(112 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, and Vanilla meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
Here's a summary of the acceptance criteria and study information for the "Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance (Grape, Apple, Peppermint, Vanilla) |
|---|---|---|
| Dimension | ASTM D6319-10 (Min 230mm length for Size M) | Meets (240-251mm length for Size M in all scented variations) |
| Physical Properties | ASTM D6319-10 (Before Aging: Min 14 MPa Tensile Strength, Min 500% Elongation; After Aging: Min 14 MPa Tensile Strength, Min 400% Elongation) | Meets (Reported ranges consistently exceed minimums for all scented variations) |
| Freedom from holes | ASTM D6319-10 (AQL = 2.5) | Meets (0 holes found in samples for all scented variations) |
| Powder-free | ASTM D6319-10 (Max 2.0 mg/glove residual powder) | Meets (0.10 - 0.16 mg/glove residual powder for all scented variations) |
| Biocompatibility | ISO 10993-10 (Non-irritant, Non-sensitizer) | Meets (Device is non-irritant and non-sensitizer under study conditions) |
| Watertight (1000ml) | ASTM D5151-06 (2011) / ASTM D6319-10 (AQL = 2.5) | Meets (0 holes found in samples for all scented variations) |
| Length (Size M) | Min 230 mm (ASTM D6319-10) | 240-251 mm (all scented variations) |
| Palm Width (Size M) | 95 +/- 10 mm (ASTM D6319-10) | Ranges like "93-96" or "94-96" (all scented variations) |
| Thickness (Single Layer) | Min 0.05 mm (Finger, Palm) (ASTM D6319-10) | Finger: 0.10-0.14 mm; Palm: 0.07-0.09 mm (all scented variations) |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the exact sample size used for each specific test (e.g., number of gloves tested for watertightness, physical properties, etc.). It refers to meeting general ASTM standards which typically define sample sizes for such tests.
- The data provenance is Malaysia, as the manufacturing company (YTY Industry (Manjung) SDN. BHD.) is based there.
- The study appears to be prospective as it's a submission for product clearance, implying these tests were conducted on the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the ground truth is established through adherence to standardized international and FDA-recognized test methods and specifications (ASTM D6319-10, ISO 10993-10, ASTM D5151-06, ASTM D6124-10). These standards define objective, measurable criteria, and therefore do not require expert consensus for interpretation in the same way, for example, diagnostic image analysis might.
4. Adjudication Method for the Test Set:
- None in the typical sense of expert adjudication. The tests (e.g., water leak, tensile strength, irritation) produce objective, quantitative results that are compared directly against the predefined acceptance criteria from the relevant ASTM and ISO standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation is a key component, and the AI's effect on human performance is being evaluated. This submission is for examination gloves, which do not involve human interpretation of AI output.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The performance evaluation is based on the physical and chemical properties of the gloves themselves.
7. Type of Ground Truth Used:
- The ground truth is based on objective, measurable criteria defined by established international and national standards for medical gloves. Specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151-06 (2011): Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-10 (2011): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization (for biocompatibility).
8. Sample Size for the Training Set:
- Not applicable. This is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of gloves is subject to Quality Management Systems (e.g., 21 CFR Part 820) which involve process control and quality assurance, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, for the same reasons as point 8.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
YTY Industry (Manjung) SDN. BHD. Ms. Punitha Samy, Assistant Manager DC/RA Lot 1422-1424, Batu 10 Lekir Sitiawan, Perak Darul Ridzuan Malaysia 32020
Re: K143055
Trade/Device Name: Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves -Grape, Apple, Peppermint, Vanilla Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 2, 2015 Received: January 8, 2015
Dear Ms. Samy:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Samy
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D. Teiashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K143055
Device Name
NON-STERILE, POWDER FREE SCENTED BLUE NITRILE EXAMINATION GLOVES - GRAPE, APPLE, PEPPERMINT, VANILLA
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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YTY INDUSTRY (MANJUNG) SDN BHD
(Company No. 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia Tel: 05-679 2288 (Hunting Line), 679 2443 & 679 2445 Fax: 05-6791188
| 510 (K) SUMMARY SHEETS | |
|---|---|
| 1.0 |
| 510 (K) SUMMARY | ||
|---|---|---|
| 2.0 | Submitter | YTY INDUSTRY (MANJUNG) SDN. BHD.,Lot 1422-1424, Batu 10 Lekir32020 Sitiawan, PerakMalaysia |
| Tel | 605-6792288 | |
| Fax | 605-6791188 | |
| Name of Contact Person | 1. MS. PUNITHA SAMYE-mail: punitha@ytygroup.com.my | |
| Date Summary Prepared | February 12, 2015 |
| 3.0 | Name of Device | |
|---|---|---|
| Trade Name: | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves – Grape, Apple, Peppermint, Vanilla | |
| Common Name: | Nitrile Examination Gloves | |
| Classification Name: | Patient examination glove | |
| Device Classification: | I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Panel: | General Hospital (80) | |
| Product Code: | LZA |
| 4.0 | Identification of The Legally Marketed Devices | |
|---|---|---|
| Predicate Device Name: | Non-Sterile, On Line Powder Free Nitrile Blue & White Color Examination Gloves | |
| Predicate 510(K) number: | K052502. |
Manufacturer's Name: YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan
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5.0 Description of The Device
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, and Vanilla meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This device is for over-the counter use.
7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-sterile, Powder Free Scented Blue Nitrile Examination Gloves have the below technological characteristic compared to ASTM or Equivalent standards.
| Characteristic | Standards | Performance ofNon-Sterile, Powder FreeScented Blue NitrileExamination Gloves |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from holes | ASTM D6319-10 | Meets |
| Powder-free | ASTM D6319-10 | Meets |
| Bio-compatibility | Primary skin irritationISO 10993-10 | Non-Irritant |
| Dermal SensitizationISO 10993-10 | Non-sensitizer |
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| Test | T OF THE FINAL OF COLLED OF CRUPA ART THE FOR THE T PLATE T PATT TAGALATE HOME TEMP ASSEFDA1000mlWater LeakTest | YTY Powder Free Nitrile Examination Gloves | Non-Sterile OnLine PowderFree NitrileBlue & WhiteColorExaminationGlove | Characteristics | Applicant | Predicate K052502 | Medical Glove Manual (1661) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Watertight (1000ml) | MultipleNormal | Blue-Grape | Blue-Apple | Blue-Peppermint | Blue-Vanilla | PredicateK052502 | Blue - Grape | Blue - Apple | Blue - Peppermint | Blue - Vanilla | |||
| ASTM D5151-06 (2011)TestASTM D6319-10 | GIIAQL = 2.5ASTMD6319-10 | Holesfound: 0(Accept 1,Reject 7) | Holesfound: 0(Accept 1,Reject 7) | Holes found:0(Accept 1,Reject 7) | Holesfound: 0(Accept 1,Reject 7) | Holes found: 0(Accept 1,Reject 7) | Company Name | YTY Industry (Manjung) Sdn Bhd | YTY Industry (Manjung) Sdn Bhd | FDA | |||
| 2. Length (mm)SizeM | Min 230 | 240-243 | 240-249 | 240-249 | 240-251 | 240-251 | Product Name | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves | Non-Sterile, On Line Powder Free Nitrile Blue & White Color Examination Gloves | Patient Examination Gloves | |||
| 3. Palm width (mm)SizeM | 95 + 10 | તેર-તેવે | તેર-તેત્ર | તેર-તેત્ર | 94-96 | 94-96 | Product Code | LZA | LZA | LZA - (Polymer - other than Vinyl (includes Nitrile, Polyurethane, etc.) | |||
| 4. Thickness (mm)(Single Layer) | Indication for Use | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. | 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. | Powder-Free Examination GlovesA powder-free 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. | |||||||||
| FingerPalm | Min 0.05Min 0.05 | 0.10-0.140.07-0.08 | 0.10-0.140.07-0.08 | 0.11-0.140.07-0.08 | 0.11-0.140.08-0.09 | 015-0.190.12-0.16 | Device Description | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. | Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all requirements of ASTM Standard D6319-00a3 and FDA water leak test. | This gloves meet all current specifications listed under ASTM specifications D6319-10 | |||
| 5. Physical Properties | Over the Counter Use | This device is for over-the counter single use. | This device is for over-the counter single use. | Indication for use | |||||||||
| Before AgingTensile Strength (MPa)Ultimate Elongation(%) | Min 14Min 500 | 25.70-29.83520-580 | 25.99-28.39520-580 | 24.11-28.98520-580 | 24.54-30.14540-580 | 26.00-30.00750-800 | Use | Single Use | Single Use | Directions for use | |||
| After AgingTensile Strength (MPa) | Min 14 | 27.76-31.67 | 28.39-31.61 | 26.53-30.77 | 29.25-32.35 | 25.00-28.00 | Non Sterile or Sterile | Non Sterile | Non Sterile | Sterilization | |||
| Ultimate Elongation(%) | Min 400 | 460-500 | 460-500 | 440-500 | 460-480 | 670-730 | Powder Free | Powder Free | Powder Free | Process & Attribute labeling | |||
| 6. Residual PowderASTM-D6124-10(Reapproved 2011) | Max2.0mg/glove | 0.16mg/glove | 0.10mg/glove | 0.12mg/glove | 0.12mg/glove | 0.20%/ glove | Compare materials | ||||||
| 7. BiocompatibilityPrimary Skin IrritationDermal Sensitization | ISO 10993-10Non-irritantNon-sensitizer | Under theconditionsof thestudy, thedevice isnon-irritantor non-sensitizer | Under theconditionsof thestudy, thedevice isnon-irritantor non-sensitizer | Under theconditions ofthe study,the device isnon-irritantor non-sensitizer | Under theconditionsof thestudy, thedevice isnon-irritantor non-sensitizer | Non-irritantNon-sensitizer | Materials | Carboxylated Butadiene Acrylonitrile | Carboxylated Butadiene Acrylonitrile | LZA - (Polymer - other than Vinyl (includes Nitrile, Polyurethane, etc.) |
Performance data of gloves based on ASTM D6319-10 and FDA 1000ML water leak test.
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8.0 Substantial Equivalence Comparison Table with Predicate Device, K052502
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| K143055 | ||||||||
|---|---|---|---|---|---|---|---|---|
| K143055 | Medical Glove | |||||||
| Characteristics | Blue -Apple | Blue -Grape | Blue -Peppermint | Blue - Vanilla | Predicate K052502 | Manual (1661) | ||
| Company Name | YTY Industry (Manjung) Sdn Bhd | YTY Industry(Manjung) Sdn Bhd | ||||||
| Specifications and | Dimension: Finger & Palm Thickness min: 0.05mm | Current gloves | ||||||
| Performance | Physical Properties: Min 14MPa Before and After Aging | meet ASTM | ||||||
| Barrier: AQL 2.5 | D6319-10 Nitrile | |||||||
| Tensile Strength | 25.70- | 25.99- | 24.11- | 24.54- | 26.00-30.00 | gloves | ||
| before aging (MPa) | 29.83 | 29.83 | 28.98 | 30.15 | ||||
| Tensile Strength after | 27.76- | 28.39- | 26.53- | 29.25- | 25.00-28.00 | ASTM D6124-06 | ||
| aging (MPa) | 31.67 | 31.61 | 30.77 | 32.35 | (Reapproved | |||
| Ultimate Elongation | 520-580 | 520-580 | 520-580 | 540-580 | 750-800 | 2011) | ||
| before aging (%) | Residual Powder | |||||||
| Ultimate Elongation | 460-500 | 460-500 | 440-500 | 460-480 | 670-730 | |||
| after aging (%) | ASTM D5151-06 | |||||||
| Dimensions Length | 240-243 | 240-249 | 240-249 | 240-251 | 240-251 | (Reapproved | ||
| (mm) | 2011) Detectionof Holes in | |||||||
| Dimensions Width | तेर-तेत्र | d5-99 | d3-dd | 96-99 | 94-96 | Medical Gloves | ||
| (mm) | ||||||||
| Thickness Finger | 0.10-0.14 | 0.11-0.14 | 0.11-0.14 | 0.11-0.14 | 0.15-0.19 | |||
| (mm) | ||||||||
| Thickness Cuff (mm) | 0.06 | 0.06 | 0.06-0.07 | 0.07-0.08 | 0.09-0.10 | |||
| Thickness Palm(mm) | 0.07-0.08 | 0.07-0.08 | 0.07-0.08 | 0.08-0.09 | 0.12-0.16 | |||
| AQL | AQL 2.5 | AQL 2.5 | AQL 2.5 | AQL 2.5 | AQL 2.5 | |||
| Result: 0 | Result: 0 | Result: 0 | Result: 0 | Result: 0 | ||||
| Residual Powder | 0.16 | 0.10 | 0.16 | 0.12 | 0.20 | |||
| (mg/glove) | ||||||||
| Size | M | M | M | M | M | |||
| Bio-compatibility | Under the | Under the | Under the | Under the | Non-irritant | ISO 10993-10 | ||
| condition | condition | condition | condition | Non-sensitizer | Test for Irritation | |||
| of the | of the | of the | of the study | and Skin | ||||
| study the | study the | study the | the device | Sensitization | ||||
| device is | device is | device is | is non- | |||||
| non- | non- | non- | irritant and | |||||
| irritant | irritant | irritant | non- | |||||
| and non- | and non- | and non- | sensitizer | |||||
| sensitizer | sensitizer | sensitizer | ||||||
| Labeling for legallymarketed predicate | -Powder Free-devices color | -Powder Free-devices color: | Chapter 4 -Labeling | |||||
| -Scent | Clear (Blue) | |||||||
| -Patient Examination Glove | -Patient | |||||||
| -Non sterile | Examination Glove | |||||||
| -Single Use Only | -Non sterile | |||||||
| -Manufactured for | -Single Use Only | |||||||
| -Lot | -Manufactured for: | |||||||
| -Intended use | -Lot | |||||||
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9.0 Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the device, Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves – Grape, Apple, Peppermint and Vanilla and the predicate device is substantially equivalent based on intended uses, physical properties, technological characteristics and non-clinical performance.
Sec 1 Sum Page 6 of 6
§ 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.