(50 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 D3578-01 and FDA Water leak test.
This document describes the performance data and biocompatibility testing for non-sterile, powder-free, polymer-coated latex examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | ASTM D3578-01 Acceptance Criteria | Reported Device Performance (POWDER FREE LATEX EXAM. GLOVES) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm) | ||
| Size XS | Min 220 | 240 mm minimum for all sizes |
| Size S | Min 220 | 240 mm minimum for all sizes |
| Size M | Min 230 | 240 mm minimum for all sizes |
| Size L | Min 230 | 240 mm minimum for all sizes |
| Size XL | - (No direct criteria stated, but expected to meet general length requirements based on other sizes) | 240 mm minimum for all sizes |
| 3. Palm width (mm) | ||
| Size XS | 70 ± 10 | 73 - 78 |
| Size S | 80 ± 10 | 83 - 88 |
| Size M | 95 ± 10 | 93 - 98 |
| Size L | 111 ± 10 | 103 - 107 |
| Size XL | - (No direct criteria stated) | - (Data not provided in the table, but implied to be within acceptable range for that size) |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | Min 0.10 |
| Palm | Min 0.08 | Min 0.10 |
| 5. Physical Properties | ||
| Before Aging | ||
| Tensile Strength (MPa) | Min 18 | 23 - 25 |
| Ultimate Elongation (%) | Min 650 | 800 - 860 |
| Stress at 500% Elongation | Max 5.5 | 2.1 - 2.7 |
| After Aging | ||
| Tensile Strength (MPa) | Min 14 | 22 - 24 |
| Ultimate Elongation (%) | Min 500 | 800 - 860 |
| 6. Powder Content | Max 2.0 mg/glove | Below 2 mg/glove |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each individual test. The document refers to "Multiple Normal GI AQL = 2.5" for the watertight test, which implies a sampling plan from ASTM D3578-01, but the exact number of gloves tested is not provided.
- Data Provenance: The document is a 510(k) summary submitted by YTY Industry (Manjung) Sdn Bhd, located in Perak Darul Ridzuan, Malaysia. The data is retrospective, as it represents performance testing conducted to demonstrate compliance with standards for the device described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is established by compliance with standardized test methods (ASTM D3578-01 and FDA 1000ML watertight test) and measured physical/chemical properties, not through expert consensus on qualitative data.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving subjective assessment or decision-making that would require an adjudication method like 2+1 or 3+1. The tests involve objective measurements and adherence to specified limits.
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 device is a medical glove, not an AI-assisted diagnostic or imaging tool. There is no human reader or AI component involved in its performance assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device (gloves), not an algorithm or software. Its performance is assessed through laboratory testing against established specifications.
7. The Type of Ground Truth Used
The ground truth used for this device is based on standardized specifications and laboratory measurements. This includes:
- ASTM D3578-01 Standard: A consensus standard for rubber examination gloves, defining various physical properties and performance requirements.
- FDA 1000ML watertight test: A specific requirement from the FDA for glove integrity.
- FDA minimum Powder Residual Content requirements: A regulatory limit for powder content.
- Protein labeling claim: A specific claim regarding the maximum allowable water extractable protein content.
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, as no training set is relevant for this medical device.
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Image /page/0/Picture/0 description: The image shows a black and white graphic of an abstract design. The design features a horizontal curved shape at the top, resembling a crescent or an arch. Below this curved shape, there are several rectangular and square shapes arranged in a symmetrical pattern, giving the impression of a stylized structure or symbol. The overall composition is simple and geometric, with a focus on the contrast between the black shapes and the white background.
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
MAR 0 7 2003
APPENDIX-K
SMDA 510 (K) SUMMARY 1.0 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 Official Correspondence 2. MS. JANNA TUCKER December 20, 2002 Date of Summary Prepared
3.0 Name of Device
Trade Name: NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
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 D3578-01 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 D3578-01 and FDA Water leak test.
6.0 The Intended Use of Glove
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.
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Summary of Performance Data: 7.0
Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.
| TEST | ASTM D3578-01 | POWDER FREE LATEX EXAM.GLOVES |
|---|---|---|
| 1. Watertight (1000ml) | Multiple NormalGI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm)Size XSSMLXL | Min 220Min 220Min 230Min 230- | 240 mm minimum for all sizes |
| 3. Palm width (mm)Size XSSMLXL | 70 ± 1080 ± 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 (%)Stress at 500% ElongationAfter AgingTensile Strength (MPa)Ultimate Elongation (%) | Min 18Min 650Max 5.5Min 14Min 500 | 23 - 25800-8602.1-2.722 - 24800 - 860 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
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- 8.0 The performance data of the glove as shown above meet the ASTM D3578-01 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 ≤ 50 mg/gram.
- 9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion
We concluded that the Multiple Private Labeled Non-Sterile, Powder Free Natural or Colored Latex Examination Gloves with Protein claim of ≤ 50 micrograms per gram meets:
- ASTM D3578-01 Standard -
- FDA pinhole requirements -
- FDA minimum Powder Residual Content. -
- Label Claim of maximum 50 micrograms per gram of glove or less for water ﺴ Extractable Protein.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 7 2003
YTY Industry (MANJUNG) Sdn. Bhd. C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550
Re: K030164
Trade/Device Name: Multiple Private Labeled, Non-Sterile, Powder-Free, Polymer Coated, Natural and/or Violet and Black Color, Latex Examination Gloves with Protein Labeling Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 15, 2003 Received: January 16, 2003
Dear Ms. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Tucker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Puaser
Susan Runner, DDS, MA · Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STAT
YTY INDUSTRY (MANJUNG) SDN BHD Applicant:
510K Number:
- Device Name: MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEN PER GRAM
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.....................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................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be like.
Division of Anesthesiology, General Hospital Infection Control, Dental De
510(k) Number. K030164
§ 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.