(76 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 800,6250, Powder-Free Vinvl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D5250-92 (all requirements) | Meets all requirements for Physical and Dimensions Testing, Inspection Level S-2, AQL 4.0 |
| FDA 1000 ml. Water Fill Test (pinhole defect) | Meets requirements for AQL 2.5, Inspection Level S-4 |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| USP Iodine Test for Starch (powder-free claim) | Revealed passing results |
| Applicable 21 CFR references | Conforms fully |
| Biocompatibility requirements | Meets requirements (implied by skin irritation/sensitization testing) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0 (The exact number of gloves tested is not specified but is a standard sampling plan based on lot size).
- FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5 (The exact number of gloves tested is not specified but is a standard sampling plan based on lot size).
- Primary Skin Irritation and Skin Sensitization: Not specified, but generally involves human subjects or animal models.
- USP Iodine Test: Not specified, but performed during finished inspection.
- Data Provenance: Not explicitly stated, but the submission is from a company in P.R. China, implying the testing likely occurred there or at a contract lab. The studies would be considered prospective as they were conducted specifically to demonstrate compliance for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of medical device (patient examination gloves) does not typically involve "experts" in the sense of clinicians establishing ground truth for performance, as would be the case for diagnostic imaging or AI devices. The ground truth is established by standardized testing methods and regulatory limits (e.g., maximum acceptable pinhole rate, absence of irritation).
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective, standardized laboratory and physical tests, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their performance. This device is a physical barrier protection, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical product, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance (e.g., pinhole rate, tensile strength) is inherently "standalone" in that it's measured directly from the product.
7. The Type of Ground Truth Used:
The ground truth for this device is based on established industry standards and regulatory requirements, specifically:
- ASTM Standard D5250-92: Defines physical properties, dimensions, and testing methods for vinyl patient examination gloves.
- FDA 1000 ml. Water Fill Test: A regulatory standard for assessing pinhole defects.
- Biocompatibility Standards: Implicitly covered by Primary Skin Irritation and Skin Sensitization testing, aiming for a lack of adverse biological reactions.
- USP Iodine Test for Starch: A standard method to verify "powder-free" claims.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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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: _ K99 2555
1. Submitter's Identification:
Mr. Fang Yi Liu Shijiazhuang Great Vision Plastics Products Co., Ltd. Cangshi Road (S) Jinzhou City, Hebei Province P.R. China
Date Summary Prepared: July 15, 1999
2. Name of the Device:
Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves
3. Predicate Device Information:
Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#964964 Cheer & Merit Co .. Ltd. Powder-Free Vinyl Patient Examination Gloves, K#942042
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 800,6250, Powder-Free Vinvl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
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 Powder-Free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves and the Cheer & Merit Powder-Free 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-5250-92. 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 S-4, 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 USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims. We adhere to all USP Iodine test methodogy and testing conducted revealed passing results.
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Shijiazhuang Great Vision Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves (Powder-Free) conform fully to ASTM-D-5250-92 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1999
Shijiazhuang Great Vision Plastics Products Co., Ltd. c/o Karen Abell Official Correspondent for Shijiazhuang Great Vision Plastics Products Co., Ltd. Basic Medical Industries Incorporated 13945 Magnolia Avenue Chino, CA 91710
Re: K992555 Trade Name: Synthetic Powder-Free Vinyl Patient Examination Gloves Requlatory Class: I Product Code: LYZ Dated: July 30, 1999 Received: July 30, 1999
Dear Ms. Abell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Ms. Abell
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Runner
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A
Page 1 of 1
1 age 1 of 1 - 1 - 1 - KNOWN) : 1 - 9 ( 2 5 5 5
DEVICE NAME: - - - - Shijiazhuang Great Vision Shijiazhuang Great Vision Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Powder Free Vinyl Patient Examination Gloves-Powder Free
A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrent of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | ------------------------------------------------------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter-Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number |
|---|
| --------------- |
§ 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.