(52 days)
A patient examination glove is a disposable device intended for medical purpose which is worn on examiner's hand or finger to prevent contamination between patient and examiner.
(1) Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
(2) Vinyl Patient Examination Glove, Powder Free, 80LYZ
(3) conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
Here's a summary of the acceptance criteria and the study details for the "Vinyl Patient Examination Gloves, Powder Free" manufactured by Universal Gloves Corporation, based on the provided 510(k) submission (K980093).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category/Test | Specified Acceptance Criteria (from ASTM D5250-92 & FDA) | Reported Device Performance (as stated by manufacturer) |
|---|---|---|
| Dimensions | ||
| Length (mm) | Min. 230mm (for all sizes S, M, L, XL) | $240 \pm 5$mm (for all sizes S, M, L, XL) |
| Width (mm) | ||
| Size S | $85 \pm 5$mm | $87 \pm 3$mm |
| Size M | $95 \pm 5$mm | $97 \pm 3$mm |
| Size L | $105 \pm 5$mm | $107 \pm 3$mm |
| Size XL | $115 \pm 5$mm | $114 \pm 3$mm |
| Thickness (mm) | ||
| Finger | Min. 0.05mm | Min. 0.08mm |
| Palm | Min. 0.08mm | Min. 0.11mm |
| Physical Properties | ||
| Before Aging | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 10Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| After Aging | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 9.5Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| Pin-holes (Water Leak Test) | Meets AQL 4.0 with an Inspection Level of S-4 (FDA 1000ml Water Leak Test) | Meets AQL 4.0 with an Inspection Level of S-4 (FDA 1000ml Water Leak Test) |
| Biocompatibility | No clinically significant irritation or allergic contact dermatitis (Modified Draize Test) | Did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects |
Study that Proves the Device Meets Acceptance Criteria:
The provided document describes a non-clinical performance study and a clinical performance study.
2. Sample Size Used for the Test Set and Data Provenance:
- Non-Clinical Performance Data (Physical Properties & Water Leak Test): The document does not explicitly state the sample size used for the mechanical property tests (Length, Width, Thickness, Tensile Strength, Ultimate Elongation) nor for the FDA Water Leak Test. It simply states that the "Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes." and lists the observed performance. ASTM D5250-92 specifies sampling plans, but the specific sample sizes used by the manufacturer are not detailed in this summary.
- Clinical Performance Data (Biocompatibility - Modified Draize Test): The document states "human subjects" were used, but the specific number is not provided.
- Data Provenance: The manufacturing company, Universal Gloves Corporation, is located in Tainan, Taiwan, R.O.C. (Republic of China). All data would originate from studies conducted by or for this manufacturer. The studies are assumed to be prospective as they are assessing the performance of a new device for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- For physical and performance tests (Length, Width, Thickness, Tensile Strength, Elongation, Water Leak Test): No external "experts" in the sense of medical professionals are typically involved in establishing ground truth for these objective physical measurements. The ground truth is established by the specified ASTM standards and FDA test methods themselves, which outline the procedures for measurement and evaluation. The "experts" implementing these would be laboratory technicians or engineers qualified in materials testing and quality control. Their number and specific qualifications are not detailed in the summary.
- For the Clinical Performance (Modified Draize Test): Medical professionals (e.g., dermatologists or clinicians) would be involved in evaluating the skin reactions of human subjects. The number and specific qualifications of these experts are not provided in the summary.
4. Adjudication Method for the Test Set:
- For physical and performance tests: Adjudication is not typically applicable for objective performance tests against a defined standard. Measurements are taken, and results are compared directly to the specified criteria.
- For the Clinical Performance (Modified Draize Test): The method of evaluation would typically involve clinical assessment by qualified personnel. The document does not specify any particular adjudication method (e.g., 2+1, 3+1 consensus).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. The device in question is a medical glove, which does not involve "readers" or "cases" in that context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This question is not applicable to this device. A medical glove is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.
7. Type of Ground Truth Used:
- For physical and performance tests: The ground truth is based on established industry standards and regulatory test methods. Specifically, ASTM Standard D5250-92 details the required physical properties and dimensions for vinyl patient examination gloves, and the FDA 1000ml Water Leak Test specifies the method for pin-hole detection.
- For biocompatibility: The ground truth for biocompatibility (irritation and sensitization) is established through clinical observation and assessment by qualified medical professionals using the Modified Draize Test on human subjects.
8. Sample Size for the Training Set:
- This question is not applicable as an AI/ML algorithm is not involved in this device or its development. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- This question is not applicable as there is no training set.
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UNIVERSAL GLOVES CORPORATIO
Shin Ying Industrial Zone No. 10, Shin Jiunn Road, Shin Ying, Tainan, Taiwan, R.O.C. FAX: 886-6-6525105 TEL: 886-6-6525101-4
510(K) SUMMARY
Date : December 20, 1997
K980093
Applicant 1.
Universal Gloves Corporation
No. 10, Shin Jiunn Road, Shin Ying Industrial Zone, Shin Ying, Tainan Hisien, Taiwan, R.O.C. Tel : 886-6-6525101 (4 lines) Fax : 886-6-6525105
2. Contact Person
Mr. John Chen
No. 10, Shin Jiunn Road, Shin Ying Industrial Zone, Shin Ying, Tainan Hsien, Taiwan, R.O.C. Fax : 886-6-6525105 Tel : 886-6-6525101 (4 lines)
3. Device Name
Vinyl Patient Examination Gloves, Powder Free
Device Description 4.
(1) Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
(2) Vinyl Patient Examination Glove, Powder Free, 80LYZ
(3) conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
ડ. Application
The applicant device is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Comparison to Predicate Device ర్.
Non-Clinical Performance data
Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes.
AST Pest Catalog | CASTM DS250-91 | Cast | Appli and and the program of the
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UNIVERSAL GLOVES CORPORATION
Shin Ying Industrial Zone
No. 10, Shin Jiunn Road, Shin Ying, Tainan, Taiwan, R.O.C.
TEL: 886-6-6525101-4 FAX: 886-6-6525105
| Length (mm) | ||
|---|---|---|
| Size S | Min. 230mm | $240\pm5mm$ |
| M | Min. 230mm | $240\pm5mm$ |
| L | Min. 230mm | $240\pm5mm$ |
| XL | Min. 230mm | $240\pm5mm$ |
| Width (mm) | ||
| Size S | $85\pm5mm$ | $87\pm3mm$ |
| M | $95\pm5mm$ | $97\pm3mm$ |
| L | $105\pm5mm$ | $107\pm3mm$ |
| XL | $115\pm5mm$ | $114\pm3mm$ |
| Thickness (mm) | ||
| Finger | Min. 0.05mm | Min. 0.08mm |
| Palm | Min. 0.08mm | Min. 0.11mm |
| Physical Properties | ||
| Before Aging | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 10Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| After Aging | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 9.5Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| FDA Water Leak Test | Meets AQL 4.0 with aInspection Level of S-4 |
Clinical Performance Data
The results of Modified Draize Test suggest the applicant device did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects.
Conclusion 7.
The applicant devices conform fully to ASTM I>5250-92 and applicable 21 CFR requirements, and meets FDA 1000ml Water Leak Test.
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 1998
Mr. John Chen Chief Engineer Universal Gloves Corporation 10 Shin Jiunn Road Shin Ying Industrial Zone Shin Ying, Tainan Hsien China (TAIWAN)
K980093 Re : Vinyl Patient Examination Gloves, Powder Trade Name: Free Requlatory Class: I LYZ Product Code: February 5, 1998 Dated: February 18, 1998 Received:
Dear Mr. Chen:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Chen
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.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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) 63&(2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo ChWA. VIT at c Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
980093 510(k) Number (if known):
Device Name: Vinyl Patient Examination Glove, Powder Free
Indications For Use:
A patient examination glove is a disposable device intended for medical purpose which is worn on 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)
Rauced by Clin
51 Olk) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Formal 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.