(296 days)
Not Found
No
The device is a physical examination glove and the summary describes its material properties and performance against chemical permeation and physical tests, with no mention of AI or ML.
No.
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to treat a medical condition.
No
Explanation: The device is a medical examination glove, which is used for protection and contamination prevention, not for diagnosing medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not 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 a "patient examination glove... intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for infection control during physical examinations.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of Diagnostic Function: The description and performance studies focus on the physical properties of the glove (dimensions, tensile strength, water leak, powder, dermatitis potential) and its resistance to chemotherapy drugs. There is no mention of the device being used to analyze biological specimens or provide diagnostic information.
Therefore, this device falls under the category of a general medical device used for protection and infection control, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below
| Minimum Breakthrough detection time (minutes) | |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.9 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 11.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D6319-10. It is an ambidextrous medical glove, which is a disposable device, provided in x-small, medium, large and xlarge sizes. In addition, these gloves were tested for use with Chemotherapy Drugs per ASTM D6978-05 "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," and Modified-Draize-95 Test, per FDA guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products," 1999.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
worn on the 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)
The subject device was tested successfully against:
-
a) Measurement of Dimensions according to Standard Practice for Rubber—Measurement of Dimensions ASTM D3767-03 (2014):
Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples was 0; less or equal than the maximum allowable. -
b) Measurement of Tensile test according to Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension ASTM D412-16: Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples was 0; less or equal than the maximum allowable.
-
Measurement of Residual powder according to Standard Test Method for Residual Powder on Medical c) Gloves ASTM D6124-06 (2017): Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples were 0; less or equal than the maximum allowable.
d) Measurement of Water leak test according to Standard Test Method for Detection of Holes in Medical Gloves ASTM D5151-06 (2015): Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. In three of the five lots, the number of defective samples was 1; less or equal than the maximum allowable (which is 2 per lot). In two of the three lots, the number of defective samples was zero; less or equal than the maximum allowable.
- e) Low dermatitis potential according to Standard Test Method For Human Repeat Insult Patch Testing Of Medical Gloves ASTM D6355-07: Under the conditions of the study, there was no clinical evidence of residual chemical additives that may induce Type IV allergy in the un-sensitized general user populations in the tested articles.
- f) Permeation by Chemotherapy Drugs according to Standard Practice For Assessment Of Resistance Of Medical Gloves To Permeation By Chemotherapy Drugs ASTM D6978-05 (Reapproved 2013) Under the conditions of the study, 15 chemotherapy drugs passed the test, while Carmustine (BCNU) (3.3 mg/ml) failed at 15.9 breakthrough detection time (in minutes), and Thiotepa (10.0 mg/ml) failed at 11.1.
- Biocompatibility testing was successfully tested in accordance with ANSI AAMI ISO 10993-5:2009/(R)2014 g) (Cytotoxicity) and ISO 10993-10 Third Edition 2010-08-01 (irritation/sensitization).
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.
October 4, 2019
Semperit Investments Asia PTE LTD. % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075
Re: K183441
Trade/Device Name: Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: August 29, 2019 Received: September 3, 2019
Dear Jay Mansour:
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 mediation-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.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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) K183441
Device Name
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below
| Minimum Breakthrough detection time (minutes) | |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.9 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 11.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.
Type of Use (Select one or both, as applicable)
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) # K183441
510k Summary
As required by 21 CFR 807.92
1- Date summary prepared: September 26, 2019
Owner/Submitter/Sponsor/Applicant information: 2-
SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road, #29-03 To 06 The JTC Summit Singapore 609434
Contact person Name: Jay Mansour, MSQA, BE, RAC Title: regulatory consultant- Mansour Consulting LLC – Principal Phone: (678) 908-8180 Email address: jay@mansourconsulting.com
- 3- Device information:
Common/usual/classification name:
Powder-Free Nitrile Patient Examination Glove
Device name:
Powder-free Nitrile Patient Examination Glove, Green colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
| FDA 3 letter code | LZA, LZC |
|---|---|
| FDA regulation number: 21 CFR | 880.6250 |
| Regulation medical specialty | General Hospital |
| Review panel | General Hospital |
| Class | I |
4- Predicate device:
| 510k number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K151824 | --Powder Free Nitrile Patient Examination Glove, Blue | |
| Colored, Non-Sterile, Low Dermatitis Potential, and | ||
| Tested for use with Chemotherapy Drugs | ||
| --Powder Free Nitrile Patient Examination Glove, White | ||
| Colored, Non-Sterile, Low Dermatitis Potential, and | ||
| Tested for use with Chemotherapy Drugs | KOSSAN INTERNATIONAL | |
| SDN. BHD. |
5- Description of the device:
4
The Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D6319-10. It is an ambidextrous medical glove, which is a disposable device, provided in x-small, medium, large and xlarge sizes. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," and Modified-Draize-95 Test, per FDA guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products," 1999.
- 6- Indications for use
This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below
| Carmustine (BCNU) (3.3 mg/ml) | 15.9 |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 11.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Minimum Breakthrough detection time (minutes)
5
Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.
7- Technological Characteristics:
Shown below is the technological characteristics comparison of the subject device and the predicate device.
| Subject device | Predicate Device | Comments | ||
|---|---|---|---|---|
| Manufacturer | SEMPERIT INVESTMENTS ASIA PTE. LTD. | KOSSAN INTERNATIONAL SDN. BHD. | N/A | |
| 510(k) number | K183441 | K151824 | N/A | |
| Device trade or | ||||
| proprietary name | Powder-free Nitrile Patient Examination Glove, | |||
| Green Colored, Non-sterile, Low Dermatitis | ||||
| Potential, and Tested for Use with | ||||
| Chemotherapy Drugs | Powder Free Nitrile Patient Examination Glove, | |||
| Blue Colored, Non-Sterile, Low Dermatitis Potential, | ||||
| and Tested for use with Chemotherapy Drugs | ||||
| Powder Free Nitrile Patient Examination Glove, | ||||
| White Colored, Non-Sterile, Low Dermatitis | ||||
| Potential, and Tested for use with Chemotherapy | ||||
| Drugs | Identical, except that | |||
| subject device is in | ||||
| green, while | ||||
| predicate device is in | ||||
| blue or white. | ||||
| Device Classification | ||||
| Name/ Regulation number | Patient Examination Glove | |||
| 21 CFR Part 880.6250 | Patient Examination Glove | |||
| 21 CFR Part 880.6250 | Identical | |||
| Product Code | LZA, LZC | LZA, LZC | Identical | |
| Intended Use | This device is an ambidextrous patient | |||
| examination glove that is a non-sterile, single | ||||
| use, disposable device intended for medical | ||||
| purposes, worn on the examiner's hand to | ||||
| prevent contamination between patient and | ||||
| examiner. The tested chemotherapy drugs are: | A patient examination glove is a disposable device | |||
| intended for medical purposes that is worn on the | ||||
| examiner's hand to prevent contamination between | ||||
| patient and examiner. The tested chemotherapy | ||||
| drugs are: | Identical, except for | |||
| lower breakthrough | ||||
| time for Thiotepa. | ||||
| (Both devices are | ||||
| ambidextrous) | ||||
| CARMUSTINE (BCNU) | ||||
| 3.3 MG/ML | ||||
| CISPLATIN | ||||
| 1.0 MG/ML | ||||
| CYCLOPHOSPHAMIDE | ||||
| (CYTOXAN) | ||||
| 20.0 MG/ML | ||||
| CYTARABINE | ||||
| 100 MG/ML | ||||
| DACARBAZINE (DTIC) | ||||
| 10.0 MG/ML | ||||
| DOXORUBICIN | ||||
| HYDROCHLORIDE | ||||
| 2.0 MG/ML | extremely low | |||
| permeation times | ||||
| of 15.9 minutes. | ||||
| no breakthrough | ||||
| up to 240 minutes | ||||
| no breakthrough | ||||
| up to 240 minutes | ||||
| no breakthrough | ||||
| up to 240 minutes | ||||
| no breakthrough | ||||
| up to 240 minutes | ||||
| no breakthrough | ||||
| up to 240 minutes | CARMUSTINE (BCNU) | |||
| 3.3 MG/ML | ||||
| CISPLATIN | ||||
| 1.0 MG/ML | ||||
| CYCLOPHOSPHAMIDE | ||||
| (CYTOXAN) | ||||
| 20.0 MG/ML | ||||
| CYTARABINE | ||||
| 100 MG/ML | ||||
| DACARBAZINE (DTIC) | ||||
| 10.0 MG/ML | ||||
| DOXORUBICIN | ||||
| HYDROCHLORIDE | ||||
| 2.0 MG/ML | extremely low | |||
| permeation times | ||||
| of 10.4 minutes. | ||||
| no breakthrough up | ||||
| to 240 minutes | ||||
| no breakthrough up | ||||
| to 240 minutes | ||||
| no breakthrough up | ||||
| to 240 minutes | ||||
| no breakthrough up | ||||
| to 240 minutes | ||||
| no breakthrough up | ||||
| to 240 minutes |
6
| | ETOPOSIDE
20.0 MG/ML
FLUOROURACIL
50.0 MG/ML
IFOSFAMIDE
50.0 MG/ML
METHOTREXATE
25.0 MG/ML
MITOMYCIN C
0.5 MG/ML
MITOXANTRONE
2.0 MG/ML
PACLITAXEL
(TAXOL)
6.0 MG/ML
THIOTEPA
10.0 MG/ML
VINCRISTINE
SULFATE
1.0 MG/ML | no breakthrough
up to 240 minutes
no breakthrough
up to 240 minutes
no breakthrough
up to 240 minutes
no breakthrough
up to 240 minutes
no breakthrough
up to 240 minutes
no breakthrough
up to 240 minutes
no breakthrough
up to 240 minutes
extremely low
permeation times
of 11.1 minutes
no breakthrough
up to 240 minutes | | ETOPOSIDE
20.0 MG/ML
FLUOROURACIL
50.0 MG/ML
IFOSFAMIDE
50.0 MG/ML
METHOTREXATE
25.0 MG/ML
MITOMYCIN C
0.5 MG/ML
MITOXANTRONE
2.0 MG/ML
PACLITAXEL
(TAXOL)
6.0 MG/ML
THIOTEPA
10.0 MG/ML
VINCRISTINE
SULFATE
1.0 MG/ML | no breakthrough up
to 240 minutes
no breakthrough up
to 240 minutes
no breakthrough up
to 240 minutes
no breakthrough up
to 240 minutes
no breakthrough up
to 240 minutes
no breakthrough up
to 240 minutes
no breakthrough up
to 240 minutes
breakthrough after
90.5 minutes
no breakthrough up
to 240 minutes | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Materials | Nitrile | | Nitrile | | Identical | |
| Color | Green | | | Blue or White | | Similar (green
versus blue) |
| Standards used | ASTM D6319-10
ASTM D5151-06
ASTM D6124-06
ASTM D6978-05(2013)
ASTM D412-16
ASTM D3767-03
ANSI/AAMI/ISO 10993-5
ISO 10993-10
ISO 2859-1 | | | ASTM D6319-10
ASTM D5151-11
ASTM D6124-11
ASTM D6978-05 (Reapproved 2013)
ISO 10993-10 | Identical
Note: ASTM D412-16,
D3767-03 and ISO
2859-1 are
supporting standards | |
| Non-Sterile, Single Use,
disposable | Yes | | Yes | | Identical | |
| Packaging | Packed in Dispenser Boxes | | | Packed in Dispenser Boxes | Identical | |
| Labeling Features | Non-Sterile
Powder Free
Examination Gloves
Ambidextrous, by Size
Single use only
Device Color
Manufactured by:
Lot Number:
Quantity by Weight
Made in Malaysia | | | Non-Sterile
Powder Free
Examination Gloves
Ambidextrous, by Size
Single use only
Device Color
Manufactured by:
Lot Number:
Quantity by Weight
Made in Malaysia | | Identical |
| Sizes | X-Small, Small, Medium, Large, X-Large | | | X-Small, Small, Medium, Large, X-Large | | Identical |
| Labeling Claim | 1. Low Dermatitis Potential
2. Tested for Use with Chemotherapy Drugs | | | 1. Low Dermatitis Potential
2. Tested for Use with Chemotherapy Drugs | | Identical |
| Biocompatibility | Cytotoxicity compliant as per ANSI/AAMI/ISO
10993-5
Sensitization and irritation compliant as per ISO
10993-10 | | | Sensitization and irritation compliant as per ISO
10993-10 | | Identical for
sensitization and
irritation. Our subject
device also tested for
Cytotoxicity |
| Modified Draize Test | Under the conditions of the study, there was no
clinical evidence of the presence of residual | | | Under the conditions of the study, there was no
clinical evidence of the presence of residual | | Identical |
7
| chemical additives that may induce Type IV allergy in the un-sensitized general user populations in the tested articles | chemical additives that may induce Type IV allergy in the un-sensitized general user populations in the tested articles |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------- |
-
- Summary of Non-Clinical Performance Test
The subject device was tested successfully against:
- Summary of Non-Clinical Performance Test
-
a) Measurement of Dimensions according to Standard Practice for Rubber—Measurement of Dimensions ASTM D3767-03 (2014):
Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples was 0; less or equal than the maximum allowable. -
b) Measurement of Tensile test according to Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension ASTM D412-16: Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples was 0; less or equal than the maximum allowable.
-
Measurement of Residual powder according to Standard Test Method for Residual Powder on Medical c) Gloves ASTM D6124-06 (2017): Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples were 0; less or equal than the maximum allowable.
d) Measurement of Water leak test according to Standard Test Method for Detection of Holes in Medical Gloves ASTM D5151-06 (2015): Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. In three of the five lots, the number of defective samples was 1; less or equal than the maximum
allowable (which is 2 per lot). In two of the three lots, the number of defective samples was zero; less or equal than the maximum allowable.
- e) Low dermatitis potential according to Standard Test Method For Human Repeat Insult Patch Testing Of Medical Gloves ASTM D6355-07: Under the conditions of the study, there was no clinical evidence of residual chemical additives that may induce Type IV allergy in the un-sensitized general user populations in the tested articles.
- f) Permeation by Chemotherapy Drugs according to Standard Practice For Assessment Of Resistance Of Medical Gloves To Permeation By Chemotherapy Drugs ASTM D6978-05 (Reapproved 2013) Under the conditions of the study, 15 chemotherapy drugs passed the test, while Carmustine (BCNU) (3.3 mg/ml) failed at 15.9 breakthrough detection time (in minutes), and Thiotepa (10.0 mg/ml) failed at 11.1.
- Biocompatibility testing was successfully tested in accordance with ANSI AAMI ISO 10993-5:2009/(R)2014 g) (Cytotoxicity) and ISO 10993-10 Third Edition 2010-08-01 (irritation/sensitization)
8
9. Summary of Clinical Test
Not applicable.
10. Conclusion
The conclusions drawn from the nonclinical (discussed above) demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device