(10 days)
This is a medical glove worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I Latex Patient Examination Glove 80 LYY, powder free that meets all of the requirements of ASTM Standard D3578-95 and FDA Water leak test.
The provided text describes the acceptance criteria and performance data for Evergreen Non-Sterile Powder Free Latex Examination Gloves.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3578-95 & FDA) | Reported Device Performance (EVERGREEN POWDER FREE LATEX EXAMINATION GLOVE) |
|---|---|---|
| Watertight (1000ml) | G II AQL = 4.0% | Pass G II AQL = 4.0 % |
| Length (mm) | ||
| Size XS, S, M, L | Min 230 | 240 mm minimum for all sizes |
| Size XL | - | (Not specified, but covered by "all sizes") |
| Palm Width (mm) | ||
| Size XS | - | 73 - 78 |
| Size S | 80 +/- 10 | 83 - 88 |
| Size M | 95 +/- 10 | 93 - 98 |
| Size L | 111 +/- 10 | 103 - 107 |
| Size XL | - | (Not specified, but presumably within ranges if offered) |
| Thickness (mm) (Single Layer) | ||
| Finger | min 0.08 | 0.10 minimum |
| Palm | min 0.08 | 0.10 minimum |
| Physical Properties - Before Ageing | ||
| Tensile Strength (Mpa) | min 14 | 26.5 |
| Ultimate Elongation (%) | min 700 | 810 |
| Physical Properties - After Ageing | ||
| Tensile Strength (Mpa) | min 14 | 22.3 |
| Ultimate Elongation (%) | min 500 | 750 |
| Powder Content | (FDA Requirements) | below 2 mg / glove |
| Protein Content | - | below 50 microgram / gram |
| Biocompatibility Tests (Primary Dermal Irritation, Guinea Pig Sensitization) | (Pass) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for watertightness, length, etc.). It refers to "Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test." and the results presented in the summary tables.
The data provenance is retrospective in the context of the 510(k) submission, as the tests have already been performed and the results are being presented.
The country of origin for the data is implied to be Malaysia, as the submitter, YTY Industry (Manjung) Sdn Bhd, is located in Malaysia.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes performance testing for medical gloves against established standards (ASTM D3578-95 and FDA requirements), not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is defined by the objective measurements performed according to these standards.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective measurements against predefined standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. The described device is a medical glove, for which such a study is not appropriate.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study was not done (or is not applicable). The device itself is a physical product (a glove), not an algorithm. The performance data presented in the table are the standalone performance of the glove itself against physical and chemical specifications.
7. Type of Ground Truth Used
The ground truth used is based on objective measurements and adherence to established industry standards and regulatory requirements. Specifically:
- ASTM D3578-95 Standard: This standard provides specifications for latex examination gloves, defining acceptable ranges for properties like watertightness, dimensions, and physical properties (tensile strength, elongation).
- FDA Pinhole Requirements (1000ml watertight test): A specific regulatory requirement for glove integrity.
- FDA Minimum Powder Residual Content: A regulatory requirement for the amount of powder on the glove.
- Biocompatibility Tests: Standards-based tests to assess the biological safety of the material.
8. Sample Size for the Training Set
This information is not applicable. The described device is a physical product (a glove) and does not involve AI or machine learning algorithms that would require a "training set." The manufacturing process of gloves does not involve a "training set" in the context of AI development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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INDUSTRY (MANJUNG) SON. BH
any No : 380830-P
Company No . Socorry Lot 1422-1424, Balu 10 Lokir, 02020 Ghildhan, Freiz : 05-678111
510 (K) SUMMARY
YTY Industry (Manjung) Sdn Bhd Submitter Lot 1422-1424 , Batu 10 Lekir, 32020 Sitiawan. Perak Darul Ridzuan, MALAYSIA.
605-6792288 Tel
605-6791188 Fax
- MR MOH UNG NANG Name of Contact Person
Date of Summary Prepared September 25, 1997
Name Of Device ... 3.0
1.0
2.0
ﺎ ﻳﻮﻧﻴﻮ ﺍﻟ
Trade Name
Evergreen Non-Sterlie Powder Free Latex Examination Glove -Natural Color Evergreen Non-Sterile Powder Free Latex Examination Glove -Pink Evergreen Non-Sterile Powder Free Latex Examination Glove -Blue
Exam Glove Common Name
.
Patient Examination Glove Classification Name
Identification of The Legally Marketed Devices 4.0
Class I Latex. Patient Examination Glove 80 LYY, powder free that meets all of the requirements of ASTM Standard D3578-95 and FDA requirements.
Description Of The Device 5.0
Class | Latex Patient Examination Glove 80 LYY.powder free that meets all of 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 enviroment
Page 1 of 3
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Summary of Performance Data : 7.
ুমু
.. ..
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-95 | EVERGREEN POWDER FREELATEX EXAMINATION GLOVE | |
|---|---|---|---|
| 1. | Watertight (1000ml) | G II AQL=4.0% | Pass G II AQL= 4.0 % |
| 2. | Length (mm) | ||
| Size XS | Min 230 | 240 mm minimum forall sizes | |
| S | Min 230 | ||
| M | Min 230 | ||
| L | Min 230 | ||
| XL | - | ||
| 3. | Palm width (mm) | ||
| Size XS | - | 73 - 78 | |
| S | $80 +- 10$ | 83 - 88 | |
| M | $95 +- 10$ | 93 - 98 | |
| L | $111 +- 10$ | 103 - 107 | |
| XL | |||
| 4. | Thickness (mm)(Single Layer) | ||
| Finger | min 0.08 | 0.10 minimum | |
| Palm | min 0.08 | 0.10 minimum | |
| 5. | Physical Properties. | ||
| Before Ageing | |||
| Tensile Strength (Mpa) | min 14 | 26.5 | |
| Ultimate Elongation (%) | min 700 | 810 | |
| After Ageing | |||
| Tensile Strength (Mpa) | min 14 | 22.3 | |
| Ultimate Elongation (%) | min 500 | 750 | |
| 6. | Powder Content | below 2 mg / glove | |
| 7. | Protein Content | - | below 50 microgram / gram |
3
... ... ...
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-
- The performance data of the glove as shown above 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 < 50mg/gram.
-
- The Biocompetibility Tests consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
+:i
:
We concluded that the Evergreen non-sterile, powder-free Latex Examination Gloves meet:
- ASTM D3578-95 Standard
- FDA pinhole requirements
- FDA minimum powder residual content.
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BY
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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 stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
DEC 1 2 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
YTY Industry (Manjung) SDN. BHD. C/O Leonard Frier, PE President Met Laboratories 914 West Patapsco Avenue Baltimore, Maryland 21230-3432
K974518 Re : Non-Sterile Powder-Free Latex Examination Trade Name: Gloves Colored Requlatory Class: I Product Code: LYY Dated: November 26, 1997 December 2, 1997 Received:
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, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Frier
家源: 行
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 regulation (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
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment I b
of Page
510(k) Number (if known):
Device Name: Evergreen Latex Powder-Free Examination Gloves; Natural, Pink, Blue
Indications For Use:
感到了。 ·
This is a medical glove worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBODD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kim S. Lin
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 510(k) Number
cription Use 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
2
§ 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.