(112 days)
Not Found
No
The device description and performance data focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No.
The device description clearly states it is for preventing contamination between patient and examiner, which is a barrier function, not a therapeutic one.
No
The device is a medical examination glove, which is a barrier device intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device is a physical product (gloves) and the summary describes physical properties and performance testing related to those physical properties, not software functionality.
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 during physical examination, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the physical properties and barrier function of the gloves, and testing against standards like ASTM D6319-10 and FDA water leak tests. These are tests related to the physical integrity and performance of a barrier, not diagnostic tests performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
The device is a medical device, specifically a Class I or Class II medical glove, but it does not fit the definition of 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Performance data of gloves based on ASTM D6319-10 and FDA 1000ML water leak test.
Watertight (1000ml) ASTM D5151-06 (2011) Test ASTM D6319-10, GII AQL = 2.5 ASTM D6319-10. Holes found: 0 (Accept 1, Reject 7) for all scented variations.
Length (mm) Size M: 240-243 (Grape), 240-249 (Apple, Peppermint), 240-251 (Vanilla). Minimum 230 required.
Palm width (mm) Size M: 93-94 (Grape, Apple, Peppermint), 94-96 (Vanilla). Requirement 95 + 10.
Thickness (mm) (Single Layer) Finger: 0.10-0.14 (Grape, Apple, Peppermint), 0.11-0.14 (Vanilla). Minimum 0.05 required.
Thickness (mm) (Single Layer) Palm: 0.07-0.08 (Grape, Apple, Peppermint), 0.08-0.09 (Vanilla). Minimum 0.05 required.
Physical Properties Before Aging Tensile Strength (MPa): 25.70-29.83 (Grape), 25.99-28.39 (Apple), 24.11-28.98 (Peppermint), 24.54-30.14 (Vanilla). Minimum 14 required.
Physical Properties Before Aging Ultimate Elongation (%): 520-580 (Grape, Apple, Peppermint), 540-580 (Vanilla). Minimum 500 required.
Physical Properties After Aging Tensile Strength (MPa): 27.76-31.67 (Grape), 28.39-31.61 (Apple), 26.53-30.77 (Peppermint), 29.25-32.35 (Vanilla). Minimum 14 required.
Physical Properties After Aging Ultimate Elongation (%): 460-500 (Grape, Apple), 440-500 (Peppermint), 460-480 (Vanilla). Minimum 400 required.
Residual Powder ASTM-D6124-10 (Reapproved 2011): 0.16mg/glove (Grape), 0.10mg/glove (Apple), 0.12mg/glove (Peppermint), 0.12mg/glove (Vanilla). Maximum 2.0mg/glove required.
Biocompatibility Primary Skin Irritation ISO 10993-10: Non-irritant for all scented variations.
Biocompatibility Dermal Sensitization ISO 10993-10: Non-sensitizer for all scented variations.
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 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.
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 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a green symbol with a gold outline. The symbol appears to be abstract, with a horizontal curved line at the top and three vertical rectangular shapes below it. The two outer rectangular shapes have additional horizontal extensions on their outer sides, creating a stylized, symmetrical design.
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 Lekir | ||
| 32020 Sitiawan, Perak | ||
| Malaysia | ||
| Tel | 605-6792288 | |
| Fax | 605-6791188 | |
| Name of Contact Person | 1. MS. PUNITHA SAMY | |
| E-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
4
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 of
Non-Sterile, Powder Free
Scented Blue Nitrile
Examination 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 irritation
ISO 10993-10 | Non-Irritant |
| | Dermal Sensitization
ISO 10993-10 | Non-sensitizer |
5
| Test | T OF THE FINAL OF COLLED OF CRUPA ART THE FOR THE T PLATE T PATT TAGALATE HOME TEMP ASSE
FDA
1000ml
Water Leak
Test | YTY Powder Free Nitrile Examination Gloves | Non-Sterile On
Line Powder
Free Nitrile
Blue & White
Color
Examination
Glove | Characteristics | Applicant | | | | Predicate K052502 | Medical Glove Manual (1661) | | | |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000ml) | Multiple
Normal | Blue-
Grape | Blue-
Apple | Blue-
Peppermint | Blue-
Vanilla | Predicate
K052502 | | Blue - Grape | Blue - Apple | Blue - Peppermint | Blue - Vanilla | | |
| ASTM D5151-06 (2011)
Test
ASTM D6319-10 | GII
AQL = 2.5
ASTM
D6319-10 | Holes
found: 0
(Accept 1,
Reject 7) | Holes
found: 0
(Accept 1,
Reject 7) | Holes found:
0
(Accept 1,
Reject 7) | Holes
found: 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)
Size
M | 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)
Size
M | 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 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. |
| Finger
Palm | Min 0.05
Min 0.05 | 0.10-0.14
0.07-0.08 | 0.10-0.14
0.07-0.08 | 0.11-0.14
0.07-0.08 | 0.11-0.14
0.08-0.09 | 015-0.19
0.12-0.16 | 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 Aging
Tensile Strength (MPa)
Ultimate Elongation
(%) | Min 14
Min 500 | 25.70-
29.83
520-580 | 25.99-
28.39
520-580 | 24.11-28.98
520-580 | 24.54-
30.14
540-580 | 26.00-30.00
750-800 | Use | Single Use | | | | Single Use | Directions for use |
| After Aging
Tensile 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 Powder
ASTM-D6124-10
(Reapproved 2011) | Max
2.0mg/glove | 0.16mg/
glove | 0.10mg/
glove | 0.12mg/
glove | 0.12mg/
glove | 0.20%/ glove | Compare materials | | | | | | |
| 7. Biocompatibility
Primary Skin Irritation
Dermal Sensitization | ISO 10993-
10
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 | 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.
6
8.0 Substantial Equivalence Comparison Table with Predicate Device, K052502
7
| 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) Detection | |||||||
| of 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 legally | ||||||||
| marketed 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 | |||||||
8
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