(28 days)
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Not Found
No
The document describes a standard patient examination glove and makes no mention of AI or ML technology.
No
A therapeutic device is used to treat or cure a disease or condition. This device, a patient examination glove, is intended for preventing contamination, not for treatment.
No
This device is described as a patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description clearly identifies the device as a physical patient examination glove, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: It is classified as Class I under 21 CFR 880.6250, which is the regulation for Patient Examination Gloves. This classification is for general medical devices, not specifically for IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device's function is purely as a physical barrier for infection control during patient examination.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
- (A) Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
- (B) Viryl Patient Examination Glove, Power Free, 80LYZ
- (C) conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Perfomance data: Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Length (mm):
Size S: Min. 230mm (ASTM D5250-92), 240±5mm (Applicant Device)
M: Min. 230mm (ASTM D5250-92), 240±5mm (Applicant Device)
L: Min. 230mm (ASTM D5250-92), 240±5mm (Applicant Device)
XL: Min. 230mm (ASTM D5250-92), 240±5mm (Applicant Device)
Width (mm):
Size S: 85±5mm (ASTM D5250-92), 87±3mm (Applicant Device)
M: 95±5mm (ASTM D5250-92), 97±3mm (Applicant Device)
L: 105±5mm (ASTM D5250-92), 107±3mm (Applicant Device)
XL: 115±5mm (ASTM D5250-92), 114±3mm (Applicant Device)
Thickness (mm):
Finger: Min. 0.05mm (ASTM D5250-92), Min. 0.08mm (Applicant Device)
Palm: Min. 0.08mm (ASTM D5250-92), Min. 0.11mm (Applicant Device)
Physical Properties Before Aging:
Tensile Strength (Mpa): Min. 9Mpa (ASTM D5250-92), Min. 10Mpa (Applicant Device)
Ultimate Elongation (%): Min. 300% (ASTM D5250-92), Min. 300% (Applicant Device)
After Aging:
Tensile Strength (Mpa): Min. 9Mpa (ASTM D5250-92), Min. 9.5Mpa (Applicant Device)
Ultimate Elongation (%): Min. 300% (ASTM D5250-92), Min. 300% (Applicant Device)
FDA Water Leak Test: Meets AQL 4.0 with a Inspection Level of S-4
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
EVERRISE GLOVE PRODUCTS CO., LTD
No. 47, Huan Kung Road, Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C. Nr. 18 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 트
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 그
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
배 Device Name
Vinyl Patient Examination Gloves, Powder Free
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, 2332086 FAX: 886-6-2334439
Page 2 of 3
Device Description 트
- (A) Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
- (B) Viryl Patient Examination Glove, Power Free, 80LYZ
- (C) conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
Application 를
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 이
Non-Clinical Perfomance data
| Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes. | |
|---|---|
| . |
| 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% |
2
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 a | |
| Inspection 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 i
The applicant devices conform fully to ASTM D5250-92 and applicable 21 CFR requirements, and meets FDA 1000ml Water Leak Test.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jason Chang ·General Manager Everrise Glove Products Company, Ltd. No. 47, Huan Kung Road Wanq Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C.
K973998 Re: Vinyl Patient Examination Gloves Powder-Free Trade Name: Requlatory Class: I Product Code: LYZ Dated: October 9, 1997 Received: October 21, 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 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical would 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
Image /page/3/Picture/8 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HI" on the left side and "AN SERVICES USA" on the right side. In the center of the seal is an abstract image of an eagle.
NOV 1 8 1997
4
Page 2 - Mr. Chang
through 542 of the Act for devices under the Electronic cinfough 542 or the not is on other Federal laws or requlations.
This letter will allow you to begin marketing your device as first ibed in your 510 (k) premarket notification. The FDA acperiod in your tial equivalence of your device to a legally rinding of subblancial equivality in a classification for your markees produce, 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) 594-4618. Additionally, for questions on compreator as (advertising of your device, please contact che promocron and lawce at (301) 594-4639. Also, please note ene organs or entitled, "Misbranding by reference to the regaracion cherorou, prematice noorroour 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 W. Ulatowski
Timet my A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
Allachment I b
K972998 510(k) Number (if known):
Device Name:_Patient_Examination_Glove, Powder-Free
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)
.: ienzo S. Macheller, Chus, Zim, PhD
(Division Sign-O tion Control, Division of Dental, Infoc and General Hospital D 5 (J/k) Number
scription Use . cr 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Formal 1-2-96)