(44 days)
A 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.
Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (<50ug/g) and Polycoating Class I Device, 80LYY
This document describes the acceptance criteria and performance of Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (<50ug/g) and Polycoating (K023577).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-01A62 and FDA 1000ML watertight test) | Reported Device Performance (YTY INDUSTRY POWDER FREE LATEX EXAM. GLOVES) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm) | ||
| XS | Min 220 | 240 mm minimum for all sizes |
| S | Min 220 | 240 mm minimum for all sizes |
| M | Min 230 | 240 mm minimum for all sizes |
| L | Min 230 | 240 mm minimum for all sizes |
| XL | - | 240 mm minimum for all sizes |
| 3. Palm width (mm) | ||
| XS | 70 ± 10 | 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 | Min 0.10 |
| Palm | Min 0.08 | Min 0.10 |
| 5. Physical Properties Before Aging | ||
| Tensile Strength (MPa) | Min 18 | 23 - 27 |
| Ultimate Elongation (%) | Min 650 | 820 - 900 |
| Stress at 500% Elongation | Max 5.5 | 2.9 - 3.8 |
| 5. Physical Properties After Aging | ||
| Tensile Strength (MPa) | Min 14 | 22 - 26 |
| Ultimate Elongation (%) | Min 500 | 780 - 860 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
In addition to the above, the device also met or exceeded the following standards and/or tests:
- ASTM D 5712-99
- ASTM D 3578-01aE2
- ASTM D 6124-01
- ASTM D 5151-99
- ISO 2859
- Bio-Compatibility: Dermal Sensitization
- Bio-Compatibility: Primary Skin Irritation
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific sample size for each test. However, the tests are based on ASTM and FDA standards (ASTM D3578-01 and FDA 1000ML watertight test, ASTM D 5712-99, ASTM D 3578-01aE2, ASTM D 6124-01, ASTM D 5151-99, ISO 2859). These standards typically prescribe specific sampling plans for testing.
The provenance of the data is not specified (e.g., country of origin, retrospective or prospective). The gloves are manufactured by YTY INDUSTRY (MANJUNG) SDN BHD, which is a Malaysian company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical product (examination gloves), and its performance is evaluated against established technical standards (ASTM, FDA, ISO) through quantitative measurements, not by expert consensus on qualitative data.
4. Adjudication method for the test set
This information is not applicable for a physical product testing against quantitative standards. The results are objective measurements against predefined criteria.
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
This information is not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is not a software algorithm.
7. The type of ground truth used
The "ground truth" for this device corresponds to the established acceptance criteria defined by international and national standards for medical gloves (ASTM D3578-01, FDA 1000ML watertight test, ASTM D 5712-99, ASTM D 3578-01aE2, ASTM D 6124-01, ASTM D 5151-99, ISO 2859). Compliance is determined by objective physical and chemical tests against these specified values.
8. The sample size for the training set
This information is not applicable. This is a manufactured product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is a manufactured product, not a machine learning model.
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510(k) SUMMARY
| Submitted For: | YTY INDUSTRY (MANJUNG) SDN BHD |
|---|---|
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for YTY INDUSTRY(MANJUNG) SDN BHDJANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550Phone: 775-342-2612Fax: 775-342-2613E-Mail: Tuckerjan@aol.com |
| Date of Submission: | 21 October 2002 |
| Device Name: | Powder Free, Natural and/or Colored Latex ExamGloves, with Protein labeling (<50ug/g) and PolycoatingClass I Device, 80LYY |
| Proprietary Name: | (Multiple Private Labels) |
| Labels/Labeling: | This device will be marketed to healthcare professionals atDentist and Doctor Offices, Laboratories, Clinics andHospitals through its distributors for the intended use. |
| Intended Use: | A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's handor finger to prevent contamination between patient andexaminer. |
| Substantial Equivalence: | Both in its intended use and/or physicalcharacteristics, this device is equivalent to devicescurrently marketed by U.S. companies. It is SubstantiallyEquilavent to the devices manufactured by SupergradeHealthcare Products SDN BHD, except for color, K014134,and by Shield Gloves Manufacturer (M), except for scent,K000156. |
EXHIBIT Q
Page 90 of 92 (Revised 10-23-02)
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Summary of Performance Data:
Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.
| TEST | ASTM D3578-01A62 | YTY INDUSTRY POWDER FREELATEX 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 | 23 - 27820 - 9002.9-3.822 - 26780 - 860 | |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove | |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
Page 2 of 3
EXHIBIT Q
Page 91 of 92
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510k) Summary page 2.
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 6124-01 ASTM D 5151-99 ISO 2859
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices approved as K014134 and K000156.
EXHIBIT Q
Page 92 of 92
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines connecting them. The profiles are stacked on top of each other, creating a sense of unity and collaboration.
Public Health Service
DEC 0 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
YTY Industry (MANJUNG) Sdn Bhd C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550
Re: K023577
Trade/Device Name: Powder Free, Latex Examination Gloves, Poly Coated Natural and/or Green Color, 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: October 21, 2002 Received: October 23, 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 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. Tücker
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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Ted Ullyot
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
APPLICANT:
YTY INDUSTRY (MANJUNG) SDN. BHD.
510(k) NUMBER:
DEVICE NAME:
POWDER FREE LATEX EXAM GLOVES, POLY COATED, NATURAL AND/OR GREEN COLOR, WITH SAno/o)
A 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.
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clim S. Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023577
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
EXHIBIT B
page 2 of 92 (revised 12-4-02)
§ 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.