(233 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, Powdered Vinyl Patient Examination Glove, 801.VZ, and meets all requirements of ASTM Standard D5250-06
Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Powdered Vinyl Exam Glove, Yellow Color:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D5250-06, FDA 1000 ml Watertight Test, Biocompatibility testing) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Meets requirements as per ASTM D5250-06. (Inspection level S-2, AQL 4.0) | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0." |
| Watertight Test (Pinhole): Meets requirements as per FDA 1000 ml Watertight Test based on ASTM D-5151-06. (Sampling AQL 2.5, Inspection level I) | "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: No primary skin irritant reactions. | "Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant..." |
| Skin Sensitization (Allergic Contact Dermatitis): No sensitization reactions. | "...or sensitization reactions." |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing:
- Sample Size: Not explicitly stated as a numerical value for each test. Instead, it refers to an "Inspection level S-2, AQL 4.0" which dictates the sampling plan based on the lot size.
- Data Provenance: Not explicitly stated for these tests, but the manufacturer is in China. The testing was likely conducted by the manufacturer or a contracted lab. It is retrospective, as the data is presented for a device already manufactured.
- Watertight Test (Pinhole):
- Sample Size: Not explicitly stated as a numerical value for each test. It refers to "samplings of AQL 2.5, Inspection level I" which dictates the sampling plan based on the lot size.
- Data Provenance: Not explicitly stated, but likely the same as above (retrospective, probably China-based testing facility).
- Primary Skin Irritation and Skin Sensitization:
- Sample Size: Not specified for these biological tests.
- Data Provenance: Not specified, but likely proprietary testing conducted by or for the manufacturer. It is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and its testing. The "ground truth" for a medical glove is established through objective physical and chemical testing against established standards (ASTM standards, FDA watertight tests) and biocompatibility studies. It does not involve human expert interpretation or diagnosis for establishing a "ground truth" like in imaging or diagnostic AI.
4. Adjudication Method for the Test Set
This is not applicable. The nature of the testing (physical properties, watertight integrity, biocompatibility) does not require an adjudication method as would be used for subjective assessments or expert consensus in, for example, medical imaging studies. The results are objective measurements or categorical observations (e.g., irritation present/absent).
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
This is not applicable. The device is a patient examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the impact of AI on human reader performance, which doesn't apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This device is a physical medical product (a glove), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Objective Measurement against ASTM Standards: For physical properties and dimensions (e.g., tensile strength, elongation, dimensions).
- Objective Test Results: For watertight integrity (pinhole test).
- Biocompatibility Testing Results: For primary skin irritation and sensitization, following established test protocols for biological evaluation of medical devices.
8. The Sample Size for the Training Set
This is not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. Since there is no training set, there is no ground truth to be established for it.
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DEC 1 2 2007
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.
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
Date Summary Revised: Dec. 10, 2007
2. Name of the Device:
Xuzhou full Sun Medical Products Ltd. Disposable Powdered Vinyl Exam Glove Yellow Color
3. Predicate Device Information:
Assured Medical Supply Company, Ltd. Vinyl Examination Glove (K932054)
4. Device description:
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 801.VZ, 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 Powdered Vinyl Exam Glove, Yellow Color is substantially equivalent to the device mamufactured by Assured Medical Supply Company, Ltd. (K932054) 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.
8. Discussion of Clinic Tests Performed:
Not applicable - There is no Hypoallergenic Claim.
9. Conclusions:
Xuzhou full Sun Medical Products Ltd.' s Disposable Powdered 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,
The pigment contained in the manufacture of these gloves may contain 1.00 ppm of lead.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular pattern.
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
Rc: K071122
Trade/Device Name: Disposable Powdered Vinyl Exam Gloves, Yellow 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 (IPMA), 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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Pagc 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.
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:
510(k) Number (if known): APPLIED
Device Name: Disposable Powdered 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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
oncurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K071122
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§ 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.