(12 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
This FDA 510(k) clearance letter pertains to Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color. As such, the "device" is essentially a commodity, and the provided document is a regulatory approval, not a scientific study report. Therefore, most of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment is not present or applicable in this context.
However, I can extract information related to the device description and the regulatory context.
- Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color
- Regulation Number: 880.6250
- Regulation Name: Patient Examination Gloves
- Regulatory Class: I
- Product Code: LYZ
Since this is a clearance for examination gloves, the "acceptance criteria" generally refer to meeting established performance standards for medical gloves, which are typically defined by organizations like ASTM International. The study to prove these criteria would involve standardized physical and chemical testing. The document does not detail these specific tests or their results.
Here's how I can address the prompts based on the available information, with explanations for what cannot be found:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category (Implied for Examination Gloves) | Reported Device Performance (Information Not Present in the document) |
|---|---|
| Physical Properties | N/A |
| Biocompatibility | N/A |
| Sterility (if sterile) | N/A |
| Powder Content (if powder-free) | N/A |
| Viral Barrier | N/A |
Explanation: The letter does not describe specific acceptance criteria or performance data. For examination gloves, these criteria would typically include tests for tensile strength, elongation, barrier integrity (e.g., freedom from holes), biocompatibility (e.g., skin irritation, sensitization), and powder content as per relevant ASTM standards (e.g., ASTM D5250 for vinyl examination gloves). The "reported device performance" would be the results of these tests, which are not detailed in this regulatory letter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information Not Present: The document does not specify sample sizes for testing or data provenance.
Likely Context: For medical gloves, sample sizes for performance tests are generally determined by international standards (e.g., ISO 2859-1 for sampling procedures) or specific test methods. The data would originate from laboratory testing of glove batches, likely conducted by the manufacturer (Shanghai PM Plastics Enterprise Company Limited) in China, as that is the company's location. These would be prospective tests on manufactured samples.
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)
Information Not Applicable/Present: For a commodity device like examination gloves, "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on a diagnosis) is not applicable. The "ground truth" for glove performance is established by standardized, objective laboratory tests. The "experts" involved would be technicians performing these tests and engineers/quality control personnel interpreting the results against established standards. Their qualifications would be in laboratory testing, material science, or quality assurance, not clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information Not Applicable/Present: Adjudication methods like 2+1 or 3+1 are typically used in clinical or imaging studies where subjective interpretation is involved. For standardized physical testing of examination gloves, adjudication in this sense is not employed. Test results are objective measurements (e.g., force to break, number of pinholes) and are compared directly to numerical specifications. Quality control processes would involve reviewing test reports and ensuring compliance with specifications.
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
Information Not Applicable: This is an approval for a physical medical device (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is entirely irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information Not Applicable: As noted above, this is not an AI-powered device. Therefore, no standalone algorithm performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Type of Ground Truth: The "ground truth" for examination gloves is based on objective, standardized laboratory measurements of physical properties (e.g., tensile strength, elongation, barrier integrity) and chemical characteristics (e.g., powder content, biocompatibility) as defined by applicable consensus standards (e.g., ASTM standards for medical gloves). It is not expert consensus on an image, pathology, or outcomes data.
8. The sample size for the training set
Information Not Applicable/Present: For a physical medical device like examination gloves, there isn't a "training set" in the context of machine learning. The manufacturing process is controlled by Good Manufacturing Practices (GMPs) and quality systems, where process parameter adjustments are made based on ongoing quality control feedback and engineering principles, not a distinct "training set" of data for an algorithm.
9. How the ground truth for the training set was established
Information Not Applicable: As there is no "training set" in the machine learning sense, the concept of establishing ground truth for it is not applicable. The "ground truth" for the performance of examination gloves is established by adherence to specified performance dimensions in recognized standards, which are met through controlled manufacturing and quality assurance testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chang Te Sun Manager Shanghai PM Plastics Enterprise Company Limited No. 258, Yushu Road, Cangqiao Township, Songjiang County, Shanghai, CHINA, P.R.C.
Re: K024026
Trade/Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 15, 2002 Received: December 6, 2002
Dear Mr. Sun:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements . of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if 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) 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runrer
Timothy A. Ulatowski 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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement
INDICATIONS FOR USE
| Applicant: | SHANGHAI PM PLASTICS ENTERPRISE CO., LTD. |
|---|---|
| 510(k) Number (if known): | K02 4026 |
| Device Name: | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMGLOVES WITH ALOE VERA, GREEN COLOR |
Indications For Use:
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Qlin S. Lim
(Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devic
510(k) Number: K024026
- For a new submission, do NOT fill in the 510(k) number.
§ 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.