(390 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.
No
The device, blue nitrile examination gloves, is intended to prevent contamination between patient and examiner, not to treat or alleviate a medical condition.
No
Explanation: The device is described as "Examination Gloves" intended "to prevent contamination between patient and examiner." Its function is barrier protection, not diagnosis. It does not analyze or interpret medical data to provide information for diagnosis.
No
The device is a physical product (examination gloves) and the summary describes material properties and physical performance testing, not software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for preventing contamination between patient and examiner by being worn on the examiner's hand. This is a physical barrier function, not a diagnostic test performed on samples from the body.
- Device Description: The description details the material, color, and physical characteristics of the gloves. It also mentions the product code and classification (Class I patient examination gloves), which aligns with personal protective equipment, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
The device is a medical device, specifically a Class I examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Dainam JSC., Powder Free Gloves 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 and are powder free, non-sterile, single use and disposable and available in size XS-extra small, S-small, M-medium, L-Large, XL- Extra-large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Applicable
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purpose)
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 tests were conducted to verify that the proposed device complies with the following standards:
-
- ISO 10993-10:2009 MTT Method MEM with 10%FBS extract: In Vitro Cytotoxicity Test of NITRILE EXAM GLOVES.
-
- ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% sodium Chloride Injection Extract: Sensitization Test of NITRILE EXAM GLOVES.
-
- ISO 10993-10:2010 0.9% sodium Chloride Injection Extract: Skin Irritation Test of NITRILE EXAM GLOVES.
-
- ISO 10993-10:2010 Guinea Pig Maximization Test Sesame Oil Extract: Sensitization Test of NITRILE EXAM GLOVES.
-
- ISO 10993-10:2010 Sesame Oil Extract: Skin Irritation Test of NITRILE EXAM GLOVES.
-
- ISO 10993-11:2017 Intravenous 0.9% Sodium Chloride Injection Extract: Acute Systemic Toxicity Test of NITRILE EXAM GLOVES.
-
- ISO 10993-11:2017 Intravenous Sesame Oil Extract: Acute Systemic Toxicity Test of NITRILE EXAM GLOVES
-
- ISO 10993-11:2017 0.9% Sodium Chloride Injection Injection Extract Rabbit: Pyrogen Test of NITRILE EXAM GLOVES
-
- ASTM D6319-19, Standard Specification for Gloves for Medical Application.
Summary of key results:
- Length: X-Small: +/-240 mm, Small: +/-240 mm, Medium: +/-240 mm, Large: +/-240 mm, X-Large: +/-240 mm (Acceptance Criteria: Min 230 mm for all sizes)
- Width: X-Small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm (Acceptance Criteria: Same as result)
- Thickness: Palm 0.07mm (all sizes), Finger X-Small 0.10mm, Small 0.9mm, Medium 0.9mm, Large 0.8mm, X-Large 0.7mm (Acceptance Criteria: Palm 0.05 mm min, Finger 0.05 mm min for all sizes)
- Physical properties - Tensile strength (Before ageing): 27Mpa (X-Small), 26Mpa (Small), 25Mpa (Medium), 33Mpa (Large), 32Mpa (X-Large) (Acceptance Criteria: 14Mpa Min for all sizes)
- Physical properties - Tensile strength (After ageing): 25Mpa (X-Small), 26Mpa (Small), 27Mpa (Medium), 36Mpa (Large), 33Mpa (X-Large) (Acceptance Criteria: 14Mpa Min for all sizes)
- Physical properties - Ultimate Elongation (Before ageing): 520% (X-Small), 567% (Small), 553% (Medium), 568% (Large), 539% (X-Large) (Acceptance Criteria: 500% Min for all sizes)
- Physical properties - Ultimate Elongation (After ageing): 509% (X-Small), 545% (Small), 538% (Medium), 560% (Large), 570% (X-Large) (Acceptance Criteria: 400% Min for all sizes)
- Holes: Passes AQL 2.5 (Acceptance Criteria: AQL 2.5)
- Residual powder: X-small 0.3mg/glove, Small 1.4mg/glove, Medium 2 mg/glove, Large 0.5 mg/glove, X-Large 0.7mg/glove (Acceptance Criteria: 2 Mg/Glove Max)
- Irritation: Under the condition of study not an irritant (Acceptance Criteria: Under the condition of study not an irritant)
- Skin sensitization: Under the conditions of the study not a sensitizer (Acceptance Criteria: Under the conditions of the study not a sensitizer)
- In vitro cytotoxicity: Under the conditions of the study cytotoxic. (Acceptance Criteria: Under the conditions of study non cytotoxic)
- Systemic toxicity: Under the conditions of study the device extracts do not pose a systemic toxicity concern (Acceptance Criteria: Under the conditions of study, the device extracts do not pose a systemic toxicity concern)
- Material Mediated Pyrogenicity: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response (Acceptance Criteria: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response.)
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 & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
September 24, 2022
Dainam Glove Joint Stock Company % Jenny Nguyen Office Manager Bayneto LLC 13480 Veterans Memorial Drive, Suite F Houston, Texas 77014
Re: K212751
Trade/Device Name: Powder Free Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA Dated: August 16, 2022 Received: August 18, 2022
Dear Jenny Nguyen:
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, 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212751
Device Name Powder Free Nitrile Examination Glove
Indications for Use (Describe)
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.
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 - K212751
| Submitted by: | Dai Nam JSC.
1765A Thu Dau Mot
Hiep An Ward, Thu Dau Mot, Vietnam. |
|--------------------|--------------------------------------------------------------------------|
| Contact Person: | Damon Nguyen
Director of U.S. Market
dqn1967@gmail.com |
| Telephone Number: | 832-458-4388 |
| Date submitted: | September 20, 2022 |
| Trade/Device Name: | Powder Free Nitrile Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Non-powdered Patient Examination Glove |
| Regulatory Class: | Class I |
| Product Code: | LZA |
Identification of the legally marketed device:
| Predicate Device Name: | Powder Free Black Nitrile Examination Glove |
|---|---|
| Predicate 510(K) Number: | K201428 |
| Manufacturer's Name: | VIETGLOVE CORPORATION |
5.1 Product Description
Dainam JSC., Powder Free Gloves 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 and are powder free, non-sterile, single use and disposable and available in size XS-extra small, S-small, M-medium, L-Large, XL- Extra-large.
5.2 Intended Use/Indications for Use
Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
4
| Product | K201428 | K212751 | Results |
|---|---|---|---|
| (Predicate) | (Subject) | ||
| Design and Size | |||
| Availability | S,M,L | XS,S,M,L,XL | Similar |
| Materials | Nitrile (Acrylonitrile | ||
| butadiene) | Nitrile (Acrylonitrile | ||
| butadiene) | Same | ||
| Intended | |||
| use/Indication | |||
| for Use | Non-Powdered Patient | ||
| Examination Glove are | |||
| disposable gloves used | |||
| during medical | |||
| examinations and | |||
| procedures to help | |||
| prevent cross- | |||
| contamination between | |||
| caregivers and patients | Blue Nitrile | ||
| Examination Gloves | |||
| Powder Free are | |||
| disposable devices | |||
| intended for medical | |||
| purpose that are worn | |||
| on the examiner's hand | |||
| to prevent | |||
| contamination between | |||
| patient and examiner. | Similar | ||
| Color | Black | Blue | ... |
| Product Code | LZA | LZA | Same |
| Classification | Class 1 | Class 1 | Same |
| 510(K) Number | K201428 | K212751 | ... |
5.3 Comparison of Technological Characteristics
| Characteristics | Standards | Device Performance | Comparison | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K201428 | K212751 | --- | |
| Name of device | Powder Free Black | |||
| Nitrile Examination | ||||
| Glove | Powder Free Nitrile | |||
| Examination Glove | --- | |||
| Dimensions | ASTM D6319- | |||
| 2019 | Length Min 242 m | |||
| Width Min 95+/-10 | ||||
| mm (for medium size) | Length Min 230 mm | |||
| Width Min 95+/-10 | ||||
| mm (for medium size) | Similar | |||
| Characteristics | Standards | Device Performance | Comparison | |
| Predicate | Subject | |||
| 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 508% | Before Aging | |||
| Tensile Strength min | ||||
| 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging Tensile | ||||
| Strength min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 505% | Similar | |||
| Thickness | ASTM D6319-2019 | Palm min 0.06 mm Finger | ||
| min 0.11 mm | Palm min 0.06 mm | |||
| Finger min 0.09 mm | ||||
| Powder Residue | ASTM D6319-2019 | S: 0.43mg/glove | ||
| M: 0.31 mg/glove | ||||
| L: 0.47 mg/glove | XS: 0.3mg/glove | |||
| S: 1.4mg/glove | ||||
| M: 2.0 mg/glove | ||||
| L: 0.5 mg/glove | ||||
| XL: 0.7mg/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 | N/A | Under the conditions of | ||
| the study the device | ||||
| extract did not show a | ||||
| material mediated | ||||
| pyrogenicity response. | Different | |||
| Watertight (1000 | ||||
| ml) | ASTM D5151-2019 | Passes AQL-2.5 | Passes AQL-2.5 | Similar |
| Material | ASTM D6319-2019 | Nitrile | Nitrile | Same |
| Color | - | Black | Blue | Different |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM | |||
| D6319-2019 | Small, Medium, Large | Extra Small, Small, | ||
| Medium, Large, Extra | ||||
| Large | Similar | |||
| Sterility | - | Non-sterile | Non-sterile | Same |
| Characteristics Standards | Device Performance | Comparison | ||
| Predicate | Subject | |||
| Single Use | Medical Glove | |||
| Guidance Manual | Single Use | Single Use | Same | |
| Manufacturer(s) | - | Vietglove | ||
| Corporation | DaiNam Glove JSC | ------ |
5
6
5.4 Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device complies with the following standards:
-
- ISO 10993-10:2009 MTT Method MEM with 10%FBS extract: In Vitro Cytotoxicity Test of NITRILE EXAM GLOVES.
-
- ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% sodium Chloride Injection Extract: Sensitization Test of NITRILE EXAM GLOVES.
-
- ISO 10993-10:2010 0.9% sodium Chloride Injection Extract: Skin Irritation Test of NITRILE EXAM GLOVES.
-
- ISO 10993-10:2010 Guinea Pig Maximization Test Sesame Oil Extract: Sensitization Test of NITRILE EXAM GLOVES.
-
- ISO 10993-10:2010 Sesame Oil Extract: Skin Irritation Test of NITRILE EXAM GLOVES.
-
- ISO 10993-11:2017 Intravenous 0.9% Sodium Chloride Injection Extract: Acute Systemic Toxicity Test of NITRILE EXAM GLOVES.
-
- ISO 10993-11:2017 Intravenous Sesame Oil Extract: Acute Systemic Toxicity Test of NITRILE EXAM GLOVES
-
- ISO 10993-11:2017 0.9% Sodium Chloride Injection Extract Rabbit: Pyrogen Test of NITRILE EXAM GLOVES
-
- ASTM D6319-19, Standard Specification for Gloves for Medical Application.
| Test Method | Purpose | Acceptance Criteria | Result | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-2019 Standard | |||||||||||||||||||||
| Specification for Gloves for Medical | |||||||||||||||||||||
| Application | To determine the | ||||||||||||||||||||
| length of the gloves | Min 230 mm for all sizes | X-Small: +/-240 mm | |||||||||||||||||||
| Small: +/-240 mm | |||||||||||||||||||||
| Medium: +/-240 mm | |||||||||||||||||||||
| Large: +/-240 mm | |||||||||||||||||||||
| X-Large: +/-240 mm | |||||||||||||||||||||
| ASTM D6319-2019 Standard | |||||||||||||||||||||
| Specification for 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+/-10mm X- | |||||||||||||||||||||
| Large: 120+/-10 mm | X-Small: 70+/-10 mm | ||||||||||||||||||||
| Small: 80+/-10 mm | |||||||||||||||||||||
| Medium: 95+/-10mm | |||||||||||||||||||||
| Large: 110+/-10 mm | |||||||||||||||||||||
| X-Large: 120+/-10 mm | |||||||||||||||||||||
| ASTM D6319-2019 Standard | |||||||||||||||||||||
| Specification for 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 Palm Finger X-Small 0.07mm 0.10mm Small 0.07mm 0.9mm Medium 0.07mm 0.9mm Large 0.07mm 0.8mm X-Large 0.07mm 0.7mm |
7
| Test Method | Purpose | Acceptance Criteria | Size | Result | |
|---|---|---|---|---|---|
| ASTM D6319-2019 Standard | |||||
| Specification for 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 | X-Small | ||||
| Small | |||||
| Medium | |||||
| Large | |||||
| X-Large | Before | ||||
| ageing | |||||
| 27Mpa | |||||
| 26Mpa | |||||
| 25Mpa | |||||
| 33Mpa | |||||
| 32Mpa | After | ||||
| ageing | |||||
| 25Mpa | |||||
| 26Mpa | |||||
| 27Mpa | |||||
| 36Mpa | |||||
| 33Mpa | |||||
| 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 | X-Small | ||||
| Small | |||||
| Medium | |||||
| Large | |||||
| X-Large | Before | ||||
| ageing | |||||
| 520% | |||||
| 567% | |||||
| 553% | |||||
| 568% | |||||
| 539% | After | ||||
| ageing | |||||
| 509% | |||||
| 545% | |||||
| 538% | |||||
| 560% | |||||
| 570% |
| 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 2.5 | Gloves Passes AQL 2.5 |
| 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 0.3mg/glove
Small 1.4mg/glove
Medium 2 mg/glove
Large 0.5 mg/glove
X-Large 0.7mg/glove |
5.5 BIOCOMPATIBILITY DATA
8
| 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 glove 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 glove 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 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 in 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 | To determine the pyrogenic
potential of the test item
extract following intravenous
injection in 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. |
5.6 Summary of Clinical Testing
Not applicable - Clinical data is not needed for the subject gloves.
5.7 Conclusion
The conclusions drawn from the non-clinical test demonstrate that the subject device is as safe as effective and performs as well as or better than the legally marketed predicated device.