(87 days)
No
The device description and performance studies focus solely on the physical and chemical properties of examination gloves, with no mention of AI or ML.
No
The device is a patient examination glove used to prevent contamination between patient and examiner, not to treat a medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
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 is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures.
- Device Description: The description details the physical characteristics and materials of a glove.
- Performance Studies: The performance studies focus on the physical properties of the glove, its ability to prevent leakage, biocompatibility, and resistance to drug permeation. These are all relevant to a barrier device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide information about a patient's health status, which is the core function of an IVD.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This glove is used in vivo (on the body) as a protective barrier.
N/A
Intended Use / Indications for Use
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration Average Breakthrough Detection Time (Minutes |
|---|---|
| *Carmustine (BCNU) (3.3 mg/ml) | 44.5 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (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 (6.0 mg/ml) | > 240 |
| *ThioTepa (10.0 mg/ml) | 79.1 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
- WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 44.5 minutes and Thiotepa: 79.1 minutes. Do not use with Carmustine and Thiotepa.
| Opioid Drug | Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (50 mcg/ml) | No breakthrough up to 240 minutes |
Product codes
LZA, LZC, OPJ, QDO
Device Description
Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl meets all requirements of ASTM standard D6319-19.
The powder free examination glove is manufactured from synthetic rubber nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319. Device is intended for single use and nonsterile.
The powder free examination glove, non-sterile is supplied in the following sizes: S, M, L, XL and XXL. This glove is green (inner) and white (outer) in color and powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger (worn on the examiner's hand or finger)
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
Non-clinical testing was performed as summarized below:
Physical Properties
- Study Type: Performance Test (Tensile Properties)
- Method: ASTM D412
- Purpose: To evaluate the tensile (tension) properties of glove.
- Acceptance Criteria:
- Before aging: Tensile strength Min 14.0 MPa, Ultimate elongation Min 500%
- After aging: Tensile strength Min 14.0 MPa, Ultimate elongation Min 400%
- Results: Pass for both before and after aging.
Dimension
- Study Type: Performance Test (Length, Width, Thickness)
- Method: ASTM D3767
- Purpose: To measure the length, width, and thickness of glove.
- Acceptance Criteria:
- Length: Small - Min 220 mm, Medium - Min 230 mm, Large - Min 230 mm, Extra Large - Min 230 mm, Double Extra Large - Min 230 mm
- Width: Small - 80 ± 10 mm, Medium - 95 ± 10 mm, Large - 110 ± 10 mm, Extra Large - 120 ± 10 mm, Double Extra Large - 130 ± 10 mm
- Thickness: Finger – min 0.05mm, Palm – min 0.05mm
- Results: Pass for all dimensions.
Watertight
- Study Type: Performance Test (Detection of Holes)
- Method: ASTM D5151
- Purpose: To detect holes that leak water and thereby compromise the usefulness of the glove.
- Sample Size:
- Small: 200 pcs
- Medium: 315 pcs
- Large: 315 pcs
- Extra Large: 315 pcs
- Double Extra Large: 200 pcs
- Acceptance Criteria: Inspection level: GI, AQL: 1.5, Acceptance No. 7 (for Small and Double Extra Large), Acceptance No. 10 (for Medium, Large, Extra Large).
- Results: Found 0 holes for all sizes, hence Passed.
Residual Powder
- Study Type: Performance Test
- Method: ASTM D6124
- Purpose: To determine the amount of residual powder and non-powder solids found on gloves.
- Acceptance Criteria: Have a powder residue limit of 2.0 mg per glove.
- Results: Pass.
Biocompatibility
- Study Type: Performance Test
- Methods:
- Primary Skin Irritation - ISO 10993-10 (E)
- Dermal Sensitization - ISO 10993-10 (E)
- Acute Systemic Toxicity, ISO 10993-11 (E)
- Purpose: To assess the potential of glove to produce dermal irritation, to cause dermal sensitization, and to determine the acute systemic toxicity potential of glove.
- Acceptance Criteria:
- Not an irritant under the conditions of the study
- Not a sensitizer under the conditions of the study
- No acute systemic toxicity under the conditions of the study
- Results: Pass for all biocompatibility tests.
Chemotherapy Drug and Fentanyl Citrate Permeation
- Study Type: Performance Test
- Method: ASTM D6978-05
- Purpose: To assess the resistance of medical glove materials to permeation by chemotherapy drugs and fentanyl citrate.
- Acceptance Criteria: Minimum breakthrough time >240min (except for Carmustine and ThioTepa which have warning notes indicating lower permeation times).
- Results:
- Carmustine 3.3 mg/ml: 44.5 min
- Cisplatin 1 mg/ml: >240 min
- Cyclophosphamide 20 mg/ml: >240 min
- Dacarbazine 10 mg/ml: >240 min
- Doxorubicin HCI 2 mg/ml: >240 min
- Etoposide 20 mg/ml: >240 min
- Fluorouracil 50 mg/ml: >240 min
- Ifosfamide 50 mg/ml: >240 min
- Methotrexate 25 mg/ml: >240 min
- Mitoxantrone HCI 2 mg/ml: >240 min
- Paclitaxel 6 mg/ml: >240 min
- Thiotepa 10 mg/ml: 79.1 min
- Vincristine Sulfate 1 mg/ml: >240 min
- Fentanyl Citrate 50 mcg/ml: >240 min
Shelf-life Study
- Study Type: Accelerated Aging Study
- Method: ASTM D7160
- Purpose: To establish a 3 years shelf life based on visual appearance, hole defect and physical properties for establishing a 3 years shelf life.
- Results: Claimed to describe the effect of accelerated aging and support a 3-year shelf life.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 17, 2023
WRP Asia Pacific Sdn. Bhd. Muhammad Ameer Arief Mohd Mujab Regulatory Affairs Executive Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang. Selangor 43900 Malaysia
Re: K232538
Trade/Device Name: Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: August 1, 2023 Received: August 22, 2023
Dear Muhammad Ameer Arief Mohd Mujab:
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 (the 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 available 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
K232538 - Muhammad Ameer Arief Mohd Mujab
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Allah G
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control
2
and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232538
Device Name
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
Indications for Use (Describe)
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration Average Breakthrough Detection Time (Minutes |
|---|---|
| *Carmustine (BCNU) (3.3 mg/ml) | 44.5 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (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 (6.0 mg/ml) | > 240 |
| *ThioTepa (10.0 mg/ml) | 79.1 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
- WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 44.5 minutes and Thiotepa: 79.1 minutes. Do not use with Carmustine and Thiotepa.
| Opioid Drug | Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (50 mcg/ml) | No breakthrough up to 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.
4
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5
1.0 Submitter:
| Sponsor: | WRP Asia Pacific Sdn. Bhd. |
|---|---|
| Contact Name: | Muhammad Ameer Arief bin Mohd Mujab |
| Address: | WRP Asia Pacific Sdn. Bhd. |
| Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak | |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 17 November 2023
2.0 Identification of the subject device:
| Trade Name | : Dual Color Nitrile Examination Gloves, Powder Free,
Non-Sterile, Tested For Use With Chemotherapy Drugs
And Fentanyl |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : I |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA, LZC, OPJ, ODO |
3.0 Predicate Device:
| PREDICATE DEVICE | |
|---|---|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device Name | Dermagrip Powder Free Blue Nitrile Patient Examination |
| Gloves, Non-sterile, Tested For Use With Chemotherapy | |
| Drugs | |
| Regulation Number | 21 CFR 880.6250 |
| 510 (k) Number | K161422 |
| Regulatory Class | I |
| Product Code | LZA, LZC |
4.0 Reference Device:
| REFERENCE DEVICE | |
|---|---|
| Manufacturer | Summit Glove, Inc |
| Device name | Intercept Free, Nitrile Two Toned White/Green, Textured |
| Fingertips, Powder-Free, Non-sterile, Ambidextrous, | |
| Beaded Cuff, Medical Examination Gloves, Tested for Use | |
| with Opioids Fentanyl citrate, Heroin, and both Opioids in | |
| simulated Gastric Acid (Vomit) | |
| Regulation Number | 21 CFR 880.6250 |
| 510(k) Number | K220375 |
| Regulatory Class | I |
| Product Code | LZA, QDO |
6
5.0 Description of The Device:
Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl meets all requirements of ASTM standard D6319-19.
The powder free examination glove is manufactured from synthetic rubber nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319. Device is intended for single use and nonsterile.
The powder free examination glove, non-sterile is supplied in the following sizes: S, M, L, XL and XXL. This glove is green (inner) and white (outer) in color and powder free.
6.0 Indication for use:
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration | Breakthrough
Detection Time
(Minutes) |
|----------------------------|---------------|---------------------------------------------|
| *Carmustine (BCNU) | 3.3 mg/ml | 44.5 |
| Cisplatin | 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 |
| Dacarbazine | 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 |
7
| Mitoxantrone | 2.0 mg/ml | > 240 |
|---|---|---|
| Paclitaxel | 6.0 mg/ml | > 240 |
| *ThioTepa | 10.0 mg/ml | 79.1 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 44.5 minutes and Thiotepa: 79.1 minutes. Do not use with Carmustine and Thiotepa.
| Opioid Drug | Concentration | Breakthrough Detection
Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 50mcg/mL | No breakthrough up to 240
minutes |
7.0 Comparison of Technological Characteristics Between the Subject Device and Predicate Device:
8
Table 1
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON
ANALYSIS |
|-----------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 510(k) Number | - | K161422 | K220375 | K232538 | - |
| Manufacturer(s) | - | WRP Asia Pacific | Summit Glove, Inc | WRP Asia Pacific | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Nitrile | Same |
| Color | - | Blue | Outer: White
Inner: Green | Outer: White
Inner: Green | Same with
reference device |
| Texture | - | Finger Textured | Finger textured | Finger textured | Same |
| Physical Properties | ASTM D6319 | Meets | Meets | Meets | Same |
| Before Aging
Tensile Strength:
Ultimate Elongation: | - | 14Mpa min
500% min | 30 ± 0.03 Mpa
600% min | 14MPa min
500% min | Same |
| After Aging
Tensile Strength:
Ultimate Elongation: | - | 14Mpa min
400% min | 32 ± 0.03 Mpa
550% | 14Mpa min
400% min | Same |
| Thickness:
- Finger
- Palm | ASTM D6319 | Meets
0.07 - 0.10mm
0.07 – 0.09mm | Meets
0.21 ± 0.03 mm
0.16 ± 0.03 mm | Meets
0.20 ± 0.03 mm
0.16 ± 0.03 mm | Different but
within the ASTM
standard |
| Powder Free | ASTM D6124 | Less than 2mg per
glove | Less than 2mg per
glove | Less than 2mg per
glove | Same |
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON
ANALYSIS |
| Biocompatibility | Primary Skin
Irritation - ISO
10993-10:2010
(E) | Passes
Not a primary skin
irritant under the
conditions of the study | Passes
Not a primary skin
irritant under the
conditions of the study | Passes
Not a primary skin
irritant under the
conditions of the study | Same |
| | Dermal
Sensitization-
ISO 10993-10:
2010 (E) | Passes
Not a contact sensitizer
under the conditions of
the study. | Passes
Not a contact
sensitizer under the
conditions of the
study. | Passes
Not a contact
sensitizer under the
conditions of the
study. | Same |
| | Acute Systemic
Toxicity, ISO
10993-11:2017
(E) | Passes
It is concluded that the
product did not induce
any systemic toxicity. | Passes
It is concluded that
the product did not
induce any systemic
toxicity. | Passes
It is concluded that
the product did not
induce any systemic
toxicity. | Same |
| Watertight
(1000ml) | ASTM D5151 | Inspection Level 1, AQL
1.5 | Inspection Level 1,
AQL 0.65 | Inspection Level 1,
AQL 1.5 | Similar |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | COMPARISON ANALYSIS |
| | | PREDICATE | REFERENCE | CURRENT | |
| Intended use | - | 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. | 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. | 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. | Same |
| Size | Medical Glove
Guidance Manual
– Labeling | Extra Small
Small
Medium
Large
Extra Large | Small
Medium
Large
Extra Large
Double Extra Large
Triple Extra Large | Small
Medium
Large
Extra Large
Double Extra Large | Similar |
| Single use | Medical Glove
Guidance Manual - Labeling | Single use | Single use | Single use | Same |
| Sterility status | Medical Glove
Guidance Manual
– Labeling | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf life | ASTM D7160 | | 5 years | 3 years | Different |
| Chemotherapy
Drug Permeation
Test | ASTM D6978-
05 | Minimum Breakthrough Detection Time (Minutes) | | | |
| * Carmustine
(BCNU)
(3.3 mg/ml) | | 15.0 | N/A | 44.5 | Similar |
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS |
| Cisplatin (1.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Dacarbazine (10.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Etoposide (20.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Fluorouracil (50.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Ifosfamide (50.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Methotrexate (25.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Mitomycin C (0.5 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Mitoxantrone (2.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Paclitaxel (6.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| * ThioTepa (10.0 mg/ml) | 2.0 | 2.0 | N/A | 79.1 | Similar |
| Vincristine Sulfate (1.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
9
10
11
12
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS |
|---|---|---|---|---|---|
| Warning Statement | WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 15.0 minutes and Thiotepa: 2.0 | N/A | WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 44.5 minutes and Thiotepa: 79.1 minutes. Do not use with Carmustine and Thiotepa. | Similar | |
| Fentanyl Citrate | N/A | > 240 | > 240 | Same with reference device | |
| Fentanyl + Heroin | N/A | > 240 | N/A | Different | |
| Fentanyl + Heroin in simulated Gastric Acid Mix | N/A | > 240 | N/A | Different |
13
There are no significant differences between the devices. Both devices have been tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05.
They are slightly different in thickness; whereby the current device is thicker than the predicate device. Predicate device comes in blue color whereas the subject device comes in a combination of fluoresced green (inner part) and white (outer part) color. Other differences noted, subject device was tested for Fentanyl Citrate which accords to ASTM D6978-05.
8.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test for this Glove are summarized as per below.
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| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | | Results | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------|-----------------|-----------------|-------------|------|
| | | | Before aging | After aging | Before aging | After aging | |
| Physical
Properties | ASTM D412
(Standard Test
Method for
Vulcanized
Rubber and
Thermoplastic
Elastomers-
Tension) | To
evaluate
the tensile
(tension)
properties
of glove. | Tensile
strength | Min 14.0
MPa | Min 14.0
MPa | Pass | Pass |
| | | | Ultimate
elongation | Min 500% | Min 400% | Pass | Pass |
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results |
|----------------|---------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimension | ASTM D3767
Standard Practice
for Rubber -
Measurement of
Dimensions | To measure
the length,
width, and
thickness of
glove | Length
Small - Min 220 mm
Medium - Min 230 mm
Large - Min 230 mm
Extra Large - Min 230 mm
Double Extra Large - Min 230 mm | Pass |
| | | | Width
Small - 80 $\pm$ 10 mm
Medium - 95 $\pm$ 10 mm
Large - 110 $\pm$ 10 mm
Extra Large - 120 $\pm$ 10 mm
Double Extra Large - 130 $\pm$ 10 mm | Pass |
15
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results |
|----------------|---------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------|---------|
| Dimension | ASTM D3767
Standard Practice
for Rubber -
Measurement of
Dimensions | To measure
the length,
width, and
thickness of
glove | Thickness
Finger – min 0.05mm
Palm – min 0.05mm | Pass |
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| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results |
|----------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------|
| Watertight | ASTM D5151
(Standard Test
Method for
Detection of Holes
in Medical Gloves) | To detect holes that
leak water and
thereby compromise
the usefulness of the
glove | Size: Small
Sample size: 200 pcs
Inspection level: GI
AQL: 1.5, Acceptance No. 7,
Found 0 | Pass |
| | | | Size: Medium
Sample size: 315 pcs
Inspection level: GI
AQL: 1.5, Acceptance No. 10,
Found 0 | Pass |
| | | | Size: Large
Sample size: 315 pcs
Inspection level: GI
AQL: 1.5, Acceptance No. 10,
Found 0 | Pass |
| | | | Size: Extra Large
Sample size: 315 pcs
Inspection level: GI
AQL: 1.5, Acceptance No. 10,
Found 0 | Pass |
| | | | Size: Double Extra Large
Sample size: 200 pcs
Inspection level: GI
AQL: 1.5, Acceptance No. 7,
Found 0 | Pass |
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| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results |
|--------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------|---------|
| Residual
Powder | ASTM D6124
(Standard Test
Method for
Residual Powder
on Medical Gloves) | To determine the
amount of residual
powder and non-
powder solids found
on gloves | Have a powder residue limit of 2.0 mg per
glove | Pass |
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|---|
| Biocompatibility | Primary Skin | |||
| Irritation - ISO | ||||
| 10993-10 (E) | To assess the potential | |||
| of glove to produce | ||||
| dermal irritation | Under the conditions of the study, not | |||
| an irritant | Pass | |||
| Biocompatibility | Dermal | |||
| Sensitization- ISO | ||||
| 10993-10 (E) | To assess the potential | |||
| of glove to cause | ||||
| dermal sensitization | Under the conditions of the study, not | |||
| a sensitizer | Pass | |||
| Biocompatibility | Acute Systemic | |||
| Toxicity, ISO | ||||
| 10993-11 (E) | To determine the acute | |||
| systemic toxicity | ||||
| potential of glove | Under the conditions of the study, no | |||
| acute systemic toxicity | Pass |
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| Test Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemotherapy
Drug and Fentanyl
Citrate
Permeation | ASTM D6978-05
(Assessment of
Resistance of
Medical Gloves to
Permeation by
Chemotherapy
Drugs) | To assess the
resistance of
medical glove
materials to
permeation by
chemotherapy
drugs and
fentanyl
citrate | Minimum
breakthrough time
240min | Carmustine 3.3 mg/ml
Cisplatin 1 mg/ml
Cyclophosphamide 20 mg/ml
Dacarbazine 10 mg/ml
Doxorubicin HCI 2 mg/ml
Etoposide 20 mg/ml
Fluorouracil 50 mg/ml
Ifosfamide 50 mg/ml
Methotrexate 25 mg/ml
Mitoxantrone HCI 2 mg/ml
Paclitaxel 6 mg/ml
Thiotepa 10 mg/ml
Vincristine Sulfate 1 mg/ml
Fentanyl Citrate 50 mcg/ml | 44.5 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
79.1 min
240 min
240 min |
The shelf-life study claim of this Glove describes the effect of accelerated aging on visual appearance, hole defect and physical properties for establishing a 3 years shelf life based on ASTM D7160.
19
9.0 Summary of Clinical Testing:
No clinical study is included in this submission.
10.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl is as safe, as effective, and performs as well as or better than the legally marketed predicate device K161422.