(168 days)
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,
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This document is a 510(k) premarket notification letter from the FDA regarding "Uniject Latex Examination Gloves (Powdered)." It confirms that the device is substantially equivalent to legally marketed predicate devices.
No acceptance criteria or study details are provided in the document.
The document primarily focuses on the regulatory approval of the gloves based on substantial equivalence. It does not contain information about:
- Acceptance criteria table or reported device performance: This document explicitly states substantial equivalence, which means the device performs as well as an already-approved predicate device. It doesn't present specific performance metrics or acceptance criteria for those metrics.
- Sample size for the test set or data provenance: No performance testing data is presented or referenced.
- Number of experts and qualifications for ground truth: Not applicable as no specific study data requiring ground truth establishment is detailed.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance: Not applicable. The approval is based on substantial equivalence to existing devices, not a standalone performance study as described for AI algorithms.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
- How ground truth for the training set was established: Not applicable.
The document is a regulatory approval letter, not a device performance study report.
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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
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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
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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 deviceintended for medical purposes that is worn on theexaminer's hand or finger to prevent contaminationbetween 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 UsePer 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 :
§ 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.