(51 days)
No
The device description and performance studies focus on the physical properties and testing of examination gloves, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device, a patient examination glove, is intended for preventing contamination during examinations, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical glove, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device used during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description classifies it as a "Powder-Free Vinyl Patient Examination Glove" under 21 CFR 880.6250. This regulation specifically covers patient examination gloves, which are not IVDs.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The purpose of this device is to provide a physical barrier, which is a fundamental difference from the function of an IVD.
N/A
Intended Use / Indications for 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.
Product codes
LYZ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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2
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
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