(125 days)
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.
The device is powdered synthetic vinyl exam glove. They are nonsterile, single use, disposable gloves.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the Synthetic Vinyl Examination Glove, Powdered:
Acceptance Criteria and Device Performance
The documents primarily focus on demonstrating substantial equivalence to a predicate device for regulatory clearance. The "acceptance criteria" are implied by the performance standards and tests the device claims to have met or exceeded.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied Standard/Test) | Reported Device Performance |
|---|---|
| Physical Performance: | |
| ASTM D5250 (Standard Specification for Poly(vinyl chloride) Gloves for Medical Application) | Met and/or exceeded requirements |
| FDA Water Leak Test (before & after aging) | Met and/or exceeded requirements |
| Biocompatibility/Safety: | |
| Primary Skin Irritation Study | Met and/or exceeded requirements |
| Dermal Sensitization Study | Met and/or exceeded requirements |
| FDA Surgical Glove Bio-Burden Test | Met and/or exceeded requirements |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not explicitly state the sample sizes used for each of the tests (e.g., number of gloves for water leak, number of subjects for skin irritation).
The data provenance is stated as: "All tests were performed in a certified testing laboratory." No country of origin for the data is specified, but the submission is to the U.S. FDA. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission, rather than being retrospective analyses of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the performance testing of a medical device like an examination glove. The "ground truth" for these tests are the established and recognized standard testing methodologies specified by ASTM or FDA. There isn't an "expert" concensus on whether a glove leaks, but rather a pass/fail determination based on a defined protocol.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective physical and biological tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is typically for evaluating diagnostic or imaging devices where human readers interpret results. This is a simple medical device (examination glove) with clear performance metrics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not relevant to this device. This device is not an algorithm or AI. Its performance is inherent in its physical and material properties.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests (water leak, irritation, sensitization, bioburden, ASTM D5250 compliance) is based on:
- Established Standard Specifications: ASTM D5250 dictates material properties and performance requirements for the glove.
- Defined Test Protocols: FDA Water Leak, Primary Skin Irritation, Dermal Sensitization, and Surgical Glove Bio-Burden tests have specific, standardized methodologies to determine compliance.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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SEP 3 0 1998
JANNA TUCKER & ASSOCIATES
198 Avenue de la D'Emerald Sparks, NV 89434 Ph: 702-342-2612 Fax: 702-342-2613
981876
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
HSING YI PLASTICS PROCESSING CO., LTD SYNTHETIC VINYL EXAMINATION GLOVE, POWDERED
Janna P. Tucker, President, Janna Tucker & Associates
Submitter:
Janna Tucker & Associates 198 Avenue de la D'emerald Sparks, NV 89434
(702) 343-2612 PHONE: FAX: (702) 343-2613
Contact Person:
Date Prepared:
May 26, 1998 (Revised July 6, 1998)
(Multiple) Synthetic Vinyl Examination Glove Trade Name: Synthetic Vinyl Exam Glove Common Name: Classification Name: Patient Examination Glove, Class I, 80LYZ
Summary of Safety and Effectiveness:
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "... (510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the preparer.
NEW DEVICE NAME:
SYNTHETIC VINYL EXAMINATION GLOVE, POWDERED
PREDICATE DEVICE NAME: Synthetic Vinyl Exam Glove
Device Description:
The device is powdered synthetic vinyl exam glove. They are nonsterile, single use, disposable gloves.
This synthetic vinyl exam glove is intended for medical purposes Intended Use: that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
EXHIBIT I
Page 23 of 24 (Revised 7/6/98)
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| Indications Statement: | 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. |
|---|---|
| TechnologicalCharacteristics | This synthetic vinyl exam glove has the same technological characteristics as predicate devices. The device is manufactured in standard sizes. |
| Performance Data: | The device has met and/or exceeded the requirements of the following standards and laboratory tests: |
| ASTM D5250 | |
| Primary Skin Irritation Study | |
| Dermal Sensitization Study | |
| FDA Surgical Glove Bio-Burden Test | |
| FDA Water Leak, before & after aging | |
| All tests were performed in a certified testing laboratory. | |
| Conclusions: | Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the device is substantially equivalent to other like devices under the Federal Food, Drug, and Cosmetic Act. |
·
JANNA P. TUCKER, President Janna Tucker & Associates Official Correspondent for Hsing Yi Plastics Processing Co., Ltd
EXHIBIT I
Page 24 of 24 (Revised 7/6/98)
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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 features a stylized image of three human profiles facing right, layered on top of each other. The profiles are black and have a minimalist design. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Hsing Yi Plastic Processing Company, Limited C/O Ms. Janna P. Tucker President Janna Tucker & Associates 198 Avenue de la D'Emerald Sparks, Neveda 89434
Re : K981876 Trade Name: Synthetic Vinyl Examination Glove, Powdered Requlatory Class: I Product Code: LYZ Dated: September 22, 1998 Received: September 18, 1998
Dear Ms. Tucker:
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 leqally 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). 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 (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. ਰੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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
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Page 2 - Ms. Tucker
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 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" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".
Sincerely yours, ………………
Susan Biare
fe
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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INDICATIONS FOR USE
..
APPLICANT:
HSING YI PLASTICS PROCESSING CO., LTD.
510(K) NUMBER:
DEVICE NAME:
Synthetic Vinyl Examination Glove, Powdered
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | 1951876 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
ATCH5
EXHIBIT B
Page 2 of 24 (Revised 7/6/98)
§ 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.