(117 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.
This is a 510(k) summary for a medical device that is a disposable powder-free vinyl synthetic examination glove. The document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. It is not a study of an AI-powered diagnostic device, thus many of the requested categories are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Performance / Result |
|---|---|
| Physical and Dimensions Testing | Meets requirements for Physical and Dimensions Testing based on ASTM D5250-06. (Inspection level S-2, AQL 4.0) |
| Watertight Test (Pinhole) | Meets requirements based on ASTM D-5151-06. (Samplings of AQL 2.5, Inspection level I). Also stated as "meets pinhole FDA requirements". |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Residual Powder (for "powder-free" claim) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) based on ASTM D6124-06 for Starch at finished inspection. |
| Biocompatibility | Meets biocompatibility requirements (demonstrated by Primary Skin Irritation and Skin Sensitization testing). |
| ASTM D5250-06 Compliance | Conforms fully to ASTM D-5250-06 standard. |
| Applicable 21CFR References | Conforms fully to applicable 21CFR references. |
| Labeling Claims | Meets labeling claims (as shown by data in Section 7 - which presumably refers to the "powder-free" claim and the absence of a hypoallergenic claim, as well as the 1.00 ppm lead content disclosure). Note: No special labeling claims were made, and no hypoallergenic claim was made. |
| Lead Content Disclosure | The pigment contained in the manufacture of these gloves may contain 1.00 ppm of lead (This is a disclosure, not a performance metric to meet an acceptance criterion, but it is part of the overall compliance). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Sizes:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of units sampled is not explicitly stated but is determined by the AQL and inspection level.
- Watertight Test: Samplings of AQL 2.5, Inspection level I. The exact number of units sampled is not explicitly stated.
- Primary Skin Irritation and Skin Sensitization: The document does not specify the number of subjects or samples used for these biological tests.
- Residual Powder Test: Conducted at "finished inspection," but the sample size is not specified by AQL or number of units.
- Data Provenance: The report describes non-clinical laboratory testing performed by the manufacturer. The location of the manufacturer is Xuzhou, Jiangsu Province, China. The data would therefore be considered prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the testing of a physical medical device (gloves), not an AI diagnostic algorithm. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy is not applicable here. The "ground truth" for these tests are the objective measurements against established ASTM standards and FDA requirements.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. The tests performed are objective, quantitative 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 document pertains to physical product testing of medical gloves, not an AI-powered diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on established industry standards (ASTM) and FDA regulatory requirements. These are objective measurements and biological test results, not expert consensus, pathology, or outcomes data in the diagnostic sense. For example, a glove either passes the watertight test according to the AQL, or it doesn't.
8. The Sample Size for the Training Set
Not applicable. This is not an AI-powered device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI-powered device.
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REVISED 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(K) safety and effectiveness information is being submitted in Accordance with requirements of SMDA 1990 and 21 CFR 807.92.
DEC 1 2 2007
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 Revised: Dec. 10, 2007
2. Name of the Device:
Xuzhou Full Sun Medical Products Ltd. Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color
3. Predicate Device Information:
Canopus Medical Supply Company Limited. Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color (K023728)
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 Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color is substantially equivalent to the device manufactured by Canopus Medical Supply Company Limited. (K023728).
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, AOL 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.
Conclusions: 9.
Xuzhou Full Sun Medical Products Ltd's Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green 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.
The pigment contained in the manufacture of these gloves may contain 1.00 ppm of lead.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three stripes on its wings.
DEC 1 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hsun-Hui Huang Manager Xuzhou Full Sun Medical Products, Ltd. Bihe Industry Area, Yitang Town Pizhou County, Jiangsu Province CHINA
Re: K072314
Trade/Device Name: Disposable Powder Free Vinyl Synthetic Exam Gloves, With Aloe Vera, Green Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 19, 2007 Received: November 23, 2007
Dear Mr. 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, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. 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,
Clus
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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Applicant: XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
510(k) Number (if known): APPLIED
Device Name: Disposable Powder Free Vinyl Synthetic Exam Gloves, With
Aloe Vera, Green 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.
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
| 510(k) Number: | K072314 |
|---|---|
| Prescription Use(Part 21 CFR 801 Subpart D) | Over-The-Counter Use XAND/OR(21 CFR 801 Subpart C) |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.