(153 days)
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.
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document describes the 510(k) submission for Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free. As such, the "device" in this context refers to these examination gloves. The studies described are primarily non-clinical, focusing on manufacturing standards and material properties rather than clinical performance (e.g., diagnostic accuracy of an AI algorithm).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-5250-00) | Meets requirements |
| Inspection Level S-2 | Achieved |
| AQL 4.0 | Achieved |
| Pinhole Water Fill Test (FDA 1000 ml.) | Meets requirements |
| AQL 2.5 | Achieved |
| Inspection Level I | Achieved |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions |
| Residual Powder Test (ASTM D6124-01) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test performed (e.g., how many gloves were tested for pinholes, or how many subjects for skin irritation). It refers to:
- Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (These are sampling plans from quality control standards, implying a specific number of gloves would be inspected from a lot, but the exact number isn't given).
- FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I" (Similarly, a sampling plan).
- Primary Skin Irritation and Skin Sensitization: The number of subjects is not specified.
- Residual Powder Test: Not specified.
Data Provenance: Not explicitly stated, but the tests were conducted by or for the manufacturer, Shijiazhuang Great Vision Plastics Products Co., Ltd., based in Hebei Province, P.R. China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical product (gloves), not an AI/diagnostic device that relies on expert interpretation for ground truth establishment. The "ground truth" here is defined by physical and chemical properties and patient safety endpoints, measured by established testing methods.
4. Adjudication Method for the Test Set
Not applicable. Since the tests are objective measurements against predefined standards (e.g., water leak, powder content, skin reaction), there is no need for expert adjudication in the way it would be applied to subjective image interpretation or clinical diagnosis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not done. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an algorithm or AI device.
7. Type of Ground Truth Used
The "ground truth" for the performance claims of these gloves is based on:
- Standardized Physical Measurements: Adherence to ASTM-D-5250-00 for physical properties and dimensions, and ASTM D6124-01 for residual powder.
- Biocompatibility Testing: Results from primary skin irritation and sensitization tests.
- FDA Pinhole Requirements: Passing the FDA's 1000 ml Water Fill Test.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for glove manufacturing would involve process control and quality assurance, not data training in a computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set in the context of an AI device, no ground truth needs to be established for it.
{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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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)
§ 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.