(49 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare similar personnel to prevent contamination between and healthcare personnel and the patient's body, fluids, waste or environment.
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.
Classified by FDA's General and Plastic Surgery Device Panel 21 CFR 880.6250, Powdered Vinyl Patient Class I, as Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
The provided text is for a 510(k) summary for medical gloves, which are low-risk devices and do not typically involve the types of studies and acceptance criteria that are relevant to AI/ML-powered medical devices. Therefore, much of the requested information, such as multi-reader multi-case studies, standalone algorithm performance, and expert ground truth establishment, is not applicable.
Here's the information that can be extracted or deduced from the provided document, formatted to best fit the request for an AI/ML device, with explanations where the information is not directly applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Shijiazhuang Great Eagle Plastic Products Co., Ltd. glove production standards 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. |
| Pinhole Detection (Water Fill Test): | The FDA 1000 ml. Water Fill Test was conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. |
| Biocompatibility (Primary Skin Irritation): | Primary Skin Irritation testing was conducted with results showing no primary skin irritant reactions. |
| Biocompatibility (Skin Sensitization): | Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no sensitization reactions. |
| Overall Conformance to Standards: | Conform fully to ASTM-D-5250-92 standards as well as applicable CFR 21 pinhole references, and meets 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. Sample Size Used for the Test Set and Data Provenance
The document specifies "samplings of AQL 2.5, Inspection Level S-4" for the Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing. These are statistical sampling plans from ASTM standards, not a fixed sample size in the context of typical AI/ML test sets. The exact number of gloves tested for each lot would depend on the size of the manufacturing lot.
Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in China. The data is from non-clinical testing performed by the manufacturer to demonstrate compliance with standards. It is implicitly retrospective in the sense that the tests were performed on manufactured batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for medical gloves is established by objective physical and chemical tests (e.g., water leak tests, measurements of dimensions, chemical assays for irritation). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of images or data to establish ground truth in diagnostic studies. For glove testing, the results are typically quantitative measurements or pass/fail criteria against established standards.
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
Not applicable. This device is a medical glove, not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective measurement against established industry and regulatory standards. Specifically:
- Physical and Dimensional Characteristics: Defined by ASTM-D-5250-92.
- Barrier Integrity (Pinhole): Defined by FDA 1000 ml. Water Fill Test (referencing CFR 21 pinhole references) and ASTM-D-5250-92.
- Biocompatibility: Established through Primary Skin Irritation and Skin Sensitization testing, performed to determine the absence of adverse biological reactions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML model that requires a training set. The "training" for glove manufacturing would involve process control and quality assurance to meet the specified standards across all production.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI/ML training set, there is no ground truth to be established in this context. The "ground truth" equivalent for manufacturing is the adherence to the ASTM-D-5250-92 standard and internal quality specifications during the production process.
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DEC 4 1998
EXHIBIT #1 Page 1 of 2
510 (K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: 983645
1. Submitter's Identification:
Mr. Fanq Yi Liu Shijiazhuang Great Eagle Plastic Products Co., Ltd. 685 He Ping Road New Development Zone Shijiazhuang, He Bei Province P.R. China
Date Summary Prepared: October 14, 1998
2. Name of the Device:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves
3. Predicate Device Information:
Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves, K#960746 Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves, K#974151
4 . Device Description:
Classified by FDA's General and Plastic Surgery Device Panel 21 CFR 880.6250, Powdered Vinyl Patient Class I, as Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III 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 similar personnel to prevent contamination between and healthcare personnel and the patient's body, fluids, waste or environment.
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EXHIBIT #1 Page 2 of 2
Comparison to Predicate Devices: 6.
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax In Barcey and CricoloronesBal Vinyl Patient Enterprise Examination Gloves and the Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves.
Discussion of Non-Clinical Tests Performed for Determination 7. of Substantial Equivalence are as follows:
standards used for Shijiazhuang Great Eagle Plastic The Products Co., Ltd. glove production are based on ASTM-D-5250-All testing meets requirements for Physical and 92. 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 qloves as hypoallergenic on our labels.
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves (Powdered) conform fully to ASTM-D-5250-92 standards as well as applicable CFR 21 pinhole references, and, meets -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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Shijiazhuang Great Eagle Plastics Products Company, Ltd. C/O Ms. Susan Goldstein-Falk Official Correspondent Basic Medical Industries, Incorporated 13945 Magnolia Avenue 91710 Chino, California
K983645 Re: Powdered Vinyl Patient Examination Gloves Trade Name: Requlatory Class: I Product Code: LYZ Dated: October 14, 1998 Received: October 16, 1998
Dear Ms. Goldstein-Falk:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉੱ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
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Page 2 - Ms. Goldstein-Falk
This letter will allow you to begin marketing your device as Inis icece described in your sie in promience of your device to a legally Finding of subscancedir equired in a classification for your marketed predicate awits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (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 Compliance at (501) 331 ising 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 obtained from the brying (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
thy A. Time 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
| 510(k) NUMBER (IF KNOWN): | |
|---|---|
| DEVICE NAME: | Shijiazhuang Great Eagle Plastics Products Co., Ltd.Powdered Vinyl Patient Examination Gloves-Powdere |
| INDICATIONS FOR USE: |
A patient examination glove is a disposable device intended for medical purposes that is A pation. Oxaminer'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)
-The-Counter-Use X Prescription Use (Division Sign-Off (Optional Format 1-2-96) (Per 21 CFR 801.109) Division of Dental, Infection Control and General Hospital Devi 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.