(47 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 Polyurethane Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a8 and FDA Water leak test.
The provided document describes the acceptance criteria and performance of "MULTIPLE PRIVATE LABELS, NON-STERILE, POWDER-FREE POLYURETHANE, WHITE COLOR EXAMINATION GLOVES" by YTY Industry (Manjung) Sdn Bhd.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ASTM D6319-00a) | Reported Device Performance (Powder Free Polyurethane Exam Gloves) |
|---|---|---|
| Watertight (1000ml) | Multiple Normal GI AQL = 2.5 | Pass GI AQL = 2.5 |
| Length (mm) | XS: Min 220 | 240 mm minimum for all sizes |
| S: Min 220 | ||
| M: Min 230 | ||
| L: Min 230 | ||
| XL: - | ||
| Palm width (mm) | XS: 70 ± 10 | 73-78 |
| S: 80 ± 10 | 83 - 88 | |
| M: 95 ± 10 | 93-98 | |
| L: 110 ± 10 | 103 - 107 | |
| XL: - | ||
| Thickness (mm) (Single Layer) | Finger: Min 0.05 | Finger: Min 0.13 |
| Palm: Min 0.05 | Palm: Min 0.11 | |
| Physical Properties Before Aging | Tensile Strength (MPa): Min 14 | Tensile Strength (MPa): 16-23 |
| Ultimate Elongation (%): Min 500 | Ultimate Elongation (%): 600-800 | |
| Physical Properties After Aging | Tensile Strength (MPa): Min 14 | Tensile Strength (MPa): 20 - 23 |
| Ultimate Elongation (%): Min 400 | Ultimate Elongation (%): 600-720 | |
| Powder Content | Max 2.0 mg/glove | Below 2 mg/glove |
| Bio-compatibility Test | Pass Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test | The gloves pass the Bio-compatibility Test. |
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. It refers to the ASTM D6319-00a standard and FDA 1000ML watertight test, which would define the sampling plans. The data provenance is from Malaysia, specifically YTY Industry (Manjung) Sdn Bhd. The study appears to be prospective for the device being submitted, as it's testing the performance of their gloves against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The acceptance criteria are based on the ASTM D6319-00a standard and FDA watertest, which are established industry and regulatory standards, not expert consensus for this specific study.
4. Adjudication Method for the Test Set:
This information is not provided. The assessment appears to be based on direct measurement and comparison against defined thresholds in the ASTM standard and FDA test, rather than an adjudication process between human reviewers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on the physical and performance characteristics of a medical glove, not on the interpretation of medical images or data by human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical medical glove and not an algorithm or AI system. The performance tests are direct measurements of the glove's properties
7. The Type of Ground Truth Used:
The ground truth used for performance evaluation is based on established industry standards and regulatory requirements. Specifically:
- ASTM D6319-00a: Standard Specification for Polyurethane Patient Examination Gloves.
- FDA 1000ML watertight test.
- Bio-compatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization).
8. The Sample Size for the Training Set:
This question is not applicable. The device is a physical product (medical glove), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows a black and white symbol that appears to be a stylized representation of an object or emblem. It features a horizontal curved line at the top, resembling an arch or handle, supported by a structure composed of vertical and horizontal lines. The overall design is symmetrical and geometric, giving it a somewhat abstract and symbolic appearance.
(TY INDUSTRY (MANJUNG) SDN. BHD.
(Company No : 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
JUN 17 2003
KO 31384
APPENDIX-H
| 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 | |
| Official Correspondence | 2. MS. JANNA TUCKER | |
| Date of Summary Prepared | May 16, 2003 |
3.0 Name of Device
Trade Name: MULTIPLE PRIVATE LABELS, NON-STERILE, POWDER-FREE POLYURETHANE, WHITE COLOR EXAMINATION GLOVES
Common Name Exam Glove
Classification Name Patient Examination Glove
4.0 Identification of The Legally Marketed Devices
Class I Polyurethane Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"
રું. વ Description of The Device
Class I Polyurethane Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a8 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.
Revised 6-4-03
Page 1 of 3
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APPENDIX H PAGE 2
Summary of Performance Data: 7.0
Performance data of gloves based on ASTM D6319-00a22 and FDA 1000ML watertight test.
| TEST | ASTM D6319-00ae3 | POWDER FREEPOLYURETHANE 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 ± 10110 ± 10- | 73-7883 - 8893-98103 - 107 |
| 4. Thickness (mm)(Single Layer) | ||
| FingerPalm | Min 0.05Min 0.05 | Min 0.13Min 0.11 |
| 5. Physical PropertiesBefore AgingTensile Strength (MPa)Ultimate Elongation (%)After AgingTensile Strength (MPa)Ultimate Elongation (%) | Min 14Min 500Min 14Min 400 | 16-23600-80020 - 23600-720 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
Page 2 of 3
Revised 6-4-03 JT
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APPENDIX H PAGE 3
- The performance data of the glove as shown above meet the ASTM D6319-00a23 8.0 Standard Powder content is below 2 mg per glove.
- 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.
4031284
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10.0 Conclusion
We concluded that the Multiple Private Labeled Non-Sterile, Powder Free Polyurethane White Color Examination Gloves meets: -
ASTM D6319-00a53Standard ー
-
-FDA pinhole requirements
-
Are below the maximum Powder Residual Content as specified in ASTM » D6319-00a83
- We feel this glove is substantially equivalent to the glove approved in K011198.
Page 3 of 3
Revised 6-4-03 JT
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JUN 1 7 2003
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'emarald Sparks. Nevada 89434-9550
Re: K031384
Trade/Device Name: Multiple Private Labeled, Non-Sterile, Powder-Free Polyurethane White Color. Examination Gloves (Intacta* Polyurthane Gloves) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 3, 2003 Received: June 5, 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) 594-4618. 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 yours,
Susan Benon
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
YTY INDUSTRY (MANJUNG) SDN BHD Applicant:
510K Number: 15 031384
Device Name: MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA* POLYURETHANE GLOVES)
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.
| WAN | Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|---|
| (Division Sign-Off)510(k) Number :_ | Division of Anesthesiology, General Hospital,Infection Control, Dental DevicesK621384 | |
| Prescription Use .Per 21 CFR 801.109 | OR | Over-The-Counter |
§ 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.