(31 days)
Not Found
Not Found
No
The device description and performance data focus on the physical properties and barrier function of a standard medical glove, with no mention of AI or ML capabilities.
No
The device is a medical glove intended to prevent contamination between healthcare personnel and the patient. It does not provide any therapeutic benefit or treatment. Its function is to create a barrier, which is a preventative measure, not a therapeutic one.
No
A medical glove is a barrier device used to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a "Class 1 Latex Patient Examination Glove," which is a physical hardware device. The performance studies and key metrics also relate to the physical properties of the glove.
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 "medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description details a "Class 1 Latex Patient Examination Glove," which is a physical barrier.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
- Performance Data: The performance data focuses on physical properties like watertightness, dimensions, thickness, tensile strength, and biocompatibility, which are relevant to a glove's function as a barrier, not its diagnostic capabilities.
In summary, the device is a medical glove intended for barrier protection, not for performing diagnostic tests on biological samples.
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 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements 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
Performance data of gloves based on ASTM D3578-95 and FDA 1000ML watertight test.
Tests performed include:
- Watertight (1000ml) - Pass GII AQL = 4.0%
- Length (mm) - 240 mm minimum for all sizes
- Palm width (mm) - XS: 73-78, S: 83-88, M: 93-98, L: 103-107, XL: Not Found
- Thickness (mm) (Single Layer) Finger: Min 0.10, Palm: Min 0.10
- Physical Properties Before Aging Tensile Strength (Mpa): 23-27, Ultimate Elongation (%): 830-870 ; After Aging Tensile Strength (Mpa): 23-26, Ultimate Elongation (%): 820-850
- Powder Content - Below 2 mg/glove
- Protein Content - Below 50 microgram/gram
The performance data meet the ASTM D3578-95 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. The protein content tested on accelerated aging gloves is
§ 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
(TY INDUSTRY (MANJUNG) SDN. BHD.
Company No : 380830-P) 1422-1424. Batu 10 Lekir. 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
- JUN 2 1 1999
K991742
PENDTX .J
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | 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 Person | 1. MR. MOH UNG NANG | |
| Date of Summary Prepared | April 27, 1999 | |
| 3.0 | Name of Device |
| Trade Name : | Non-Sterile Powder Free Polymer Coated Latex Examination Glove |
|---|---|
| (Evergreen & Multiple Private Labels) |
- Common Name Exam Glove
Classification Name Patient Examination Glove
4.0 Identification of The Legally Marketed Devices
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.
5.0 Description of The Device
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.
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.
Page 1 of 3
1
7.0 Summary of Performance Data:
Performance data of gloves based on ASTM D3578-95 and FDA 1000ML watertight test.
| TEST | ASTM D3578-95 | EVERGREEN POWDER FREE
LATEX EXAM. GLOVES |
|------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------|
| 1. Watertight (1000ml) | GII
AQL = 4.0% | Pass GII
AQL = 4.0% |
| 2. Length (mm)
Size
XS
S
M
L
XL | Min 230
Min 230
Min 230
Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm)
Size
XS
S
M
L
XL | -
80 + 10
95 + 10
111 + 10
- | 73 - 78
83 - 88
93 - 98
103 - 107 |
| 4. Thickness (mm)
(Single Layer)
Finger
Palm | Min 0.08
Min 0.08 | Min 0.10
Min 0.10 |
| 5. Physical Properties
Before Aging
Tensile Strength (Mpa)
Ultimate Elongation (%)
After Aging | Min 14
Min 700 | 23 - 27
830 - 870 |
| Tensile Strength (Mpa)
Ultimate Elongation (%) | Min 14
Min 500 | 23 - 26
820 - 850 |
| 6. Powder Content | - | Below 2 mg/glove |
| 7. Protein Content | - | Below 50 microgram/gram |
:
2
- The performance data of the glove as shown above meet the ASTM D3578-95 Standard 8.0 and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. The protein content tested on accelerated aging gloves is ≤ 50 mg/gram.
- The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig 9.0 Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion
We concluded that the Multiple Private Labeled Non-Sterile, Powder Free Polymer Coated Latex Examination Gloves meet:
- ASTM D3578-95 Standard -
- FDA pinhole requirements -
- FDA minimum Powder Residual Content. -
- Label Claim of maximum 50 micrograms per gram of glove or less for water -Extractable Protein.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wavy lines representing wings or snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 1999
YTY Industry (Manjung) Sdn. Bhd. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 21114 Crofton, Maryland
K991742 Re : Non-Sterile, Powder Free, Polymer Coated Trade Name: Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY May 10, 1999 Dated: Received: May 21, 1999
Dear Mr. Smith:
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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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.
4
Page 2 - Mr. Smith
this response to your premarket notification Please note: 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 regulations.
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) 594-4692. 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,
Timothy A. Ulatowski
Director
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:
with Protein Content labeling Claim of 50 microgram or le Device Name: Non-Sterile Powder Free Polymer Coated Latex Examination Glove SA Evergreen & Multiple Private Labeled)
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)
Prescription Use ...................... Per 21 CFR 801.109
Over-The-Counter ...
Qlin S. tim
OR
510(k) Num