(274 days)
Not Found
No
The device is a physical barrier (examination glove) and the summary focuses on material properties and barrier performance, with no mention of AI/ML.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
The device is described as examination gloves, which are used to prevent contamination between patient and examiner. Its function is a barrier, not to provide diagnostic information.
No
The device is a physical examination glove, which is a hardware device, not software. The description focuses on physical properties and performance tests related to the material and barrier function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as 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 describes a barrier device used externally.
- Device Description: The description focuses on the physical properties and barrier function of the gloves.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Testing: The performance studies focus on the physical integrity and barrier properties of the gloves, not on diagnostic performance related to analyzing biological samples.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger (of the examiner)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purpose / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested against ASTM D6319-10 for Dimension, Physical Properties, Freedom from holes, and Powder-free. It meets all these standards.
Biocompatibility testing (Primary skin irritation and Dermal Sensitization) was performed under ISO 10993-10 (2010), and the device was found to be Non-Irritant and Non-sensitizer.
Specific test results for the Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color (K143289) compared to the predicate K052502 include:
- Watertight (1000ml) ASTM D5151-06 (2011) Test / ASTM D6319-10: Holes found: 0 for all colors (Orange, Green, Blue, Violet), matching the predicate.
- Length (mm) Size M: Orange 242-257, Green 240-249, Blue 240-250, Violet 240-244. Predicate 240-251.
- Palm width (mm) Size M: Orange 96-100, Green 95-99, Blue 95-99, Violet 96-98. Predicate 94-96.
- Thickness (mm) (Single Layer) Finger: Orange 0.11-0.14, Green 0.11-0.14, Blue 0.09-0.10, Violet 0.09-0.11. Predicate 0.15-0.19.
- Thickness (mm) (Single Layer) Palm: Orange 0.09-0.11, Green 0.07-0.08, Blue 0.05-0.06, Violet 0.06-0.07. Predicate 0.12-0.16.
- Physical Properties Before Aging Tensile Strength (MPa): Orange 21.21-29.63, Green 24.15-29.21, Blue 28.46-33.44, Violet 23.22-29.11. Predicate 26.00-30.00.
- Physical Properties Before Aging Ultimate Elongation (%): Orange 540-600, Green 580-620, Blue 520-580, Violet 520-580. Predicate 750-800.
- Physical Properties After Aging Tensile Strength (MPa): Orange 29.23-33.56, Green 28.72-34.84, Blue 29.76-34.18, Violet 27.39-30.82. Predicate 25.00-28.00.
- Physical Properties After Aging Ultimate Elongation (%): Orange 480-520, Green 520-540, Blue 440-520, Violet 440-500. Predicate 670-730.
- Residual Powder ASTM-D6124-10 (Reapproved 2011) mg/glove: Orange 0.16, Green 0.24, Blue 0.20, Violet 0.14. Predicate 0.20.
- Biocompatibility Primary Skin Irritation / Dermal Sensitization: Non-irritant / Non-sensitizer for all colors, matching the predicate.
The device meets the specified AQL of 2.5 for barrier properties (Result: 0 holes found).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (8/14)
Page 1 of 1
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.
3
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
4
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
Non-Sterile, Powder Free Nitrile
Examination Gloves - Orange,
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
ISO 10993-10 (2010) | Non-Irritant |
| | Dermal Sensitization
ISO 10993-10 (2010) | Non-sensitizer |
5
| Test | FDA
1000ml
Water Leak
Test | YTY Powder Free Nitrile Examination Gloves | | | | Non-Sterile On
Line Powder
Free Nitrile
Blue & White
Color
Examination
Glove
Predicate
K052502 |
|-------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000ml)
ASTM D5151-06 (2011)
Test
ASTM D6319-10 | Multiple
Normal
GII
AQL = 2.5
ASTM
D6319-10 | Orange
Holes
found: 0
(Accept 1,
Reject 7) | Green
Holes
found: 0
(Accept 1,
Reject 7) | Blue
Holes found:
0
(Accept 1,
Reject 7) | Violet
Holes
found: 0
(Accept 1,
Reject 7) | Holes found: 0
(Accept 1,
Reject 7) |
| 2. Length (mm)
Size M | Min 230 | 242-257 | 240-249 | 240-250 | 240-244 | 240-251 |
| 3. Palm width (mm)
Size M | 95 ± 10 | 96-100 | 95-99 | 95-99 | 96-98 | 94-96 |
| 4. Thickness (mm)
(Single Layer) | | | | | | |
| Finger
Palm | Min 0.05
Min 0.05 | 0.11-0.14
0.09-0.11 | 0.11-0.14
0.07-0.08 | 0.09-0.10
0.05-0.06 | 0.09-0.11
0.06-0.07 | 0.15-0.19
0.12-0.16 |
| 5. Physical Properties | | | | | | |
| Before Aging
Tensile Strength (MPa)
Ultimate Elongation
(%) | Min 14
Min 500 | 21.21-
29.63
540-600 | 24.15-
29.21
580-620 | 28.46-33.44
520-580 | 23.22-
29.11
520-580 | 26.00-30.00
750-800 |
| After Aging
Tensile Strength (MPa) | Min 14 | 29.23-
33.56 | 28.72-
34.84 | 29.76-34.18 | 27.39-
30.82 | 25.00-28.00 |
| Ultimate Elongation
(%) | Min 400 | 480-520 | 520-540 | 440-520 | 440-500 | 670-730 |
| 6. Residual Powder
ASTM-D6124-10
(Reapproved 2011) | Max
2.0mg/glove | 0.16mg/
glove | 0.24mg/
glove | 0.20mg/
glove | 0.14mg/
glove | 0.20mg/ glove |
| 7. Biocompatibility
Primary Skin Irritation
Dermal Sensitization | ISO 10993-
10 (2010)
Non-irritant
Non-
sensitizer | Under the
conditions
of the
study, the
device is
non-irritant
or non-
sensitizer | Under the
conditions
of the
study, the
device is
non-irritant
or non-
sensitizer | Under the
conditions of
the study,
the device is
non-irritant
or non-
sensitizer | Under the
conditions
of the
study, the
device is
non-irritant
or non-
sensitizer | Non-irritant
Non-sensitizer |
Sec 1 Sum Page 3 of 6
6
| Characteristics | Applicant | | | | Predicate K052502 | Medical Glove
Manual (1661) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Blue -
Grape | Blue -
Apple | Blue -
Peppermint | Blue -
Vanilla | | |
| Company Name | YTY Industry (Manjung) Sdn Bhd | | | | YTY Industry (Manjung)
Sdn Bhd | FDA |
| 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 |
| Product Code | LZA | | | | LZA | LZA – (Polymer –
other than Vinyl
(includes Nitrile,
Polyurethane, etc.) |
| 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 Gloves
A 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. |
| 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
80LZA, powder free that
meets all requirements of
ASTM Standard D6319-
00ae3 and FDA water
leak test. | This gloves meet all
current specifications
listed under ASTM
specifications D6319-
10 |
| 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 |
| Single Use | Single Use | | | | Single Use | Labeling |
| Non Sterile or
Sterile | Non Sterile | | | | Non Sterile | Sterilization |
| Powder Free | Powder Free | | | | Powder Free | Process & Attribute
labeling |
| Compare materials | | | | | | |
| Materials | Carboxylated Butadiene Acrylonitrile | | | | Carboxylated Butadiene
Acrylonitrile | LZA - (Polymer -
other than Vinyl
(includes Nitrile,
Polyurethane, etc.) |
8.0 Substantial Equivalence Comparison Table with Predicate Device, K052502
7
| Characteristics | K143289 | Predicate K052502 | Medical Glove | |||
|---|---|---|---|---|---|---|
| Orange | Geen | Blue | ||||
| 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 | |||||
| -Manufactured for: | ||||||
| -Lot | ||||||
| -Intended use | -Lot | |||||
8
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.