(35 days)
Not Found
Not Found
No
The device is a simple examination glove and the description contains no mention of AI or ML.
No
The device, a patient examination glove, is intended for preventing contamination between patient and examiner, not for treating or rehabilitating a medical condition.
No
The device is a patient examination glove, which is used to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical patient examination glove, which is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's classified as a Class I device (21CFR 880.6250) and described as a "Vinyl Patient Examination Glove." This classification and description are consistent with a medical device used for protection, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
- Reagents or assays
The information provided clearly describes a protective barrier device, not a device used for in vitro diagnostic testing.
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) 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.
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 / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance data showing compliance with ASTM D5250-92 for Length, Width, Thickness, Tensile Strength, and Ultimate Elongation (Before and After Aging). Also complies with FDA 1000ml water leak test (Meets AQL 4.0 with an Inspection Level of S-4).
Clinical Performance Data: Modified Draize Test. The 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.)
Not Found
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. 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
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 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.
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 행
The applicant devices conform fully to ASTM D5250-92 and applicable 21 CFR requirements, and meets FDA 1000ml Water Leak Test.
3
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
4
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
5
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)