(31 days)
This powder-free vinyl exam glove is intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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 powder-free vinyl exam gloves. They are non-sterile, single use, disposable gloves.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GLORMED INTERNATIONAL, INC. VINYL EXAMINATION GLOVE, POWDER-FREE:
It's important to note that this document is a 510(k) Summary for a medical glove, which is a relatively low-risk device. The regulatory requirements and the nature of the "study" for such devices are much simpler than for complex AI-powered diagnostic tools. Therefore, many of the requested categories (like MRMC studies, ground truth establishment for training data, number of experts for ground truth, etc.) are not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Device Performance |
|---|---|
| ASTM D5250 | Met and/or exceeded the requirements. (This standard specifies requirements for medical grade vinyl examination gloves.) |
| Primary Skin Irritation Study | Met and/or exceeded the requirements. (Implies no significant primary skin irritation was observed.) |
| Dermal Sensitization Study | Met and/or exceeded the requirements. (Implies no significant dermal sensitization was observed.) |
| FDA Water Leak, before & after aging | Met and/or exceeded the requirements. (This test assesses the integrity of the glove to prevent leakage, both initially and after simulated aging, which is critical for barrier protection. The specific threshold is not provided.) |
Study Details
Given the nature of the device (a vinyl examination glove), the "study" is a series of laboratory tests to demonstrate compliance with relevant standards and safety requirements.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. For physical property tests like water leak, ASTM standards typically specify a sampling plan (e.g., AQL levels). For biocompatibility tests (skin irritation, sensitization), testing is typically done on a representative biological model or a small group of human volunteers.
- Data Provenance: Not specified, but the tests were performed "in a certified testing laboratory." The country of origin of the data is not mentioned, but it's presumed to be from a laboratory that can provide data acceptable to the FDA for a US market submission. The tests are prospective in the sense that they were conducted specifically for this device submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For physical and chemical tests of a medical glove, "ground truth" is established by the objective physical and chemical properties of the glove itself, as measured by standard laboratory procedures. Biocompatibility studies are typically evaluated by toxicologists or dermatologists, but the number of "experts" for ground truth adjudication in the AI sense is not relevant here.
4. Adjudication method for the test set:
- Not Applicable. As per point 3, adjudication in the context of expert consensus for AI is not relevant for these types of lab tests. The tests have pass/fail criteria based on 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 physical product (medical glove), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used:
- Objective Test Results against Standards. The "ground truth" for the performance claims of the glove is the objective data obtained from the specified laboratory tests (e.g., water leak test, tensile strength implicit in ASTM D5250, results of irritation and sensitization studies) compared against the acceptance criteria defined by the relevant ASTM standards and FDA requirements.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for a physical device.
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NOV 5 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
GLORMED INTERNATIONAL, INC VINYL EXAMINATION GLOVE, POWDER-FREE
| Submitter: | Janna Tucker & Associates198 Avenue de la D'emeraldSparks, NV 89434 | ||
|---|---|---|---|
| PHONE: | (702) 342-2612 | ||
| FAX: | (702) 342-2613 | ||
| Contact Person: | Janna P. Tucker, President, Janna Tucker & Associates | ||
| Date Prepared: | September 30, 1998 | ||
| Trade Name: | (Multiple) Vinyl Examination Glove, Powder-Free | ||
| Common Name: | Vinyl Exam Glove, Powder-Free | ||
| Classification Name: | Patient Examination Glove, Class I, 80LYZ | ||
| Summary of Safetyand Effectiveness: | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug and Cosmetic Act,respecting safety and effectiveness is summarized below. Forthe convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule ". . . (510(k) Summariesand 510(k) Statements . . ." (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requestingit from the preparer. | ||
| NEW DEVICE NAME: VINYL EXAMINATION GLOVE,POWDER-FREE | |||
| PREDICATE DEVICE NAME: Vinyl Exam Glove, Powdered,K981360, everything is thesame process except for addingpowder to finished glove. | |||
| Device Description: | The device is powder-free vinyl exam gloves. They are non-sterile, single use, disposable gloves. | ||
| Intended Use: | This powder-free vinyl exam glove is intended for medicalpurposes that is worn on the examiner's hand or finger to preventcontamination between patient and examiner. |
EXHIBIT I
Page 50 of 51
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| Indications Statement: A patient examination glove is a disposable device intended formedical purposes that is worn on the examiner's hand or finger toprevent contamination between patient and examiner. | |
|---|---|
| TechnologicalCharacteristics | This vinyl exam glove has the same technologicalcharacteristics as predicate devices. The device is manufactured instandard sizes. |
| Performance Data: | The device has met and/or exceeded the requirements of thefollowing standards and laboratory tests: |
| ASTM D5250Primary Skin Irritation StudyDermal Sensitization StudyFDA 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 CFR807) and the information provided herein, we conclude that thedevice is substantially equivalent to other like devices under theFederal Food, Drug, and Cosmetic Act. The predicate deviceis the powdered vinyl glove of Glormed International, Inc.,(К981360), except it is this new glove is powder-free. |
JANNA P. TUCKER, President Janna Tucker & Associates Official Correspondent for Glormed International, Inc.
EXHIBIT I
Page 51 of 51
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a caduceus or a staff with snakes, representing health and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 NOV
Glormed International, Incorporated C/O Ms. Janna P. Tucker President Janna Tucker & Associates 198 Avenue de la D'Emerald Sparks, Nevada 89434
K983494 Re : Vinyl Exam Gloves, Powder-Free Trade Name: Regulatory Class: I Product Code: LYZ Dated: September 30, 1998 Received: October 5, 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 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). 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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (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 regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 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/dsma/dsmamain.html".
Sincerely yours, untin imothy 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: GLORMED INTERNATIONAL, INC.
K983494 510(K) NUMBER:
:
Vinyl Examination Glove, Powder-Free DEVICE NAME:
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 | K983494 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use X |
|---|---|---|
| ------------------------------------------ | ---- | ------------------------ |
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 51
§ 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.