(88 days)
Not Found
No
The device is a physical examination glove and the summary describes standard testing for physical properties and chemical resistance, with no mention of AI or ML.
No
The device is described as a disposable glove intended to prevent contamination between the patient and examiner, primarily serving a barrier protection function rather than providing therapy.
No
The device description indicates it is a "blue nitrile examination glove powder free" used to "prevent contamination between patient and examiner," which is a protective barrier, not a tool for diagnosing medical conditions.
No
The device is a physical examination glove made of nitrile, clearly described as a tangible product and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- Device Description: The description details a "patient examination glove" made from nitrile. This is consistent with a medical glove, not a diagnostic device.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. The testing mentioned is for the glove's performance characteristics (physical properties, watertightness, biocompatibility, and resistance to chemotherapy drugs), not for diagnosing anything.
- Regulatory Classification: The device is classified as "21CFR 880.6250, class I," which is the classification for patient examination gloves. IVD devices have different classifications (typically Class I, II, or III depending on the risk, but under a different part of the CFR, like 21 CFR Part 866 for Immunology and Microbiology Devices, or 21 CFR Part 864 for Hematology and Pathology Devices).
In summary, the device is a medical glove used for protection, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I).
The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
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 / 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 testing was conducted, including physical properties (length, width, thickness, tensile strength, ultimate elongation, watertighntess, powder free residue) and biocompatibility (Primary Skin Irritation, Dermal Sensitization, In vitro cytotoxicity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Bacterial Endotoxin). Additionally, the gloves were tested for permeation by chemotherapy drugs as per ASTM D6978-05 (2019), with minimum breakthrough detection times reported for 15 drugs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include:
- Length: Small:- 245 mm, Medium:- 246 mm, Large:- 248 mm, X-Large:- 248 mm (Acceptance Criteria: Min 220 mm for Size Small & Min 230 mm for all other sizes)
- Width: Small:- 80 mm, Medium:- 92 mm, Large:- 105 mm, X-Large:- 115 mm (Acceptance Criteria: Small:- 80+/-10 mm, Medium:- 95+/-10 mm, Large:- 110+/-10 mm, X-Large:- 120+/-10 mm)
- Thickness (Palm): 0.09 mm for all sizes (Acceptance Criteria: 0.05 mm min for all sizes)
- Thickness (Finger): 0.15 mm for all sizes (Acceptance Criteria: 0.05 mm min for all sizes)
- Tensile Strength (Before Ageing): 18.52 Mpa (Small), 18.61 Mpa (Medium), 18.67 Mpa (Large), 18.72 Mpa (X-Large) (Acceptance Criteria: 14Mpa Min for all sizes)
- Tensile Strength (After Ageing): 17.54 Mpa (Small), 17.68 Mpa (Medium), 17.74 Mpa (Large), 17.80 Mpa (X-Large) (Acceptance Criteria: 14Mpa Min for all sizes)
- Ultimate Elongation (Before Ageing): 690% (Small), 693% (Medium), 702% (Large), 705% (X-Large) (Acceptance Criteria: 500% Min for all sizes)
- Ultimate Elongation (After Ageing): 665% (Small), 667% (Medium), 669% (Large), 673% (X-Large) (Acceptance Criteria: 400% Min for all sizes)
- Watertight (1000 ml): Passes AQL 1.5 (Acceptance Criteria: Passes AQL-2.5)
- Powder Free Residue: 0.21 mg/glove (Small), 0.22 mg/glove (Medium), 0.22 mg/glove (Large), 0.22 mg/glove (X-Large) (Acceptance Criteria: 240 Minutes
- Cisplatin (1 mg/ml): >240 Minutes
- Cyclophosphamide (Cytoxan) (20 mg/ml): >240 Minutes
- Dacarbazine (10.0 mg/ml): >240 Minutes
- Doxorubicin HCl (2 mg/ml): >240 Minutes
- Etoposide (20 mg/ml): >240 Minutes
- Fluorouracil (50 mg/ml): >240 Minutes
- Ifosfamide (50 mg/ml): >240 Minutes
- Methotrexate (25 mg/ml): >240 Minutes
- Mitomycin C (0.5 mg/ml): >240 Minutes
- Mitoxantrone (2 mg/ml): >240 Minutes
- Paclitaxel (6 mg/ml): >240 Minutes
- Thiotepa (10 mg/ml): 87.3 Minutes
- Vincristine Sulfate (1 mg/ml): >240 Minutes
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 20, 2021
Aspen Glove Sdn. Bhd. Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K213076
Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 18, 2021 Received: September 23, 2021
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.
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 Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213076
Device Name
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
K213076 510(K) SUMMARY As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION
| 510(K) Owner's Name | Aspen Glove Sdn. Bhd. |
|---|---|
| Address | Aspen House, 300, JLN Macalister, |
| 10450 Georgetown, Pulau Pinang, | |
| Malaysia | |
| Phone | +604- 227 5000 |
| Fax | +604- 227 5000 |
| corporate@aspen.com.my | |
| Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| Designation | Managing Director |
| Contact Number | 017-550 0577 |
| Contact Email | Iskandar@aspenglove.com.my |
| Date Submitted | 18 September 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free tested
for use with Chemotherapy drugs |
|-----------------------------------|---------------------------------------------------------------------------------------|
| Product proprietary or trade name | AspenMed+ |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty |
| Device Classification | Class- I |
| Product Code | LZA, LZC |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Harbour Health
Powder Free Nitrile Examination Glove, Blue (Tested for
use with Chemotherapy Drugs) |
|------------------|-----------------------------------------------------------------------------------------------------------|
| 510( K) Number | K210944 |
| Regulatory Class | I |
| Product code | LZA, LZC, OPJ |
D. DESCRIPTION OF THEDEVICE:
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I).
5
The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
E. INTENDED USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
| Tested Chemotherapy Drug Name &
Concentration | Minimum Breakthrough Detection
Time (Minutes) |
|--------------------------------------------------|--------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The tested chemotherapy drugs and their breakthrough detection times are as follows:
hat the following drugs have low permeation times Carmustine (BCNU) (3.3 mg/ml) 34.3 Minutes Thiotepa (10 mg/ml) 87.3 Minutes
Warning: Do not use with Carmustine (BCNU) & Thiotepa
6
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
|---|---|---|---|---|
| PREDICATE | PROPOSED | |||
| DEVICE | ||||
| 510(K) Number | K210944 | K213076 | ||
| Name of device | Harbour Health | |||
| Powder Free | ||||
| Nitrile | ||||
| Examination | ||||
| Glove, Blue | ||||
| (Tested for use | ||||
| with | ||||
| Chemotherapy | ||||
| Drugs) | Blue Nitrile | |||
| Examination Gloves | ||||
| Powder Free tested | ||||
| for use with | ||||
| Chemotherapy drugs | Similar | |||
| Product Code | LZA, LZC, OPJ | LZA, LZC | Similar | |
| Intended use | Harbour Health | |||
| Powder | ||||
| Free | ||||
| Nitrile | ||||
| Examination | ||||
| Glove, Blue | ||||
| (Tested for use | ||||
| with | ||||
| Chemotherapy | ||||
| Drugs) disposable | ||||
| device | ||||
| intended | ||||
| for | ||||
| medical | ||||
| purpose that is | ||||
| worn on the | ||||
| examiner's hand | ||||
| to | ||||
| prevent | ||||
| contamination | ||||
| between patient | ||||
| and examiner. | ||||
| The | ||||
| proposed | ||||
| device was tested | ||||
| for | ||||
| use | ||||
| with | ||||
| chemotherapy | ||||
| drugs as per | ||||
| ASTM D6978-05 | ||||
| (2019), Standard | ||||
| Practice | ||||
| for | ||||
| Assessment | ||||
| of | ||||
| Medical Gloves to | ||||
| Permeation by | ||||
| Chemotherapy | ||||
| Drugs | Blue Nitrile | |||
| Examination Gloves | ||||
| Powder Free tested | ||||
| for use with | ||||
| Chemotherapy drugs | ||||
| is a disposable | ||||
| device intended for | ||||
| medical purpose that | ||||
| is worn on the | ||||
| examiner's hand to | ||||
| prevent | ||||
| contamination | ||||
| between patient and | ||||
| examiner. | ||||
| Additionally, | ||||
| the | ||||
| gloves were tested | ||||
| for use with | ||||
| chemotherapy drugs | ||||
| in accordance with | ||||
| ASTM D6978-05 | ||||
| (2019) Standard | ||||
| Practice | ||||
| for | ||||
| Assessment | ||||
| of | ||||
| Medical Glove to | ||||
| Permeation by | ||||
| Chemotherapy | ||||
| Drugs. | Similar | |||
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | ||
| PREDICATE | ||||
| K210944 | DEVICE PERFORMANCE | |||
| PROPOSED | ||||
| DEVICE | REMARKS | |||
| Regulation Number | - | 21 CFR | ||
| 880.6250 | 21 CFR | |||
| 880.6250 | Same | |||
| Material | - | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D6319- | |||
| 2019 | Small, Large | |||
| Medium, Large, | ||||
| Extra | Small, Medium, | |||
| Large, Extra | ||||
| Large | Same | |||
| Single Use | Medical Glove | |||
| Guidance | ||||
| Manual |
- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Dimensions | ASTM D6319-
2019 | Length: Small-
Min 220 mm &
Medium, Large
& Extra large-
Min 230 mm
Width Min
95+/-10 mm(
Medium Size) | Length > 230
mm
Width Min
95+/-10 mm(for
medium size) | Similar |
| Physical Properties | ASTM D6319-
2019 | Before Ageing
Tensile Strength
min 14 Mpa
Ultimate
Elongation
Min 500%
After Ageing
Tensile Strength
min 14 Mpa
Ultimate
Elongation
Min 400% | Before Ageing
Tensile Strength
14 Mpa
Ultimate
Elongation
500%
After Ageing
Tensile Strength
14 Mpa
Ultimate
Elongation
400% | Same |
| Thickness | ASTM D6319-
2019 | Palm
min 0.05 mm
Finger
min 0.05 mm | Palm >0.05 mm
Finger > 0.05
mm | Same |
| Powder Free
Residue | ASTM D6319-
2019 | | No Data Available | Under the
conditions of the
study non
pyrogenic | ---- |
| | Acute Systemic Toxicity
Test ISO 10993-
11:2017(E) | Under the conditions
of the study, the
device does not
elicit a systemic
toxicity response in
the model animal | Under the condition
of study does not
induce any systemic
toxic concern | Similar |
| | Bacterial Endotoxin
test
USP 42 | No data available | 240 Minutes | Not Tested | Different |
| | Carmustine (BCNU) (3.3 mg/ml) | 14.5 Minutes | 34.3 Minutes | Different |
| | Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes | Same |
| | Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
| | Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes | >240 Minutes | Same |
| | Cytarabine (100 mg/ ml) | >240 Minutes | Not Tested | Different |
| | Dacarbazine (10.0 mg/ml) | >240 Minutes | >240 Minutes | Same |
| | Docetaxel (10 mg/ml) | >240 Minutes | Not Tested | Different |
| Doxorubicin HCl (2 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Etoposide (20 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Fluorouracil (50 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Ifosfamide (50 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Mechlorethamine HCL (1 mg/ml) | | >240 Minutes | Not Tested | Different |
| Methotrexate (25 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Mitomycin C (0.5 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| | Mitoxantrone (2 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Paclitaxel (6 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| | Thiotepa (10 mg/ml) | 47.4 Minutes | 87.3 Minutes | Different |
| Vincristine Sulfate (1 mg/ml) | | >240 Minutes | >240 Minutes | Same |
7
8
9
| G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------------- |
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 Standard | |||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application | To determine the | ||
| length of the gloves | Min 220 mm for Size Small | ||
| & Min 230 mm for all | |||
| other sizes | Small:- 245 mm | ||
| Medium:- 246 mm | |||
| Large:- 248 mm | |||
| X-Large:- 248 mm | |||
| ASTM D6319-2019 Standard | |||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application | To determine the | ||
| width of the gloves | Small:- 80+/-10 mm | ||
| Medium:- 95+/-10 mm | |||
| Large:- 110+/-10 mm | |||
| X-Large:- 120+/-10 mm | Small:- 80 mm | ||
| Medium:- 92 mm | |||
| Large:- 105 mm | |||
| X-Large:- 115 mm |
| 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 | ||||
| Small | |||||
| Medium | |||||
| Large | |||||
| X-Large | Palm | ||||
| 0.09 mm | |||||
| 0.09 mm | |||||
| 0.09 mm | |||||
| 0.09 mm | Finger | ||||
| 0.15mm | |||||
| 0.15mm | |||||
| 0.15mm | |||||
| 0.15mm | |||||
| ASTM D6319-2019 Standard | |||||
| Specification for Nitrile | |||||
| Examination Gloves for | |||||
| Medical Application | To Determine the | ||||
| physical | |||||
| properties- | |||||
| Tensile strength | Before Ageing | ||||
| Tensile Strength 14Mpa | |||||
| Min for all sizes | |||||
| After Ageing Tensile | |||||
| Strength 14Mpa | |||||
| Min | |||||
| for all sizes | Size | ||||
| Small | |||||
| Medium | |||||
| Large | |||||
| X-Large | Before | ||||
| ageing | |||||
| 18.52 Mpa | |||||
| 18.61 Mpa | |||||
| 18.67 Mpa | |||||
| 18.72 Mpa | After | ||||
| ageing | |||||
| 17.54 Mpa | |||||
| 17.68 Mpa | |||||
| 17.74 Mpa | |||||
| 17.80 Mpa | |||||
| 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 | ||||
| Small | |||||
| Medium | |||||
| Large | |||||
| X-Large | Before | ||||
| ageing | |||||
| 690% | |||||
| 693% | |||||
| 702% | |||||
| 705% | After | ||||
| ageing | |||||
| 665% | |||||
| 667% | |||||
| 669% | |||||
| 673% |
10
| 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 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
Small
Medium
Large
X-Large
Residual Powder
Content
0.21 mg/glove
0.22 mg/glove
0.22 mg/glove
0.22 mg/glove |
H. 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. |
11
Clinical Testing Summary I.
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
J. CONCLUSION
The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is as safe, as effective, and performs as well as the legally marketed predicate device Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) K210944.