(44 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard medical glove, with no mention of AI or ML capabilities. The performance studies focus on biocompatibility and water leak tests, which are standard for this type of device.
No
The device, a medical glove, is intended to prevent contamination and is not described as providing any therapeutic effect like treating or preventing a disease or condition for the patient.
No
This device, a medical glove, is intended to prevent contamination and is not described as analyzing or interpreting data to diagnose a medical condition.
No
The device description clearly states it is a physical medical glove, which is a hardware device. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details a Class I Latex Patient Examination Glove, which is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on biocompatibility (skin irritation and sensitization) and barrier integrity (water leak test), which are relevant to a protective glove, not an IVD.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This glove's function is purely protective and preventative.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LYY
Device Description
Class I Latex Patient Examination Glove 80 LYL, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-95 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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)
Dimensions:
- X Small: 73 - 78 mm (ASTM D 3578-95: 70 mm +/- 10 mm)
- Small: 83 - 88 mm (ASTM D 3578-95: 80 mm +/- 10 mm)
- Medium: 93 - 98 mm (ASTM D 3578-95: 90 mm +/- 10 mm)
- Large: 103 - 107 mm (ASTM D 3578-95: 100 mm +/- 10 mm)
- Length: 240 mm minimum for all sizes (ASTM D 3578-95: 230 mm minimum for all sizes)
- Thickness – finger: 0.10 mm minimum (ASTM D 3578-95: 0.08 mm minimum)
- Palm: 0.10 mm minimum (ASTM D 3578-95: 0.08 mm minimum)
Tensile Strength / Ultimate Elongation:
- BEFORE AGING:
- Tensile Strength: 26.7 Mpa (ASTM D3578-95: 14.0 Mpa.)
- Ultimate Elongation: 840% (ASTM D3578-95: 700%)
- AFTER AGING (7 days at 70):
- Tensile Strength: 21.8 Mpa (ASTM D3578-95: 14.0 Mpa.)
- Ultimate Elongation: 820% (ASTM D3578-95: 500%)
Our gloves meets all the specifications of the ASTM D3578-95 Standards.
Water Tight Test:
- Method: FDA water leak test method, 80 pieces of gloves tested at AQL 4.0% General Inspection II multiple sampling plan.
- Results:
- Batch 70881981 (Large): 80 samples, 1 unit leak, Accepted.
- Batch 70881962 (Medium): 80 samples, 1 unit leak, Accepted.
- Batch 70882003 (Small): 80 samples, 0 unit leak, Accepted.
The test meets the FDA Water Leak Test Requirements.
Biocompatibility:
- Tests: Primary Dermal Irritation Test and Skin Sensitization Study.
- Results: The gloves pass the the Biocompatibility Tests.
Water Soluble Protein Test by ASTM D5712 standards:
- Batch No. Production Date: 1. R123-5L5M (03/09/97) Medium
- Protein Content ug/g (against OVBM): 209
There is no Label Claim on Protein Level.
Conclusion:
Evergreen Non-Strile, Latex Examination Gloves meet:
- ASTM D3578-95 --Standard.
- FDA Water Leak Test requirements.
- ASTM D5151 -90 Test method for Detection of Holes in Medical Gloves.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirements of ASTM Standard D3578-95
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows a black and white drawing of a symbol. The symbol is symmetrical and features a horizontal curved line at the top. Below the curved line is a rectangular shape with two vertical lines on either side. The symbol has a simple and minimalist design.
1
YTY INDUSTRY (MANJUNG) SDN. BHD.
(Company No : 380830-P) (Company No : 00000 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Eol 1422-1424, Bula 166ing Line), 6792443 & 6792445 Fax : 05-6791188
APPENDIX H
DEC 2 4 1997
510 (K) SUMMARY
| 2 | Sumitter
YTY Industry (Manjung) Sdn Bhd
Lot 1422-1424, Batu 10 Lekir,
32020 Sitiawan
Perak Darul Ridzuan,
Malaysia. |
|-----|------------------------------------------------------------------------------------------------------------------------------------|
| Tel | 605-6792288 |
| Fax | 605-6791188 |
Name of contact Paerson 1. MR. MOH UNG NANG
Date of Summary Prepared
September 20, 1997
3 Name Of Device
| Trade Name | Evergreen Non-Sterile Powdered Latex Examination Gloves |
|---|---|
| Common Name | Exam Gloves |
| Classification Name | Patient Examination Glove |
4 ldentification of The Legally Marketed Devices
Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirements of ASTM Standard D3578-95
5 Description Of The Device
Class I Latex Patient Examination Glove 80 LYL, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-95 and FDA Water Leak Test.
1
The Intended Use Of GLove 6.0
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
7.0 Technoligical Chracteristic of Device.
Dimensions A.
| DIMENSION | ASTM D 3578-95 | EVERGREEN GLOVE |
|---|---|---|
| X Small | 70 mm +/- 10 mm | 73 - 78 mm |
| Small | 80 mm +/- 10 mm | 83 - 88 mm |
| Medium | 90 mm +/- 10 mm | 93 - 98 mm |
| Large | 100 mm +/- 10 mm | 103 - 107 mm |
| Length | 230 mm minimum | |
| for all sizes | 240 mm minimum | |
| for all sizes | ||
| Thickness – finger | 0.08 mm minimum | 0.10 mm minimum |
| Palm | 0.08 mm minimum | 0.10 mm minimum |
B.
| TEST | TENSILE STRENGTH | ULTIMATE ELONGATION | ||
|---|---|---|---|---|
| ASTM | YTY'S | ASTM | YTY'S | |
| D3578-95 | Gloves | D 3578-95 | Gloves | |
| BEFORE AGING | 14.0 Mpa. | 26.7 Mpa | 700% | 840% |
| AFTER AGING | ||||
| 7 days at 70 | 14.0 Mpa. | 21.8 Mpa | 500% | 820% |
Our gloves meets all the specifications of the ASTM D3578-95 Standards.
2
C. WATER TIGHT TEST
FDA water leak test method is used to test 80 pieces of gloves at AQL 4.0% General Inspection II multiple sampling plan. The results are as follows:
| Batch | Size | Sample Size | Unit Leak | Disposition |
|---|---|---|---|---|
| 70881981 | Large | 80 | 1 | Accepted |
| 70881962 | Medium | 80 | 1 | Accepted |
| 70882003 | Small | 80 | 0 | Accepted |
The test meets the FDA Water Leak Test Requirements.
BIOCOMPATIBILITY ப்
The test consists of Primary Dermal Irritation Test and Skin Sensitization Study.
The gloves pass the the Biocompatibility Tests.
E. Water Soluble Protein Test by ASTM D5712 standards.
| Batch No. Production Date | Protein Content ug/g
(against OVBM) |
|-----------------------------------|----------------------------------------|
| 1. R123-5L5M
(03/09/97) Medium | 209 |
There is no Label Claim on Protein Level.
Conclusion.
We concluded that Evergreen Non-Strile, Latex Examination Gloves meet:
- ASTM D3578-95 --Standard.
- -FDA Water Leak Test requirements.
- ASTM D5151 -90 Test method for Detection of Holes in Medical Gloves. -
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is represented by three intertwined human profiles. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 4 1997
Mr. Leonard Frier ·President YTY Industry Sdn. Bhd. C/O MET Laboratories 914 West Patapsco Avenue Baltimore, Maryland 21230-3432
K974191 Re : Everqreen Non-Sterile Powdered Latex Trade Name: Examination Glove Requlatory Class: I Product Code: LYY December 18, 1997 Dated: Received: December 19, 1997
Dear Mr. Frier:
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, Druq, 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 reqistration, 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 Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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
4
Page 2 - Mr. Frier
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 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Applicant : YTY INDUSTRY (MANJUNG ) SDN BHD
510K Number : Poli 22 personal program and the production of the comments of the comments of the comments of the comments of the country of the country of the country of the country of the Device Name : Evergreen Latex Examination Gloves ર
Indications For Use :
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K974191 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter |
|---|---|---|
| Per 21 CFR 801.109 |