(86 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is described as examination gloves used to prevent contamination, not to treat or diagnose a disease or condition.
No
The device, Blue Nitrile Examination Gloves, is described as a disposable device worn on the examiner's hand to prevent contamination. Its purpose is protective and preventive, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (gloves) made from acrylonitrile-butadiene copolymer dispersion, and the performance studies focus on physical properties and biocompatibility. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the material, color, powder status, and sizes of examination gloves. This aligns with personal protective equipment, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures. This device does not fit that description.
N/A
Intended Use / Indications for Use
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the length of the gloves | Min 230 mm for all sizes | X-Small:- 245 mm Small:- 245 mm Medium:- 246mm Large:- 248 mm X-Large:- 248 mm |
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the width of the gloves | X-small:- 70+/-10 mm Small:- 80+/-10 mm Medium:- 95+/-10mm Large:- 110+/-10 mm X-Large:- 120+/-10 mm | X-small:- 76 mm Small:- 84 mm Medium:- 94 mm Large:- 105 mm X-Large:- 115 mm |
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the thickness of the gloves | Palm 0.05 mm min Finger 0.05 mm min for all sizes | Size: X-Small, Small, Medium, Large, X-Large / Palm: 0.09mm for all sizes / Finger: 0.15mm for all sizes |
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties- Tensile strength | Before Ageing Tensile Strength 14Mpa Min for all sizes After Ageing Tensile Strength 14Mpa Min for all sizes | Before ageing: 22.76Mpa (X-Small) - 24.59Mpa (X-Large) After ageing: 20.50Mpa (X-Small) - 22.05Mpa (X-Large) |
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties- Ultimate Elongation | Before Ageing Ultimate Elongation 500% Min for all sizes After Ageing Ultimate Elongation 400% Min for all sizes | Before ageing: 884% (X-Small) - 892% (X-Large) After ageing: 867% (X-Small) - 875% (X-Large) |
| ASTM D5151-2019 Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | X-small 0.16mg/glove Small 0.16mg/glove Medium 0.16 mg/glove Large 0.16 mg/glove X-Large 0.16 mg/glove |
| ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done for irritation. | To determine the potential of the material under test to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done Skin sensitization. | To determine the skin sensitization potential of the material both in terms of induction and elicitation in Guinea Pig. | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| ISO 10993-5:2009 biological evaluation of medical devices - part 5, tests for in vitro cytotoxicity. | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method. | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. |
| ISO 10993-11:2017 biological evaluation of medical devices - part 11, tests for systemic toxicity. | To determine the acute systemic toxicity potential of the test item extracts (both inside and outer surfaces) in Swiss Albino mice. | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
| Material Mediated Pyrogenicity ISO 10993- 11:2017(E) / USP 41 | To determine the pyrogenic potential of the test item extract following intravenous injection in New Zealand white Rabbits. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. |
| Clinical data is not needed for gloves. |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 28, 2023
Latrile Gloves Private Limited % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K230601
Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 23, 2023 Received: March 3, 2023
Dear Manoi Zacharias:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230601
Device Name
Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand 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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3
510(K) SUMMARY K230601 As required by: 21CFR§807.92
A. APPLICANTINFORMATION
| 510(K) Owner's Name | Latrile Gloves Private Limited |
|---|---|
| Address | Plot No : B5 - Sipcot Induatrial Complex, 8th Main road, |
| Pallapatti Village, Nilakottai Taluk, Dindigul Dist - 624201 | |
| Phone | ----- |
| Fax | ----- |
| info@latrile.com | |
| Contact Person | Ragu. M |
| Designation | QMS - Head |
| Contact Number | 8754672072 |
| Contact Email | quality@latrile.com |
| Date Submitted | 22nd February 2023 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | Q-loves |
| Common or usual name | Exam Gloves |
| Classification name | Non-powdered patient examination glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD. |
|---|---|
| 510( K) Number | K192333 |
| Regulatory Class | 1 |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.
E. INTENDED USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
4
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATEDEVICE
| Characteristics | Standards | Device Performance | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | K230601 | ---- | |
| Name of device | JR MEDIC Blue Nitrile | |||
| Examination Gloves | ||||
| Powder-free | Blue Nitrile | |||
| Examination Gloves | ||||
| Powder Free | ---- | |||
| Dimensions | ASTM D6319- | |||
| 2019 | Length Min 230 m Width | |||
| Min 95+/-10 | ||||
| mm(for medium size) | Length Min 230 mm Width | |||
| Min 95+/-10 | ||||
| mm(for medium size) | Same | |||
| Physical Properties | ASTM D6319-2019 | Before Aging | ||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 400% | Before Aging | |||
| Tensile Strength min | ||||
| 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 400% | Same | |||
| Thickness | ASTM D6319-2019 | Palm min 0.05 mm | ||
| Finger min 0.05 mm | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Same | |||
| Powder Residue | ASTM D6319-2019 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary Skin | |||
| Irritation- | ||||
| ISO 10993- | ||||
| 10:2010(E) | Under the condition of | |||
| study not an irritant | Under the condition | |||
| of study not an | ||||
| irritant | Same | |||
| Dermal | ||||
| Sensitization- ISO | ||||
| 10993-10:2010(E) | Under the conditions of | |||
| the study not a sensitizer | Under the conditions | |||
| of the study not a | ||||
| sensitizer | Same | |||
| In vitro cytotoxicity | ||||
| ISO10993-5 | ||||
| :2009(E) | Under the conditions of | |||
| the study, cytotoxic | Under the conditions | |||
| of the study cytotoxic | Same | |||
| Acute Systemic | ||||
| Toxicity Test ISO | ||||
| 10993-11:2017(E) | Under the conditions | |||
| of study the device | ||||
| extracts do not pose a | ||||
| systemic toxicity concern | Under the conditions | |||
| of study the device | ||||
| extracts do not pose a | ||||
| systemic toxicity | ||||
| concern | Same | |||
| Material Mediated | ||||
| Pyrogenicity ISO | ||||
| 10993-11:2017(E) / | ||||
| USP 41 | Under the conditions of | |||
| the study non pyrogenic | Under the conditions | |||
| of the study non | ||||
| pyrogenic | Same | |||
| Characteristics | Standards | Device Performance | Remarks | |
| Predicate | Current | |||
| Water Tight (1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | JR MEDIC Blue Nitrile | |||
| Examination Gloves | ||||
| Powder-free is | ||||
| disposable devices | ||||
| intended for medical | ||||
| purpose that are won on | ||||
| the examiner's hand to | ||||
| prevent contamination | ||||
| between patient and | ||||
| examiner. | Blue Nitrile | |||
| Examination Gloves | ||||
| Powder free is | ||||
| disposable devices | ||||
| intended for medical | ||||
| purpose that are worn | ||||
| on the examiner's | ||||
| hand to prevent | ||||
| contamination | ||||
| between patient and | ||||
| examiner. | Similar | |||
| Material | ASTM | |||
| D6319-2019 | Nitrile | Nitrile | Same | |
| Color | Blue | Blue | Same | |
| Texture | Finger Texture | Finger texture | Same | |
| Size | ASTM | |||
| D6319-2019 | Extra Small, Small, | |||
| Medium, Large, Extra | ||||
| Large | Extra Small, Small, | |||
| Medium, Large, Extra | ||||
| Large | Same | |||
| Single Use | Medical Glove | |||
| Guidance Manual |
- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | | JR Engineering &
Medical
Technologies
(M) SDN.BHD.
Malaysia | Latrile Gloves Private
Limited | ----- |
5
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-2019.
NON-CLINICAL TESTING SUMMARY
| PERFORMANCE DATA | |||
|---|---|---|---|
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6319-2019 Standard | |||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application | To determine the | ||
| length of the gloves | Min 230 mm for all sizes | X-Small:- 245 mm | |
| Small:- 245 mm | |||
| Medium:- 246mm | |||
| Large:- 248 mm | |||
| X-Large:- 248 mm | |||
| ASTM D6319-2019 Standard | |||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application | To determine the | ||
| width of the gloves | X-small:- 70+/-10 mm | ||
| Small:- 80+/-10 mm | |||
| Medium:- 95+/-10mm | |||
| Large:- 110+/-10 mm | |||
| X-Large:- 120+/-10 mm | X-small:- 76 mm | ||
| Small:- 84 mm | |||
| Medium:- 94 mm | |||
| Large:- 105 mm | |||
| X-Large:- 115 mm |
6
| Test Method | Purpose | Acceptance
Criteria | Result | | |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application | To determine the
thickness of the
gloves | Palm 0.05 mm min
Finger 0.05 mm min
for all sizes | Size
X-Small
Small
Medium
Large
X-Large | Palm
0.09mm
0.09mm
0.09mm
0.09mm
0.09mm | Finger
0.15mm
0.15mm
0.15mm
0.15mm
0.15mm |
| ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application | To Determine the
physical properties-
Tensile strength | Before Ageing
Tensile Strength
14Mpa Min for all
sizes
After Ageing
Tensile Strength
14Mpa Min for all
sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
ageing
22.76Mpa
22.77Mpa
24.46Mpa
24.51Mpa
24.59Mpa | After
ageing
20.50Mpa
20.50Mpa
21.81Mpa
21.95Mpa
22.05Mpa |
| ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application | To Determine the
physical properties-
Ultimate Elongation | Before Ageing
Ultimate Elongation
500% Min for all
sizes
After Ageing
Ultimate
Elongation 400%
Min for all sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
ageing
884%
885%
888%
891%
892% | After
ageing
867%
868%
870%
872%
875% |
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D5151-2019 Standard | |||
| Test Method for Detection of | |||
| Holes in Medical Gloves | To determine the | ||
| holes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06 (Reapproved |
- Standard Test Method
for Residual Powder on
Medical Gloves | To determine the
residual powder in
the gloves | 2 Mg/Glove Max | Size
X-small 0.16mg/glove
Small 0.16mg/glove
Medium 0.16 mg/glove
Large 0.16 mg/glove
X-Large 0.16 mg/glove |
7
BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance
Criteria | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10 Biological
Evaluation of Medical Devices
Test for Irritation and Skin
Sensitization. Test done for
irritation. | To determine the potential of
the material under test to
produce dermal irritation in
Rabbits | Under the condition
of study not an
irritant | Under the condition of
study not an irritant |
| ISO 10993-10 Biological
Evaluation of Medical Devices
Test for Irritation and Skin
Sensitization. Test done Skin
sensitization. | To determine the skin
sensitization potential of the
material both in terms of
induction and elicitation in
Guinea Pig. | Under the
conditions of the
study not a
sensitizer | Under the conditions of
the study not a
sensitizer |
| ISO 10993-5:2009 biological
evaluation of medical devices -
part 5, tests for in vitro
cytotoxicity. | To evaluate the in vitro
cytotoxic potential of the test
item (both inner and outer
surface) Extracts in L-929
mouse fibroblasts cells using
elution method. | Under the
conditions of study
non cytotoxic | Under the conditions of
the study cytotoxic. |
| ISO 10993-11:2017 biological
evaluation of medical devices -
part 11, tests for systemic
toxicity. | To determine the acute
systemic toxicity potential of
the test item extracts (both
inside and outer surfaces) in
Swiss Albino mice. | Under the
conditions of study
the device extracts
do not pose a
systemic toxicity
concern | Under the conditions
of study the device
extracts do not pose a
systemic toxicity
concern |
| Material Mediated
Pyrogenicity ISO 10993-
11:2017(E) / USP 41 | To determine the pyrogenic
potential of the test item
extract following intravenous
injection in New Zealand
white Rabbits. | Under the
conditions of the
study, the device
did not
demonstrate a
material mediated
pyrogenicity
response. | Under the conditions of
the study, the device did
not demonstrate a
material mediated
pyrogenicity response. |
G. Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves.
H. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.