(51 days)
A PATIENT EXAMINATION GLOVES 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.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06
The provided text describes a 510(k) submission for "Disposable Vinyl Examination Glove, Powdered" and does not contain information about a study proving a device meets acceptance criteria using AI or machine learning. The submission is for a medical glove, which is a physical product, not a software or AI-based device.
Therefore, the requested information fields related to AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
However, I can extract the acceptance criteria and performance related to the physical glove as described in the 510(k) summary.
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd.'s Disposable Vinyl Examination Glove, Powdered
The device is a physical product (medical glove), and its acceptance criteria and performance are based on established ASTM standards and FDA requirements for such devices. The document does not describe AI/ML performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Performance Metric | Reported Device Performance |
|---|---|---|
| ASTM D5250-06 | Physical and Dimensions Testing | Meets all requirements, Inspection level S-2, AQL 4.0 |
| FDA 1000 ml Watertight Test (based on ASTM D-5151-06) | Pinhole Rate | Meets requirements, AQL 2.5, Inspection level I |
| Biocompatibility (Primary Skin Irritation) | Skin Irritation | No primary skin irritant reactions |
| Biocompatibility (Skin Sensitization) | Skin Sensitization | No sensitization reactions (allergic contact dermatitis) |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact sample size (number of gloves tested) is not specified but is implied by the AQL (Acceptance Quality Limit) and inspection level, which are standard statistical sampling plans.
- FDA 1000 ml Watertight Test: AQL 2.5, Inspection level I. The exact sample size is not specified but is implied by the AQL and inspection level.
- Biocompatibility Testing: The number of subjects or samples used for primary skin irritation and sensitization testing is not specified in this summary.
- Data Provenance: The tests were performed by the manufacturer, Xuzhou Full Sun Medical Products Ltd. (China). The data is presented retrospectively as part of the 510(k) submission for marketing clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for a medical glove involves physical properties and biological reactions, which are determined by standardized laboratory tests and assessments, not expert consensus on interpretations like with AI/imaging.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of interpretations. Test results are objective measurements against predefined standards.
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
Not applicable. This is a physical product (glove), not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used
- Physical and Dimensions: The truth is defined by the specifications and tolerances outlined in ASTM D5250-06.
- Pinhole Detection: The truth is defined by the absence of leaks as per the FDA 1000 ml Watertight Test based on ASTM D-5151-06.
- Biocompatibility: The truth is defined by the absence of observable adverse reactions (irritation, sensitization) in standard biological tests.
8. The sample size for the training set
Not applicable. This is a manufactured product, referring to "training set" doesn't apply in the context of AI/ML. Manufacturing processes are "trained" through quality control and process adjustments, but not in the AI sense.
9. How the ground truth for the training set was established
Not applicable. Again, this refers to AI/ML context, which is not relevant here. Manufacturing quality is maintained through adherence to Good Manufacturing Practices (GMP) and ongoing quality control, referencing the same ASTM standards.
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510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in Accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(K) number is:
1. Submitter's Identification:
Ms. Hsun-Hui Huang Xuzhou full Sun Medical Products Ltd. Bihe industry Area, Yitang Town Pizhou County, Jiangsu Province China
007 25 2007
Date Summary Prepared: Aug. 10, 2007
2. Name of the Device:
Xuzhou full Sun Medical Products Ltd. Disposable Vinyl Examination Glove, Powdered
3. Predicate Device Information:
Synmertex Co., Ltd. Disposable Powdered Vinyl Exam Gloves (K032190)
4. Device description:
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06
5. Intended 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.
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6.Comparison to Predicate Devices:
Xuzhou full Sun Medical Products Ltd.'s Disposable Vinyl Examination Glove. Powdered is substantially equivalent to the device manufactured by Synmertex Co., Ltd. (K032190).
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Xuzhou full Sun Medical Products Ltd.'s glove production are Based on ASTM D5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0,
The FDA 1000 ml Watertight Test based on ASTM D-5151-06 was also conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
8. Discussion of Clinic Tests Performed:
Not applicable - There is no Hypoallergenic Claim.
9. Conclusions:
Xuzhou full Sun Medical Products Ltd.' s Disposable Vinyl Examination Glove, Powdered conform fully to ASTM D-5250-06 standard as well as applicable 21CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized abstract symbol to the right, consisting of three curved lines that resemble human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2007
Ms. Hsun-Hui Huang Manager Xuzhou Full Sun Medical Products Limited Bihe Industry Area Yitang Town, Pizhou County Jiangsu, CHINA
Re: K072472
Trade/Device Name: Disposable Vinyl Examination Gloves, Powdered Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 17, 2007 Received: October 22, 2007
Dear Ms, Huang:
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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Page 2 - Ms. Huang
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 (OS) 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 (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 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/industry/support/index.html.
Sincerely vours.
Chiu 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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XUZHOU FULL SUN MEDICAL PRODUCTS LTD. Applicant:
510(k) Number (if known): APPLIED
Device Name: Disposable Vinyl Examination Glove, Powdered
Indications for Use:
A PATIENT EXAMINATION GLOVES 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office, of Device Evaluation (ODE)
Marin Company of Comments of Children Computers and Charlesses and Charles and Children College Markets
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 0 17472
§ 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.