(153 days)
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No
The document describes a standard patient examination glove and does not mention any AI or ML capabilities.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat a medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical patient examination glove, not a software application. The description focuses on material properties and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier device for infection control.
- Device Description: It is classified by the FDA as Class I under the General and Plastic Surgery Device panel (21 CFR 880.6250). IVDs are typically classified under different panels and regulations related to clinical chemistry, microbiology, hematology, etc.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on the analysis of specimens.
- Reagents, calibrators, or controls.
- Performing tests in a laboratory setting.
The device's function is purely as a physical barrier for protection, which is not the purpose 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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Product codes
LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
hand of healthcare and similar personnel
Indicated Patient Age Range
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Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows: The standards used for Shijiazhuang Great Vision Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. The FDA 1000 ml. Water Fill Test 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. A Residual Powder Test that based on ASTM D6124-01 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 glove).
Key Metrics
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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: _ Ko31108
1. Submitter's Identification:
Mr. Guixi Liu Shijiazhuang Great Vision Plastics Products Co., Ltd. Cangshi S. Road, East Dist. Jinzhou City, Hebei Province P.R. China
Date Summary Prepared: March 31, 2003
2. Name of the Device:
Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves (K000071)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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6. Comparison to Predicate Devices:
Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free, is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Shijiazhuang Great Vision Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test 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 D6124-01 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 glove).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Shijiazhuang Great Vision Plastics Co., Ltd. Synthetic (White) Vinyl Patient Examination gloves—Powder Free conform fully to ASTM-D-5250-00 standard as well as applicable 21 CFR 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 seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with three lines representing its body.
SEP - 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Great Vision Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco Incorporated 590 W. Central Avenue # D Brea, California 92821
Re: K031108
Trade/Device Name: Synthetic (White) Vinyl Patient Examination Glove-Powder Free Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 22, 2003 Received: July 23, 2003
Dear Mr. Chu:
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 vour 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 - Mr. Chu
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Patrice Cincerityffe
Susan Runner, DDS, MA Interim 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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Attachment A
Page 1 of 1
18031108 (IF KNOWN) : 510(k) NUMBER Shijiazhuang Great Vision Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic (White) Vinyl Patient Examination Gloves-Powder Free
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Clair Zidin
(Division Sign-Off) Division of Anesthesiology, Gener Infection Control, De
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
510(k) Number:
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)