(98 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.
Here's the breakdown of the acceptance criteria and study information based on the provided text, focused on the aspects typically used to describe medical device performance studies:
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Powder Free Vinyl Exam Glove Yellow Color
This 510(k) summary primarily addresses the substantial equivalence of a disposable medical glove to a predicate device, focusing on material and physical integrity rather than a complex AI or diagnostic performance study. As such, the typical metrics for diagnostic device performance (e.g., sensitivity, specificity, AUC) are not applicable. Instead, the acceptance criteria relate to compliance with established ASTM standards and FDA requirements for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Performance Metric | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing (ASTM D5250-06) | Meets requirements for physical properties and dimensions. | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0." |
| Watertight Test (ASTM D-5151-06) | Watertight integrity (Pinhole detection). | "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 | Absence of primary skin irritant reactions. | "Primary Skin irritation... testing was conducted with results showing no primary skin irritant... reactions." |
| Skin Sensitization (allergic contact dermatitis) | Absence of sensitization reactions. | "Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no... sensitization reactions." |
| Residual Powder Test (ASTM D6124-06 for starch) | Powder content for "powder-free" claim (≤ 2 mg/glove). | "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)." |
| Biocompatibility | Satisfies biocompatibility requirements. | "meets... biocompatibility requirements" (implied by skin irritation/sensitization tests and general compliance). |
| Labeling Claims | Consistency with regulatory guidelines. | "meets... labeling claims" |
2. Sample Size Used for the Test Set and Data Provenance
The document provides specific sample sizes and inspection levels for certain tests:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Exact numerical sample size not specified, but refers to a standard sampling plan).
- Watertight Test: AQL 2.5, Inspection level I. (Exact numerical sample size not specified, but refers to a standard sampling plan).
- Skin irritation and Sensitization testing: Sample size not specified.
- Residual Powder Test: Sample size not specified.
The data provenance is the manufacturer, Xuzhou Full Sun Medical Products Ltd., in Jiangsu Province, China. The studies are prospective in the sense that they are performed on the manufactured product to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a Class I medical device (patient examination glove), and the compliance is assessed through standardized physical, chemical, and biological tests, not through expert interpretation of medical images or diagnostic data. Therefore, "ground truth" as typically defined for AI or diagnostic devices is not established by a panel of experts. The standards themselves define the "ground truth" for acceptable performance.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements or established biological assays, not subjective assessments requiring adjudication.
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 not a diagnostic device or an AI-powered system that involves human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The tests performed are standalone in the sense that they assess the device's inherent properties.
7. The Type of Ground Truth Used
The "ground truth" is defined by adherence to accepted industry standards and regulatory requirements. This includes:
- ASTM Standard D5250-06: For physical and dimensional properties of vinyl examination gloves.
- ASTM Standard D-5151-06: For pinhole detection in medical gloves (watertight test).
- ASTM Standard D6124-06: For residual powder content.
- Biocompatibility principles: Demonstrated through skin irritation and sensitization tests.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, this question is not relevant.
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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:
Hsun-Hui Huang Xuzhou Full Sun Medical Products Ltd. Bihe Industry Area, yitang Town Pizhou County, Jiangsu Province China
Date Summary Prepared: March 26, 2007
2. Name of the Device:
Xuzhou Full Sun Medical Products Ltd. Disposable Powder Free Vinyl Exam Glove Yellow Color
3. Predicate Device Information:
Safehealth Medical Supply Corp Vinyl Examination Glove,Powder Free (K955091)
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.
JUL 30 2007
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6.Comparison to Predicate Devices:
Xuzhou Full Sun Medical Products Ltd's Disposable Powder Free Vinyl Exam Glove, Yellow Color is substantially equivalent to the device manufactured by Safehealth Medical Supply Corp. (K955091) except for the yellow color additive being added to this glove.
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 Powder Free Vinyl Exam Glove, Yellow Color 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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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2007
Ms. Elizabeth Deng Xuzhou Full Sun Medical Products, Limited 9650 Milliken Avenue, #5218 Rancho Cucamonga, California 91730
Re: K071123
Trade/Device Name: Disposable Powder Free Vinyl Exam Glove Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 9, 2007 Received: July 17, 2007
Dear Ms. Deng:
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. Deng
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Suttie Y. Michael M.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
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. Applicant:
K071123 510(k) Number (if known): APPLIED
Device Name: Disposable Powder Free Vinyl Exam Glove Yellow Color
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)
Shula A. Murphy
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Provinces Destablogy, General Reviens Division Control, Dental Devices
510(k) Number: K071123
§ 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.