Re : K970191 Uniject Latex Examination Gloves (Powdered) Trade Name: Requlatory Class: I Product Code: LYY Dated: April 29, 1997 Received: May 1, 1997
Dear Dr. Baber:
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 Regulations, Title 21, Parts 800 to 895. ਬ 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Dr. Baber
through 542 of the Act for devices under the Electronic emrough Siz OF on 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) 594-4618. 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.fida.gov/cdrh/dsmamain.html".
Sincerely yours,
Clitatoust
Ulatowski Timo ny Director 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 the logo for "UNIJECT GLOVES LTD." The logo consists of the company name in a stylized font, with the first word in a slightly larger font size. Above the company name is the same name in Arabic. To the left of the company name is a circular emblem containing a hand.
Jだ38L ・・・・・・・・・・・・・・・
ాంగ్లా ప్రాచారు. ప్రాచారు. ప్రాచారు సంరక్షణ నిర్మాలు సంరక్షణ నిర్మాల సంరక్షణ కాలు గ్రామం నుండి గ్రామం నుండి నుండి నా గ్రామం నుండి
INCORPORATED IN BR'TISH VIRGIN :SLAND .
INDICATIONS FOR USE
| Applicant | : UNIJECT GLOVES LTD; JEBEL ALI, DUBAI (U.A.E) |
|---|---|
| 510 K Number | : K 9700191 |
| Device Name | : UNIJECT PATIENT EXAMINATION GLOVES |
| Indications for use | : A patient examination gloves 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) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K970191 |
| Prescription Use
| Per 21 CFR 801, 109 | OR | Over-The-Counter | X |
|---|---|---|---|
| ----------------------------------------- | ---- | ------------------ | ----------------------------------------- |
(Optional Format 1-2-96)ﺘﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
P.O. BOX 16901, JEBEL ALI, DUBAI - U.A.E. TEL. : 00971-4-815235 FAX. : 00971-4-815232
صوب : 1 . ا ٦٩٠١ . حمل تعلى . دلى ساء .ع.ه. ﺘﻠﯿﻐﻮﻥ : ۹۳۵۵۱۱۵-۱۰۹۷۱ ﻓﺎﮐﺲ :