(35 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.
Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250. Vinyl Patient Examination Glove, 80LYZ, Powdered with an absorbable dusting starch powder, USP, Class III. conform to all requirements of ASTM Standard D5250-92 and FDA 1000ml water leak test.
This is a 510(k) summary for Vinyl Patient Examination Gloves, Powdered. It describes the device, its intended use, and compares its performance to the ASTM D5250-92 standard and the FDA 1000ml water leak test.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (ASTM D5250-92) | Reported Device Performance |
|---|---|---|
| Length (mm) | ||
| Size S | Min. 230mm | 240±5mm |
| Size M | Min. 230mm | 240±5mm |
| Size L | Min. 230mm | 240±5mm |
| Size XL | Min. 230mm | 240±5mm |
| Width (mm) | ||
| Size S | 85±5mm | 87±3mm |
| Size M | 95±5mm | 97±3mm |
| Size L | 105±5mm | 107±3mm |
| Size XL | 115±5mm | 114±3mm |
| 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% |
| Physical Properties (After Aging) | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 9.5Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| FDA Water Leak Test | Meets | Meets AQL 4.0 with an Inspection Level of S-4 |
Study Proving Device Meets Acceptance Criteria:
The document states that the "Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes." It also mentions a "Modified Draize Test" for clinical performance.
2. Sample size used for the test set and the data provenance
- Non-Clinical Performance Data (Physical Properties and Water Leak Test): The document does not specify the exact sample sizes used for each of the physical property tests (length, width, thickness, tensile strength, elongation). For the FDA Water Leak Test, it mentions an "Inspection Level of S-4," which is a sampling plan specification, but not the absolute number of gloves tested.
- Clinical Performance Data (Modified Draize Test): The document refers to "human subjects" but does not specify the number of subjects used in the Modified Draize Test.
- Data Provenance: The document is from Everrise Glove Products Co., Ltd. in Tainan Hsien, Taiwan, R.O.C. The data appears to be prospective testing conducted by the manufacturer to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are objective measurements against defined standards (ASTM D5250-92 and FDA 1000ml water leak test) and a standardized skin irritation test (Modified Draize Test). These do not typically involve human expert "ground truth" establishment in the way medical imaging or diagnostic algorithms do.
4. Adjudication method for the test set
This is not applicable as the tests performed are objective measurements against established standards, not subjective interpretations requiring adjudication.
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
This is not applicable as the device is a vinyl patient examination glove, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical product (gloves), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance data is defined by the ASTM Standard D5250-92 specifications and the FDA 1000ml water leak test criteria. For the clinical performance, the "ground truth" is the lack of clinically significant irritation or allergic contact dermatitis as determined by the Modified Draize Test. This is based on direct observation of human physiological reactions rather than expert consensus on subjective data or pathology.
8. The sample size for the training set
This is not applicable. The context is a medical device (gloves) undergoing testing against established standards, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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EVERRISE GLOVE PRODUCTS CO., LTD
No. 47, Huan Kung Road, Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C. NDV 1 8 1997 TEL: 886-6-2330946, 2332086 FAX: 886-6-2334439
510(K) Summary
Page 1 of 3
Date of summary prepared : October 9th, 1997
Applicant 1
Everrise Glove Products Co., Ltd. No. 47, Huan Kung Road Wang Haun Li Yung Kang City Tainan Hsien Taiwan, R.O.C. Tel : 886-6-2330946 886-6-2332086 Fax : 886-6-2334439
Contact Person 1
Mr. Jason Chang No. 47, Huan Kung Road Wang Haun Li Yung Kang City Tainan Hsien Taiwan, R.O.C. Tel : 886-6-2330946 886-6-2332086 Fax : 886-6-2334439 E-Mail : everrise@ms14.hinet.net
Device Name 1
Vinyl Patient Examination Gloves, Powdered
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EVERRISE GLOVE PRODUCTS CO., LTD
No. 47, Huan Kung Road, Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C. TEL: 886-6-2330946, 2332086 FAX: 886-6-2334439
Page 2 of 3
Device Description 를
- (A) Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
- (B) Vinyl Patient Examination Glove, 80LYZ, Powdered with an absorbable dusting starch powder, USP, Class III.
- (C) conform to all requirements of ASTM Standard D5250-92 and FDA 1000ml water leak test.
Application 방
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 를
Non-Clinical Perfomance data
| Test | ASTM D5250-92 | Applicant Device |
|---|---|---|
| Length (mm) | ||
| Size S | Min. 230mm | 240±5mm |
| M | Min. 230mm | 240±5mm |
| L | Min. 230mm | 240±5mm |
| XL | Min. 230mm | 240±5mm |
| Width (mm) | ||
| Size S | 85±5mm | 87±3mm |
| M | 95±5mm | 97±3mm |
| L | 105±5mm | 107±3mm |
| XL | 115±5mm | 114±3mm |
| 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% |
Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes.
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EVERRISE GLOVE PRODUCTS CO., LTD
No. 47, Huan Kung Road, Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C. TEL: 886-6-2330946, 2332086 FAX: 886-6-2334439
Page 3 of 3
| 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 행
The applicant devices conform fully to ASTM D5250-92 and applicable 21 CFR requirements, and meets FDA 1000ml Water Leak Test.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services in the USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human face or profile, possibly representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1997
Mr. Jason Chanq General Manager Everrise Glove Products Company, Ltd. No. 47, Huan Kung Road Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C.
Re : K973902 Trade Name: Vinyl Patient Examination Gloves Powdered Regulatory Class: I Product Code: LYZ Dated: October 9, 1997 Received: October 14, 1997
Dear Mr. Chang:
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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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 - Mr. Chang
through 542 of the Act for devices under the Electronic enroagle Siz of 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 yitro 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Tim A. Whetstone
Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Altachment I b
of I l Page
| 510(k) Number (if known): | KG13902 |
|---|---|
| --------------------------- | --------- |
_cvice Name:_Patient Examination Glove, Powdered
Indications For Use:
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)
George J. Mueller, Jr. (Kim S. Tan, Ph.D
(Divisio Division and Gene 510(k) Num
Prescription Use (Per 21 CFR 801.109)
.
OR
Over-The-Counter Use
(Optional Format 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.