(98 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 intended to prevent contamination, not to provide therapy or treatment.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, 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 are based on physical testing methods for gloves (ASTM standards). There is no mention of software as the primary or sole component.
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 a sample from the body.
- Device Description: The description identifies them as "patient examination gloves," which are a type of medical device used for protection, not diagnosis.
- Lack of Diagnostic Elements: The description and performance studies focus on the physical properties of the gloves (hole detection, powder residue) and biocompatibility, not on analyzing biological samples or providing diagnostic information.
- No Mention of IVD Activities: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which are the hallmarks of IVD devices.
Therefore, based on the provided information, these gloves are classified as a medical device for barrier protection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SHARK GLOVES and INCONGLOVE 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
SHARK GLOVES and INCONGLOVE 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 and are powder free
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing was performed, including:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application, to determine length, width, thickness, physical properties (tensile strength, ultimate elongation).
- ASTM D5151-19 Standard Test Method for detection of holes in medical gloves, to determine holes in gloves.
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves, to determine residual powder in gloves.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization, to determine potential for dermal irritation in Rabbits and skin sensitization potential in Guinea Pig.
- ISO 10993-5:2009 biological evaluation of medical devices - part 5, tests for in vitro cytotoxicity, to evaluate in vitro cytotoxic potential of test item extracts in L-929 mouse fibroblasts cells.
- ISO 10993-11:2017 biological evaluation of medical devices - part 11, tests for systemic toxicity, to determine acute systemic toxicity potential of test item extracts in swiss Albino mice.
All tests indicated "Pass" or "Under the condition of study not an irritant/sensitizer/toxicity concern", where applicable. For in vitro cytotoxicity, the result was "Under the conditions of the study. cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern." and the systemic toxicity test showed "Under the conditions of study the device extracts do not pose a systemic toxicity concern".
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 contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2021
Srirungruang Global Co., LTD. % Aristotle Nafpliotis Regulatory Affairs Consultant/Engineer mdi Consultants. Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K212308
Trade/Device Name: SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE 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: September 27, 2021 Received: September 28, 2021
Dear Aristotle Nafpliotis:
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
542 of the Act); 21 CFR 1000-1050.
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-
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K212308
Device Name
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free INCONGLOVE Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
SHARK GLOVES and INCONGLOVE 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.
| 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
Image /page/3/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a stylized shark fin above the word "SHARK" in a smaller font, stacked above the word "GLOVES" in a larger font. The text and shark fin are outlined in black, with the interior of the fin filled in with a dark blue color.
510(k) SUMMARY
The assigned 510(k) number is: K212308.
1. Submitter's Identification:
- SRIRUNGRUANG GLOBAL CO., LTD Name:
51/7 MOO 1, MABPHAI, BANBUNG, CHONBURI 20170 THAILAND Address:
Phone no.: +66(0)38 151671
+66(0)38 151672 Fax no:
| Contact person: | Mr.Suttichai Sripradub |
|---|---|
| ----------------- | ------------------------ |
Designation: Managing Director
Manufacturer:
| Name: | SRIRUNGRUANG GLOBAL CO., LTD |
|---|---|
| Address: | 51/7 MOO 1, MABPHAI, BANBUNG, CHONBURI 20170 THAILAND |
| Phone no.: | +66(0)38 151671 |
| Fax no: | +66(0)38 151672 |
Exporter: SRIRUNGRUANG GLOBAL CO., LTD.
Date Summary Prepared: May 31, 2021
4
Image /page/4/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized shark fin in blue, with a white outline. Below the shark fin, the words "SHARK" and "GLOVES" are stacked on top of each other in a bold, sans-serif font, also in blue with a white outline. The overall design is clean and sporty.
2. Device Identification
| Name of the Device: | SHARK GLOVES Blue Nitrile Examination Glove
Powder Free
INCONGLOVE Blue Nitrile Examination Gloves
Powder free |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------|
| Trade Name (s): | SHARK GLOVES, INCONGLOVE |
| Common or usual name: | Exam Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Non-powdered patient examination gloves. |
| Regulatory Class: | I |
| Product Code: | LZA |
| Review Panel: | General Hospital |
Information for the 510(k) Cleared Device (Predicate Device): 3.
| Predicate Device: | JR MEDIC Blue Nitrile Examination Gloves Powder
Free |
|-------------------|---------------------------------------------------------|
| Owner: | JR Engineering & Medical Technologies (M) SDN.BHD. |
| 510(k) Number: | K192333 |
| Regulatory Class: | I |
| Product Code: | LZA |
4. Device Description:
SHARK GLOVES and INCONGLOVE 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 and are powder free
ട്. Indications for Use:
SHARK GLOVES and INCONGLOVE 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
5
Image /page/5/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized shark fin in blue, with a white outline, positioned above the text "SHARK" and "GLOVES", which are stacked on top of each other. The text is in a bold, sans-serif font, with a white outline and a black shadow, giving it a three-dimensional effect. The overall design is sporty and eye-catching.
6. Technological Characteristic Comparison of Proposed and Predicate Devices:
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |
|---|---|---|---|---|
| PREDICATE | SUBJECT | |||
| 510(k) Number | K192333 | K212308 | ------ | |
| Name of device | Blue Nitrile | |||
| Examination Gloves | ||||
| Powder Free | SHARK GLOVES and | |||
| INCONGLOVE | ------ | |||
| Dimensions | ASTMD6319-10 | |||
| (Reapproved 2015) | ||||
| ASTMD6319-19 | Length Min 230 mm | |||
| Width Min 95+/-10 | ||||
| mm(for medium size) | Length Min 230 mm | |||
| Width Min 95+/-10 | ||||
| mm(for medium size) | Same | |||
| Physical Properties | ASTMD6319-10 | |||
| (Reapproved 2015) | ||||
| ASTMD6319-19 | 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% | Similar | |||
| Thickness | ASTMD6319-10 | |||
| (Reapproved 2015) | ||||
| ASTMD6319-19 | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Same | |||
| Powder Free, Powder | ||||
| residue | ASTMD6319-10 | |||
| ASTMD6319-19 | ≤2 mg/glove | ≤2 mg/glove | Similar | |
| Biocompatibility | Primary Skin | |||
| Irritation-ISO 1993- | ||||
| 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. | ||||
| Additional testing was | ||||
| performed to | ||||
| determine if this was | ||||
| a systemic toxicity | ||||
| concern | Under the conditions of | |||
| the study, cytotoxic. | ||||
| Additional testing was | ||||
| performed to determine | ||||
| if this was a systemic | ||||
| toxicity | ||||
| concern | Similar | |||
| Acute Systemic | ||||
| Toxicity Test ISO | ||||
| 10993-11:2017(E) | Under the condition | |||
| of study the device | ||||
| extracts do not pose a | ||||
| systemic toxicity | ||||
| concern | Under the condition | |||
| of study the device | ||||
| extracts do not pose a | ||||
| systemic toxicity | ||||
| concern | Similar | |||
| Material Mediated | ||||
| Pyrogenicity ISO | ||||
| 10993-11:2017(E) / | ||||
| USP 41 | 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. | Similar | |||
| Water Tight (1000 ml), | ||||
| Freedom from holes | ASTM D5151-06 | |||
| ASTM D5151-19 | Passes AQL-2.5 | Passes | Similar | |
| Indications for Use | JR MEDIC Blue | |||
| Nitrile Examination | ||||
| Gloves Powder Free | ||||
| is disposable device | ||||
| intended for medical | ||||
| purpose that are won | ||||
| on the examiner's | ||||
| hand to prevent | ||||
| contamination | ||||
| between patient and | ||||
| examiner. | SHARK GLOVES and | |||
| INCONGLOVE Blue | ||||
| Nitrile Examination | ||||
| Gloves Powder Free are | ||||
| disposable devices | ||||
| intended for medical | ||||
| purpose that are won on | ||||
| the examiner's hand to | ||||
| prevent contamination | ||||
| between patient and | ||||
| examiner. | Similar | |||
| Material | ASTMD6319- | |||
| 10(Reapproved | ||||
| ASTMD6319-19 | Nitrile | Nitrile | Same | |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTMD6319-10 | |||
| (Reapproved 2015) | ||||
| ASTMD6319-19 | Extra Small, Small, | |||
| Medium, Large, Extra | ||||
| Large | Small, Medium, Large, | |||
| Extra Large | Similar | |||
| Single Use | Medical Glove | |||
| Guidance Manual - | ||||
| Labeling | Single Use | Single Use | Same | |
| Manufacturer(s) | - | JR Engineering & | ||
| Medical Technologies | ||||
| (M) SDN.BHD. | ||||
| Malaysia. | SRIRUNGRUANG | |||
| GLOBAL CO., LTD. | ||||
| 51/7 ΜΟΟ 1, | ||||
| MABPHAI, BANBUNG | ||||
| ,CHONBURI | ||||
| 20170 THAILAND |
6
Image /page/6/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK" and "GLOVES" are stacked on top of each other in a bold, sans-serif font, also in blue with a white outline. The overall design is sporty and suggests a brand associated with athletic or protective gloves.
7
Image /page/7/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a blue shark with a white outline above the word "GLOVES" in large, bold, red letters. The word "SHARK" is in smaller, black letters above the word "GLOVES".
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 standards.
7. Summarv of Non-Clinical Testing:
8
Image /page/8/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK" and "GLOVES" are stacked on top of each other in a stylized font. The word "SHARK" is slightly smaller and positioned above the word "GLOVES".
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-19 | |||
| Standard Specification for | |||
| Nitrile Examination Gloves | |||
| for Medical Application | To determine the | ||
| length of the gloves | Min 230 mm for all sizes | Small: Pass | |
| Medium: Pass | |||
| Large: Pass | |||
| X-Large: Pass | |||
| ASTM D6319-19 | |||
| Standard Specification for | |||
| Nitrile Examination Gloves | |||
| for Medical Application | To determine the | ||
| width of the gloves | Small: -80+/-10 mm | ||
| Medium: -95+/-10mm | |||
| Large: -110+/-10 mm | |||
| X-Large: -120+/-10 mm | Small: Pass | ||
| Medium: Pass | |||
| Large: Pass | |||
| X-Large: Pass |
| Test Method | Purpose | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|
| ASTM D6319-19 | |||||
| Standard Specification for | |||||
| Nitrile Examination Gloves | |||||
| for Medical Application | To determine | ||||
| the length of the | |||||
| gloves | Palm 0.05 mm min | ||||
| Finger 0.05 mm min | |||||
| for all sizes | Size | ||||
| Small | |||||
| Medium | |||||
| Large | |||||
| X-large | Palm | ||||
| Pass |
| Finger
Pass
|
| ASTM D6319-19
Standard Specification
physical properties- for
Nitrile Examination Gloves
Ultimate Elongation 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 size | Size
Small
Medium
Large
X-large |
Pass
|
Pass
|
| | To Determine the
physical properties
Ultimate Elongation | Before Ageing
Ultimate Elongation
500% Min for all
Size After Ageing | Size
Small
Medium | Before
ageing
Pass | After
ageing
Pass |
9
Image /page/9/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK GLOVES" are written in a bold, stylized font, with "SHARK" stacked above "GLOVES". The text also has a white outline, making it stand out against the background.
| | | Ultimate Elongation
400% Min for all sizes | Large
X-large | | |
| -- | -- | ----------------------------------------------- | ------------------ | -- | -- |
|---|
| Test Method | Purpose | Acceptance
Criteria | Result |
|--------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|---------------------------------------------|
| ASTM D5151-19
Standard Test Method for
detection of holes in
medical gloves | To determine the holes
in the gloves | AQL 2.5 | Pass |
| ASTM D6124-06
Standard Test Method for
Residual Powder on
Medical Gloves | To determine the
residual powder in the
gloves | 2 Mg/Glove Max | Size
Small
Medium
Large
X-Large |
| | | | Residual Powder
Content
Pass |
The indications for use, materials, size and models are all similar. Both the subject and predicate devices are shown to be biocompatible and meet the specifications of the ASTM standard D6319-10.
BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ------------- | --------- | --------------------- | -------- |
10
Image /page/10/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a blue shark with a white outline. The words "SHARK" and "GLOVES" are stacked on top of each other in red font below the shark. The logo has a sporty and dynamic feel.
| ISO 10993-10:2010
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 |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO10993-10:2010
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.
Additional testing
was performed to
determine if this
was a systemic
toxicity concern. |
| 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 |
8. Discussion of Clinical Tests Performed:
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9. Conclusions:
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 predicate device.