(48 days)
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Poly-Isoprene Non-Latex Sterile Powder-Free Surgeon's Glove, organized according to your requested points:
The provided text is a 510(k) clearance letter from the FDA for a surgeon's glove and its Indications for Use statement. It does not contain detailed information about acceptance criteria or specific study results showing the device meets those criteria.
A 510(k) clearance relies on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparing device characteristics (including performance) to the predicate device and showing that differences don't raise new questions of safety or effectiveness. While performance tests are conducted, the detailed acceptance criteria and study results are usually part of the 510(k) submission materials and not fully presented in the FDA's clearance letter itself.
Therefore, for almost all your requested points, the answer based solely on the provided text will be that the information is not available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The FDA clearance letter confirms "substantial equivalence" to a predicate device, implying that performance met the standards of the predicate, but the specific numerical criteria or performance results are not detailed here. | Not specified in this document. The FDA clearance letter only states that the device is "substantially equivalent" for its intended use. |
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 used for the test set: Not specified in this document.
- Data provenance: Not specified 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)
- Not applicable to this type of device and document. For a surgeon's glove, "ground truth" as typically understood in medical device studies (e.g., for AI algorithms or diagnostic tools) involving expert review wouldn't be relevant. Performance is generally assessed via standardized physical and chemical tests (e.g., tensile strength, puncture resistance, sterility, barrier integrity). The FDA reviewer (Chiu Lin, Ph.D., Director of Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) assessed the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to this type of device and document. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth from expert opinions in diagnostic or interpretive tasks, which is not relevant for a surgeon's glove performance evaluation.
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
- No, this is not applicable. MRMC studies and the concept of "human readers" improving with AI assistance are relevant for AI-powered diagnostic or assistive devices, not for a surgeon's glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This applies to AI algorithms, not a surgeon's glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a surgeon's glove, the "ground truth" for performance would be based on objective measurements from standardized tests (e.g., ASTM standards for glove performance such as tensile strength, elongation, puncture resistance, barrier integrity (water leak test), and sterility testing) compared against predetermined specifications. It is not established by expert consensus or pathology in the same way a diagnostic device would be.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm. If "training set" refers to manufacturing process validation or quality control, that information is not provided in this regulatory letter.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI algorithm.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features an abstract design of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 16 2005
Ms. Kathleen Harris Global Regulatory Manager Regent Medical Americas, LLC 3585 Engineering Drive, Suite 250 Norcross, Georgia 30092
Re: K050184
KU50184
Trade/Device Name: Poly-Isoprene Non-Latex Sterile Powder-Free Surgeon's Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 14, 2005 Received: March 9, 2005
Dear Ms. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becally of the device is substantially equivalent (for the referenced above and have decemined and to headly marketed predicate devices marketed in indications for use stated in the encreases, 1976, the enactment date of the Medical Device interstate conmittee prior to may 20, 177, as a secondance with the provisions of Affiellents, or to devrees mat have over (Act) that do not require approval of a premarket the Federal Food, Drug, and Ocometto 100 (refere, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the Fiel. "The girling of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (See above) into controls. Existing major regulations affecting (PMA), it may be subject to Sach addin Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sode 77 received.
addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Harris
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S issualled on a subscurity with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA nas made a decemination that your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations and mot limited to: registration of the Act or any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements and manufacturing prectice You must comply with an the Act 3 requirements integral manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 820); and i and listing (21 CPK Part 807), laboling (21 CFR Parvalson (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to begin matically your as ial equivalence of your device to a premarket notification. THCTDA mixing of basication 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), If you desire specific advice for your at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other other general meetirs, International and Consumer Assistance at its toll-free Division of 0.638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chin Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050184
Device Name: Poly-Isoprene non-latex sterile powder-free surgeon's glove
Indications For Use:
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).