(31 days)
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.
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 provided text is a 510(k) summary for a medical device, specifically non-sterile powder-free polymer-coated latex examination gloves. It details the device's technical specifications and how its performance was evaluated against established standards for regulatory clearance. It does not describe a study involving an AI-powered device or human readers.
Therefore, many of the requested categories regarding AI, expert involvement, and MRMC studies are not applicable to this document.
Here's the information that can be extracted from the provided text, structured according to your request where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-95) | Reported Device Performance (EVERGREEN POWDER FREE LATEX EXAM. GLOVES) |
|---|---|---|
| Watertight (1000ml) | GII, AQL = 4.0% | Pass GII, AQL = 4.0% |
| Length (mm) - XS, S, M, L, XL | Min 230 for all sizes | 240 mm minimum for all sizes |
| Palm width (mm) - S | 80 ± 10 | 83 - 88 |
| Palm width (mm) - M | 95 ± 10 | 93 - 98 |
| Palm width (mm) - L | 111 ± 10 | 103 - 107 |
| Palm width (mm) - XS, XL | - (Not specified in standard for these sizes) | 73 - 78 (XS), N/A (XL, value not given for XL) |
| Thickness (mm) (Single Layer) - Finger | Min 0.08 | Min 0.10 |
| Thickness (mm) (Single Layer) - Palm | Min 0.08 | Min 0.10 |
| Physical Properties (Before Aging) - Tensile Strength (Mpa) | Min 14 | 23 - 27 |
| Physical Properties (Before Aging) - Ultimate Elongation (%) | Min 700 | 830 - 870 |
| Physical Properties (After Aging) - Tensile Strength (Mpa) | Min 14 | 23 - 26 |
| Physical Properties (After Aging) - Ultimate Elongation (%) | Min 500 | 820 - 850 |
| Powder Content | - (FDA Requirements: below 2 mg/glove by implication from conclusion) | Below 2 mg/glove |
| Protein Content | - (Label claim: ≤ 50 micrograms/gram of glove) | Below 50 microgram/gram |
| Bio-compatibility Test | Pass (implied requirement for medical devices) | Passed Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves) used for each individual test. It states that "Performance data of gloves based on ASTM D3578-95 and FDA 1000ML watertight test" were conducted. ASTM standards typically define sampling plans, which would have been followed, but the specific numbers are not in this summary.
Data Provenance: The testing was conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia). The data would be prospective, as it was generated specifically for this 510(k) submission to demonstrate compliance with the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is defined by physical and chemical performance standards (ASTM D3578-95 and FDA requirements), not expert consensus on interpretations of data. The tests are objective measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring expert adjudication of results. The tests are based on direct measurement and comparison against predefined thresholds in standards.
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
Not applicable. This is not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is defined by established industry standards (ASTM D3578-95) and regulatory requirements (FDA's 1000ML watertight test, powder content, and protein content limits). These are objective, measurable criteria for glove performance.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
{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 BhdLot 1422-1424, Batu 10 Lekir32020 SitiawanPerak Darul RidzuanMALAYSIA |
| 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 FREELATEX EXAM. GLOVES |
|---|---|---|
| 1. Watertight (1000ml) | GIIAQL = 4.0% | Pass GIIAQL = 4.0% |
| 2. Length (mm)SizeXSSMLXL | Min 230Min 230Min 230Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm)SizeXSSMLXL | -80 + 1095 + 10111 + 10- | 73 - 7883 - 8893 - 98103 - 107 |
| 4. Thickness (mm)(Single Layer)FingerPalm | Min 0.08Min 0.08 | Min 0.10Min 0.10 |
| 5. Physical PropertiesBefore AgingTensile Strength (Mpa)Ultimate Elongation (%)After Aging | Min 14Min 700 | 23 - 27830 - 870 |
| Tensile Strength (Mpa)Ultimate Elongation (%) | Min 14Min 500 | 23 - 26820 - 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
§ 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.