(285 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device, Blue Nitrile Examination Gloves, is intended to prevent contamination between the patient and examiner, not to provide therapy or treatment.
No
The device, Blue Nitrile Examination Gloves, is described as preventing contamination between patient and examiner and is classified as patient examination gloves. It does not perform any diagnostic function.
No
The device is a physical examination glove made of nitrile, clearly described as a tangible product and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description identifies the device as "Class I patient examination gloves." This classification is for general medical devices, not specifically for IVDs.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
- Performance Studies: The performance studies focus on the physical properties of the gloves (strength, water tightness, biocompatibility), which are relevant to their barrier function, not their diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This description does not indicate any such function.
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 (comma separated list FDA assigned to the subject device)
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 acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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)
NON-CLINICAL TESTING SUMMARY:
- PERFORMANCE DATA:
- Test Method: ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application
- Purpose: To determine the length of the gloves
- Acceptance Criteria: Min 230 mm for all sizes
- Result: X-Small: 303 mm, Small: 304 mm, Medium: 305mm, Large: 306mm, X-Large: 307mm
- Test Method: ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application
- Purpose: To determine the width of the gloves
- Acceptance Criteria: X-small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm
- Result: X-small: 74 mm, Small: 84 mm, Medium: 94 mm, Large: 104 mm, X-Large: 115 mm
- Test Method: ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application
- Purpose: To determine the thickness of the gloves
- Acceptance Criteria: Palm 0.05 mm min, Finger 0.05 mm min for all sizes
- Result:
- X-Small: Palm 0.10mm, Finger 0.12mm
- Small: Palm 0.10mm, Finger 0.12mm
- Medium: Palm 0.10mm, Finger 0.12mm
- Large: Palm 0.10mm, Finger 0.12mm
- X-Large: Palm 0.10mm, Finger 0.12mm
- Test Method: ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application
- Purpose: To Determine the physical properties - Tensile strength
- Acceptance Criteria:
- Before Ageing: Tensile Strength 14Mpa Min for all sizes
- After Ageing: Tensile Strength 14Mpa Min for all sizes
- Result:
- Before ageing:
- X-Small: 18.44Mpa
- Small: 18.49Mpa
- Medium: 18.56Mpa
- Large: 18.62Mpa
- X-Large: 18.64Mpa
- After ageing:
- X-Small: 17.49Mpa
- Small: 17.53Mpa
- Medium: 17.65Mpa
- Large: 17.71Mpa
- X-Large: 17.76Mpa
- Before ageing:
- Test Method: ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application
- Purpose: To Determine the physical properties - Ultimate Elongation
- Acceptance Criteria:
- Before Ageing: Ultimate Elongation 500% Min for all sizes
- After Ageing: Ultimate Elongation 400% Min for all sizes
- Result:
- Before ageing:
- X-Small: 683%
- Small: 687%
- Medium: 692%
- Large: 695%
- X-Large: 698%
- After ageing:
- X-Small: 656%
- Small: 660%
- Medium: 663%
- Large: 666%
- X-Large: 669%
- Before ageing:
- Test Method: ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application
- Test Method: ASTM D5151-2019 Standard Test Method for Detection of Holes in Medical Gloves
- Purpose: To determine the holes in the gloves
- Acceptance Criteria: AQL 1.5
- Result: Gloves Passes AQL 1.5
- Test Method: ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- Purpose: To determine the residual powder in the gloves
- Acceptance Criteria: 2 Mg/Glove Max
- Result:
- X-small: 0.21mg/glove
- Small: 0.21mg/glove
- Medium: 0.22 mg/glove
- Large: 0.22 mg/glove
- X-Large: 0.22 mg/glove
- BIO-COMPATIBILITY DATA:
- Test Method: ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done for irritation.
- Purpose: To determine the potential of the material under test to produce dermal irritation in Rabbits
- Acceptance Criteria: Under the condition of study not an irritant
- Result: Under the condition of study not an irritant
- Test Method: ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done Skin sensitization.
- Purpose: To determine the skin sensitization potential of the material both in terms of induction and elicitation in Guinea Pig.
- Acceptance Criteria: Under the conditions of the study not a sensitizer
- Result: Under the conditions of the study not a sensitizer
- Test Method: ISO 10993-5:2009 biological evaluation of medical devices - part 5, tests for in vitro cytotoxicity.
- Purpose: 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.
- Acceptance Criteria: Under the conditions of study non cytotoxic
- Result: Under the conditions of the study cytotoxic.
- Test Method: ISO 10993-11:2017 biological evaluation of medical devices - part 11, tests for systemic toxicity.
- Purpose: To determine the acute systemic toxicity potential of the test item extracts (both inside and outer surfaces) in Swiss Albino mice.
- Acceptance Criteria: Under the conditions of study the device extracts do not pose a systemic toxicity concern
- Result: Under the conditions of study the device extracts do not pose a systemic toxicity concern
- Test Method: Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41
- Purpose: To determine the pyrogenic potential of the test item extract following intravenous injection in New Zealand white Rabbits.
- Acceptance Criteria: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response.
- Result: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response.
- Test Method: ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done for irritation.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 28, 2022
Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K212584
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: April 28, 2022 Received: May 2, 2022
Dear Manoj 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.
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
1
Page 2
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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212584
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) |
|---|
| ------------------------------------------------- |
| Serve The Community (21 CFR 601 Subpart C) | X |
|---|---|
| Registration Use (Part 21 CFR 601 Subpart B) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY K212584 As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION
| 510(K) Owner's Name | Amazing Rubber Products Pvt. Ltd. |
|---|---|
| Address | Plot No 14c, Cochin Special Economic Zone, Kakkanad, |
| Cochin-682 037, Kerala- India | |
| Phone | 9447053062 |
| Fax | ----- |
| info@amazingglove.com | |
| Contact Person | Mr. Jayasankar S |
| Designation | Executive Director |
| Contact Number | 9447053062 |
| Contact Email | info@amazingglove.com |
| Date Submitted | 12 August 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | Amazing+ |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| 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 | I |
| 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 acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.
E. INTENDED USE OF THE DEVICE:
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.
4
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATEDEVICE
| Characteristics | Standards | Device Performance | Comparison | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | K212584 | ---- | |
| 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 | $\le$ 2 mg/glove | $\le$ 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 the device | ||||
| extract did not show a | ||||
| material mediated | ||||
| pyrogenicity response. | Under the conditions | |||
| of the study the | ||||
| device extract did | ||||
| not show a material | ||||
| mediated | ||||
| pyrogenicity | ||||
| response. | Same | |||
| Characteristics | Standards | Device Performance | Comparison | |
| 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 | Amazing Rubber
Products Pvt. Ltd. | ------ |
5
NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA Result Test Method Acceptance Criteria Purpose ASTM D6319-2019 Standard To determine the Min 230 mm for all sizes X-Small:- 303 mm Specification for Nitrile length of the gloves Small:-304 mm Examination Gloves Medium:-305mm for Medical Application Large:-306mm X-Large:- 307mm ASTM D6319-2019 Standard To determine the X-small:-70+/-10 mm X-small-74 mm Specification for Nitrile width of the gloves Small:-80+/-10 mm Small:-84 mm Examination Gloves for Medium:- 95+/-10mm Medium:- 94 mm Medical Application Large:-110+/-10 mm Large:-104 mm X-Large:- 120+/-10 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
0.10mm
0.10mm
0.10mm
0.10mm
0.10mm | Finger
0.12mm
0.12mm
0.12mm
0.12mm
0.12mm |
| 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
18.44Mpa
18.49Mpa
18.56Mpa
18.62Mpa
18.64Mpa | After
ageing
17.49Mpa
17.53Mpa
17.65Mpa
17.71Mpa
17.76Mpa |
| 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
683%
687%
692%
695%
698% | After
ageing
656%
660%
663%
666%
669% |
| 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
2017) Standard Test Method
for Residual Powder on
Medical Gloves | To determine the
residual powder in
the gloves | 2 Mg/Glove Max | Size
X-small
Small
Medium
Large
X-Large
Residual Powder
Content
0.21mg/glove
0.21mg/glove
0.22 mg/glove
0.22 mg/glove
0.22 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 or for most devices cleared by the 510(K) process.
H. CONCLUSION
The conclusions drawn from the nonclinical test demonstrate that the subject device in 510(K) submission, Blue Nitrile Examination Gloves Powder Free is as effective, and performs as well as or better than the legally marketed predicate device K192333.