NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
Device Facts
| Record ID | K143289 |
|---|---|
| Device Name | NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR |
| Applicant | Yty Industry (Manjung) Sdn Bhd |
| Product Code | LZA · General Hospital |
| Decision Date | Aug 18, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended 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.
Device Story
Disposable nitrile examination gloves; worn by healthcare personnel or examiners to provide barrier protection against contamination between patient and examiner. Device is non-sterile and powder-free; available in orange, green, blue, and violet colors. Manufactured from carboxylated butadiene acrylonitrile. Used in clinical or over-the-counter settings. Provides physical barrier; prevents cross-contamination. Benefits patient and examiner by reducing risk of pathogen transmission during examinations.
Clinical Evidence
Bench testing only. Testing included water leak (ASTM D5151-06), dimensions, physical properties (tensile strength, elongation before/after aging), residual powder (ASTM D6124-10), and biocompatibility (ISO 10993-10). All results met ASTM D6319-10 specifications and demonstrated non-irritant/non-sensitizing properties.
Technological Characteristics
Material: Carboxylated butadiene acrylonitrile. Form: Non-sterile, powder-free nitrile examination glove. Standards: ASTM D6319-10 (dimensions, physical properties, barrier), ASTM D5151-06 (water leak), ASTM D6124-10 (residual powder), ISO 10993-10 (biocompatibility). Connectivity: None. Energy source: None. Sterilization: Non-sterile.
Indications for Use
Indicated for use as a disposable medical device worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Regulatory Classification
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.
Predicate Devices
- Non-Sterile On Line Powder Free Nitrile Blue & White Color Examination Glove (K052502)
Related Devices
- K050528 — POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) · Spi Gloves Sdn. Bhd. · May 19, 2005
- K212998 — Powder Free Nitrile Examination Gloves (White, Blue and Black) · Alcatron Gloves Factory · Feb 19, 2022
- K170393 — Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) · Zibo Chengxun Automatic Device Co., Ltd. · May 9, 2017
- K220121 — Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black · Aamedix Glove Sdn Bhd · Apr 11, 2022
- K220232 — Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange · Megine Industries Sdn Bhd · Feb 20, 2022
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2015
YTY INDUSTRY (MANJUNG) SDN. BHD. Ms. Punitha Samy Assistant Manager-DC/RA Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan, Perak Malaysia
Re: K143289
Trade/Device Name: Non-Sterile, Power Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 7, 2015 Received: July 13, 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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known) K143289
K143289
Device Name
Non-Sterile Powder Free Nitrile Examintion Gloves - ORANGE, GREEN, BLUE AND VIOLET COLOR
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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FORM FDA 3881 (8/14)
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PSC Publiching Services (301) 443-6740 FF
Sec 1 IFU Page 1 of 1
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/0 description: The image is a logo for YTY Industry. The logo consists of a square with a blue and white design on the left, followed by the text "YTY INDUSTRY" in blue. The word "INDUSTRY" has a blue line underneath it. The logo is simple and modern, and the blue color gives it a professional look.
## 510 (K) SUMMARY SHEETS
1.0 510 (K) SUMMARY 2.0 Submitter YTY INDUSTRY (MANJUNG) SDN. BHD., Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan, Perak Malaysia 605-6908533 Tel Fax 605-6908533 Name of Contact Person 1. MS. PUNITHA SAMY E-mail:punitha@ytygroup.com.my Date Summary Prepared August 11, 2015 3.0 Name of Device Trade Name: Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color. Common Name: Nitrile Examination Gloves Classification Name: Patient Examination Gloves, Powder Free Device Classification: I Regulation Number: 21 CFR 880.6250 Panel: General Hospital (80) LZA Product Code: 4.0 Identification of The Legally Marketed Devices
Predicate Device Name: Non-Sterile On Line Powder Free Nitrile Blue & White Color Examination Glove]
Predicate 510(K) number: K052502
Manufacturer's Name: YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan
K143289
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#### 5.0 Description of The Device
Non-Sterile, Powder Free Nitrile Examination Gloves – Orange, Green, Blue and Violet Color Color 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 The Intended Use of Glove
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 Nitrile Examination Gloves -Orange, Green, Blue and Violet Color have the below technological characteristic compared to ASTM or Equivalent standards.
| Characteristic | Standards | Performance of<br>Non-Sterile, Powder Free Nitrile<br>Examination Gloves - Orange,<br>Green, Blue and Violet Color |
|---------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 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 irritation<br>ISO 10993-10 (2010) | Non-Irritant |
| | Dermal Sensitization<br>ISO 10993-10 (2010) | Non-sensitizer |
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| Test | FDA<br>1000ml<br>Water Leak<br>Test | YTY Powder Free Nitrile Examination Gloves | | | | Non-Sterile On<br>Line Powder<br>Free Nitrile<br>Blue & White<br>Color<br>Examination<br>Glove<br>Predicate<br>K052502 |
|-------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000ml)<br>ASTM D5151-06 (2011)<br>Test<br>ASTM D6319-10 | Multiple<br>Normal<br>GII<br>AQL = 2.5<br>ASTM<br>D6319-10 | Orange<br>Holes<br>found: 0<br>(Accept 1,<br>Reject 7) | Green<br>Holes<br>found: 0<br>(Accept 1,<br>Reject 7) | Blue<br>Holes found:<br>0<br>(Accept 1,<br>Reject 7) | Violet<br>Holes<br>found: 0<br>(Accept 1,<br>Reject 7) | Holes found: 0<br>(Accept 1,<br>Reject 7) |
| 2. Length (mm)<br>Size M | Min 230 | 242-257 | 240-249 | 240-250 | 240-244 | 240-251 |
| 3. Palm width (mm)<br>Size M | 95 ± 10 | 96-100 | 95-99 | 95-99 | 96-98 | 94-96 |
| 4. Thickness (mm)<br>(Single Layer) | | | | | | |
| Finger<br>Palm | Min 0.05<br>Min 0.05 | 0.11-0.14<br>0.09-0.11 | 0.11-0.14<br>0.07-0.08 | 0.09-0.10<br>0.05-0.06 | 0.09-0.11<br>0.06-0.07 | 0.15-0.19<br>0.12-0.16 |
| 5. Physical Properties | | | | | | |
| Before Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation<br>(%) | Min 14<br>Min 500 | 21.21-<br>29.63<br>540-600 | 24.15-<br>29.21<br>580-620 | 28.46-33.44<br>520-580 | 23.22-<br>29.11<br>520-580 | 26.00-30.00<br>750-800 |
| After Aging<br>Tensile Strength (MPa) | Min 14 | 29.23-<br>33.56 | 28.72-<br>34.84 | 29.76-34.18 | 27.39-<br>30.82 | 25.00-28.00 |
| Ultimate Elongation<br>(%) | Min 400 | 480-520 | 520-540 | 440-520 | 440-500 | 670-730 |
| 6. Residual Powder<br>ASTM-D6124-10<br>(Reapproved 2011) | Max<br>2.0mg/glove | 0.16mg/<br>glove | 0.24mg/<br>glove | 0.20mg/<br>glove | 0.14mg/<br>glove | 0.20mg/ glove |
| 7. Biocompatibility<br>Primary Skin Irritation<br>Dermal Sensitization | ISO 10993-<br>10 (2010)<br>Non-irritant<br>Non-<br>sensitizer | Under the<br>conditions<br>of the<br>study, the<br>device is<br>non-irritant<br>or non-<br>sensitizer | Under the<br>conditions<br>of the<br>study, the<br>device is<br>non-irritant<br>or non-<br>sensitizer | Under the<br>conditions of<br>the study,<br>the device is<br>non-irritant<br>or non-<br>sensitizer | Under the<br>conditions<br>of the<br>study, the<br>device is<br>non-irritant<br>or non-<br>sensitizer | Non-irritant<br>Non-sensitizer |
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| Characteristics | Applicant | | | | Predicate K052502 | Medical Glove<br>Manual (1661) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Blue -<br>Grape | Blue -<br>Apple | Blue -<br>Peppermint | Blue -<br>Vanilla | | |
| Company Name | YTY Industry (Manjung) Sdn Bhd | | | | YTY Industry (Manjung)<br>Sdn Bhd | FDA |
| Product Name | Non-Sterile, Powder Free Scented Blue<br>Nitrile Examination Gloves | | | | Non-Sterile, On Line<br>Powder Free Nitrile<br>Blue & White Color<br>Examination Gloves | Patient Examination<br>Gloves |
| Product Code | LZA | | | | LZA | LZA – (Polymer –<br>other than Vinyl<br>(includes Nitrile,<br>Polyurethane, etc.) |
| Indication for Use | A patient examination gloves is a disposable<br>device intended for medical purpose that is worn<br>on the examiner's hand or fingers to prevent<br>contamination between patient and examiner. | | | | This is a medical glove<br>to be worn on the hand<br>of health care and<br>similar personnel to<br>prevent contamination<br>between health care<br>personnel and the<br>patient. | Powder-Free<br>Examination Gloves<br>A powder-free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner. |
| Device Description | Non-Sterile, Powder Free Scented Blue<br>Nitrile Examination Gloves meets all the<br>current specifications listed under the ASTM<br>Specification D6319-10, Standard Specification<br>for Nitrile Examination Gloves for Medical<br>Application. This device is for over-the counter<br>single use. | | | | Class 1 Nitrile Patient<br>Examination Glove<br>80LZA, powder free that<br>meets all requirements of<br>ASTM Standard D6319-<br>00ae3 and FDA water<br>leak test. | This gloves meet all<br>current specifications<br>listed under ASTM<br>specifications D6319-<br>10 |
| Over the Counter<br>Use | This device is for over-the counter single use. | | | | This device is for over-<br>the counter single use. | Indication for use |
| Single Use | Single Use | | | | Single Use | Labeling |
| Non Sterile or<br>Sterile | Non Sterile | | | | Non Sterile | Sterilization |
| Powder Free | Powder Free | | | | Powder Free | Process & Attribute<br>labeling |
| Compare materials | | | | | | |
| Materials | Carboxylated Butadiene Acrylonitrile | | | | Carboxylated Butadiene<br>Acrylonitrile | LZA - (Polymer -<br>other than Vinyl<br>(includes Nitrile,<br>Polyurethane, etc.) |
# 8.0 Substantial Equivalence Comparison Table with Predicate Device, K052502
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| Characteristics | | | K143289 | Predicate K052502 | Medical Glove | |
|------------------------|-------------------------------------------------------|------------|----------------------------------------|-------------------|----------------------------------------|---------------------|
| | Orange | Geen | Blue<br>YTY Industry (Manjung) Sdn Bhd | YTY Industry | Manual (1661) | |
| Company Name | | | | | | |
| 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 | 21.21- | 24.15- | 28.46- | 23.22- | 26.00-30.00 | gloves |
| before aging (MPa) | 29.63 | 29.21 | 33.44 | 29.11 | | |
| Tensile Strength after | 29.23- | 28.72- | 29.76- | 27.39- | 25.00-28.00 | ASTM D6124-06 |
| aging (MPa) | 33.56 | 34.84 | 34.18 | 30.82 | | (Reapproved |
| Ultimate Elongation | 540-600 | 580-620 | 520-580 | 520-580 | 750-800 | 2011) |
| before aging (%) | | | | | | Residual Powder |
| Ultimate Elongation | 480-520 | 520-540 | 440-520 | 440-500 | 670-730 | |
| after aging (%) | | | | | | ASTM D5151-06 |
| Dimensions Length | 242-257 | 240-249 | 240-250 | 240-244 | 240-251 | (Reapproved |
| (mm) | | | | | | 2011) Detection |
| Dimensions Width | 96-100 | तेर-तेते | तेर-तेत्र | 96-98 | 94-96 | of Holes in |
| (mm) | | | | | | Medical Gloves |
| Thickness Finger | 0.11-0.14 | 0.11-0.14 | 0.09-0.10 | 0.09-0.11 | 0.15-0.19 | |
| (mm) | | | | | | |
| Thickness Cuff (mm) | 0.07-0.09 | 0.06-0.07 | 0.04-0.05 | 0.05-0.06 | 0.09-0.10 | |
| Thickness Palm | 0.09-0.11 | 0.07-0.08 | 0.05-0.06 | 0.06-0.07 | 0.12-0.16 | |
| (mm) | | | | | | |
| 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 | 0.16mg/ | 0.24mg/ | 0.20mg/ | 0.14mg/ | 0.20mg/glove | |
| (mg/glove) | glove | glove | glove | 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 legally | -Powder Free | | | -Powder Free | Chapter 4 - | |
| marketed predicate | -devices color | | | | -devices color: | Labeling |
| | -Scent | | | Clear (Blue) | | |
| | -Patient Examination Glove | | | | -Patient | |
| | -Non sterile | | | | Examination Glove | |
| | -Single Use Only | | | | -Non sterile | |
| | -Manufactured for | | | | -Single Use Only<br>-Manufactured for: | |
| | -Lot<br>-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 Nitrile Examination Gloves – Orange, Green, Blue and Violet Color and the predicate device is substantially equivalent based on intended uses, physical properties, technological characteristics and non-clinical performance. This device is as safe, effective, and performs as well as the predicate device.
