(88 days)
A 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. For Medical Use
Uni-Gloves Brand Patient Examination Glove (Powder-Free)
Here is the information you requested based on the provided document:
This document is a 510(k) clearance letter from the FDA for a medical device (Unigloves Powder Free Latex Examination Gloves). This type of document typically does not contain detailed studies on acceptance criteria or device performance data, as it's a clearance for substantial equivalence to a predicate device, not a new device approval requiring extensive clinical trial results. Therefore, many of your requested items cannot be definitively answered from this letter.
However, I can extract the information that is present and indicate where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in this document. The letter refers to "substantial equivalence" to predicate devices, implying performance meets baseline medical device standards. | Not explicitly stated in this document. The letter does not include performance data or studies. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not available in this document.
- Data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not available in this document.
- Qualifications of experts: Not available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device is a physical medical device (examination gloves), not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a physical medical device (examination gloves), not an algorithm or software. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in this document. For devices like examination gloves, "ground truth" often relates to material properties (e.g., tensile strength, barrier integrity) and biocompatibility, which would be tested against established standards rather than clinical "ground truth" like pathology.
8. The sample size for the training set
- Not applicable/Not available. This document pertains to a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.
9. How the ground truth for the training set was established
- Not applicable/Not available. As above, there is no "training set" for this type of device.
Summary of what the document does provide:
- Device Name: Unigloves Powder Free Latex Examination Gloves
- Regulatory Class: I
- Product Code: LYY
- Indications For Use: "A 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."
- Regulatory Status: Substantially Equivalent (K971731) to predicate devices marketed prior to May 28, 1976.
- Use Type: Over-The-Counter Use X (as specified in the enclosure)
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "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 stylized human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert D. Vander Leek President
AUG - 5 1997
r Uni-Glove USA, Incorporated ----------2420 Carson Street, Suite 125 Torrance, California 90501
Re : K971731 Trade Name: Unigloves Powder Free Latex Examination Gloves Regulatory Class: I Product Code: LYY Dated: June 23, 1997 Received: June 27, 1997
Dear Mr. Vander Leek:
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 of the Act. The general controls provisions 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. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical
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Page 2 - Mr. Lim
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 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 diaqnostic 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.qov/cdrh/dsmamain.html".
Sincerely yours,
L. Alatoush'
Timoty A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT G
K971731 510(k) Number (if known): Uni-Gloves Brand Device Name:__Patient_Examination_Glove (Powder-Free).
Indications For Use:
A 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.
For Medical Use
(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 Dentsi, infection Control,
and General Hospital Devices
510(k) Number K971731
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 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.