(35 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 I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-01 and FDA Water Leak Test.
The provided documentation describes the acceptance criteria and performance data for Non-Sterile Powdered Natural or Colored Latex Examination Gloves. This is a medical device, and the study described is a performance verification test against established industry standards. It is not an AI/ML device, therefore, many of the requested fields are not applicable.
Here's the breakdown of the information as it applies:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3578-01) | Reported Device Performance (POWDERED LATEX EXAM. GLOVES) |
|---|---|---|
| Watertight (1000ml) | Multiple Normal GI, AQL = 2.5 | Pass GI, AQL = 2.5 |
| Length (mm) | Min 220 (XS, S), Min 230 (M, L), - (XL) | 240 mm minimum for all sizes |
| Palm Width (mm) | 70 ± 10 (XS), 80 ± 10 (S), 95 ± 10 (M), 111 ± 10 (L), - (XL) | 73 - 78 (XS), 83 - 88 (S), 93 - 98 (M), 103 - 107 (L) |
| Thickness (mm) (Single Layer) | Min 0.08 (Finger), Min 0.08 (Palm) | Min 0.10 (Finger), Min 0.10 (Palm) |
| Physical Properties - Before Aging | ||
| Tensile Strength (MPa) | Min 18 | 26 - 30 |
| Ultimate Elongation (%) | Min 650 | 820 - 940 |
| Stress at 500% Elongation | Max 5.5 | 2.0 - 3.3 |
| Physical Properties - After Aging | ||
| Tensile Strength (MPa) | Min 14 | 24 - 30 |
| Ultimate Elongation (%) | Min 500 | 840 - 920 |
| Powder Content | 10mg per square decimetre max | Below 10 mg per square decimetre |
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 only references the ASTM D3578-01 standard, which would define the sampling plans. The data provenance is derived from internal testing conducted by YTY Industry (Manjung) Sdn Bhd in Malaysia, referencing internationally recognized standards. This is likely retrospective testing of manufactured batches to ensure compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This study involves physical and chemical property testing of a manufactured product against established engineering standards (ASTM D3578-01 and FDA Water Leak Test), not clinical interpretation requiring expert consensus. The "ground truth" is defined by the objective measurement parameters within these standards.
4. Adjudication Method for the Test Set
Not applicable. This type of testing does not involve subjective adjudication by human experts in the way clinical diagnostic studies do. The results are based on objective measurements and pass/fail criteria as defined by the 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 document describes a medical device (examination gloves) that is not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective, measurable physical and chemical properties defined by established international standards:
- ASTM D3578-01: Standard for Latex Examination Gloves.
- FDA Water Leak Test: Specific for watertightness of medical gloves (1000ml test).
- Other referenced standards like ASTM D 5712-99, ASTM D 5151-99, ASTM D 6124-01, and ISO 2859 (likely for sampling procedures).
8. The Sample Size for the Training Set
Not applicable. This is a physical product undergoing performance verification, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As described above, there is no AI/ML model or corresponding training set.
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YTY INDUSTRY (MANJUNG) SDN. BHD.
Company No : 380830-P)
mpany No : 000304 7
1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysi�EB 0 3 2003 Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
APPENDIX I.
| 1.0 | 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 | |
| Official Correspondence | 1. JANNA TUCKER | |
| Date of Summary Prepared | November 30, 2002 |
3.0 Name of Device
| Trade Name | Non-Sterile Powdered Natural or Colored Latex Examination Gloves (Multiple Private Labels) |
|---|---|
| Common Name | Exam Glove |
| Classification Name | Patient Examination Glove |
4.0 Identification 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 D3578-01.
Description of The Device 5.0
Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirement 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.
Page 1 of 3
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7.0 Summary of Performance Data:
| TEST | ASTM D3578-01 | POWDERED LATEX EXAM.GLOVES |
|---|---|---|
| 1. Watertight (1000ml) | Multiple NormalGIAQL = 2.5 | Pass GIAQL = 2.5 |
| 2. Length (mm)SizeXSSMLXL | Min 220Min 220Min 230Min 230- | 240 mm minimum for all sizes |
| 3. Palm width (mm)SizeXSSMLXL | 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 | 26 - 30820 - 9402.0-3.324 - 30840 - 920 |
| 6. Powder Content | 10mg per square decimetre max | Below 10 mg per square decimetre |
Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.
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510k) Summary page 3.
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests: :
ASTM D 5712-99 ASTM D 3578-01aE2 ASTM D 5151-99 ASTM D 6124-01 ISO 2859
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices approved as K943807, K974191 and K023590.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 3 2003
YTY Industry (Manjung) Sdn. Bhd. C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'emerald Sparkes, Nevada 89434-9550
Re: K024355
Trade/Device Name: Non-Sterile, Powdered, Natural or Colored Latex Examination Gloves, Violet & Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 23, 2002 Received: December 30, 2002
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 vour 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) 594-4618. 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 vours.
Susan Kunn
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 STATEMENT
.
:
Applicant: YTY INDUSTRY (MANJUNG) SDN BHD
Kost 35.5 510K NUMBER:
Non-Sterile, Powdered, Natural or Colored Latex Examination Gloves Device Name: (Violet & Green Color) (Multiple Private Label)
Indication 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 ... ... ... .................
・
Qhin S. Lin
nesthesiology. General H
510(k) Number: K 024355
§ 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.