(49 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 is for a 510(k) summary for Disposable Powder Free Vinyl Exam Gloves. This type of device does not typically undergo studies with the kind of acceptance criteria, test sets, expert ground truth, MRMC studies, or standalone performance assessments that are relevant to AI/ML medical devices or complex diagnostic tools.
The "studies" described in this document are primarily non-clinical tests to ensure the physical properties and safety of the gloves meet established standards for medical devices.
Therefore, many of the requested categories (2-6, 8-9) are not applicable to this submission as they pertain to clinical or diagnostic performance, which is not evaluated for examination gloves in this manner.
Here's an interpretation based on the available information:
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Vinyl Examination Glove, Powder Free
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criterion | Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|---|
| Physical and Dimensions Testing | ASTM D5250-06 | Meets requirements (Section 7) |
| Watertight Test (Pinhole integrity) | FDA 1000 ml based on ASTM D-5151-06 (AQL 2.5, Inspection level I) | Meets requirements (Section 7) |
| Primary Skin Irritation | Acceptable biocompatibility | No primary skin irritant reactions (Section 7) |
| Skin Sensitization (Allergic Contact Dermatitis) | Acceptable biocompatibility | No sensitization reactions (Section 7) |
| Residual Powder | ASTM D6124-06 (no more than 2 mg powder per glove) | Meets "powder-free" claims (Section 7) |
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 number of samples is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) for the given batch size. Provenance is not specified, but the testing was done for the manufacturer (Xuzhou Full Sun Medical Products Ltd.) in China. This is retrospective testing of manufactured batches.
- Watertight Test: AQL 2.5, Inspection level I. The exact number of samples is not explicitly stated. Provenance is not specified, but the testing was done for the manufacturer. This is retrospective testing.
- Primary Skin Irritation and Skin Sensitization: Sample sizes for these biocompatibility tests are not disclosed but would follow standard biological test protocols. Provenance or specific subjects are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. For physical and biocompatibility testing of medical gloves, ground truth is established by standardized test methods and laboratory analysis, not by human expert consensus or interpretation in the way it is for diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This concept is not applicable to the non-clinical testing of examination gloves. Test results are objective measurements against a standard.
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
N/A. This device is an examination glove; it does not involve AI, human readers, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is an examination glove; it is not an algorithm and does not have standalone performance in the context of AI.
7. The type of ground truth used
For physical and dimensions testing, watertight testing, and residual powder testing, the "ground truth" is defined by the numerical specifications and limits set by the applicable ASTM and FDA standards (e.g., ASTM D5250-06, ASTM D-5151-06, ASTM D6124-06). For primary skin irritation and skin sensitization, the "ground truth" is established by biocompatibility test guidelines that determine the absence of adverse biological reactions.
8. The sample size for the training set
N/A. This device does not involve a "training set" in the context of machine learning or complex model development. The manufacturing process of gloves is subject to quality control, but not a "training set" in this sense.
9. How the ground truth for the training set was established
N/A. See point 8.
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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:
007 1 5 2007
Hsun-Hui Huang Xuzhou Full Sun Medical Products Ltd. Bihe Industry Area, Yitang Town Pizhou County, Jiangsu Province China
Date Summary Prepared: August 20, 2007
2. Name of the Device:
Xuzhou Full Sun Medical Products Ltd. Disposable Vinyl Examination Glove, Powder Free
3. Predicate Device Information:
Synmertex Company Limited Disposable Powder Free Vinyl Exam Glove (K032172)
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, Powder Free is substantially equivalent to the device manufactured by Synmertex Company Limited(K032172) .
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.
A residual Powder test that based on ASTM D6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims · (contain no more than 2 mg powder per gloves)
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, Powder Free 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 8 8 33
Ms. Hsun-Hui Huang Manager Xuzhou Full Sun Medical Products Limited Bihe Industry Area Yitang Town, Pizhou County Jiangsu, CHINA
Re: K072401
Trade/Device Name: Disposable Powder Free Vinyl Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 20, 2007 Received: August 27, 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 (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 (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 yours,
Clive
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
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. Applicant:
Korz 401 510(k) Number (if known): APPLIED
Device Name: Disposable Powder Free Vinyl Exam Glove
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 X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072401
§ 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.