(87 days)
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.
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.
The provided text describes the acceptance criteria and performance of "Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl". This is a medical device, specifically examination gloves, and therefore the "study" concerns non-clinical performance testing rather than studies involving human participants or AI algorithms.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | |||
| Tensile Strength (Before aging) | ASTM D412 | Min 14.0 MPa | Pass |
| Ultimate Elongation (Before aging) | ASTM D412 | Min 500% | Pass |
| Tensile Strength (After aging) | ASTM D412 | Min 14.0 MPa | Pass |
| Ultimate Elongation (After aging) | ASTM D412 | Min 400% | Pass |
| Dimension | |||
| Length (Small) | ASTM D3767 | Min 220 mm | Pass |
| Length (Medium) | ASTM D3767 | Min 230 mm | Pass |
| Length (Large) | ASTM D3767 | Min 230 mm | Pass |
| Length (Extra Large) | ASTM D3767 | Min 230 mm | Pass |
| Length (Double Extra Large) | ASTM D3767 | Min 230 mm | Pass |
| Width (Small) | ASTM D3767 | 80 $\pm$ 10 mm | Pass |
| Width (Medium) | ASTM D3767 | 95 $\pm$ 10 mm | Pass |
| Width (Large) | ASTM D3767 | 110 $\pm$ 10 mm | Pass |
| Width (Extra Large) | ASTM D3767 | 120 $\pm$ 10 mm | Pass |
| Width (Double Extra Large) | ASTM D3767 | 130 $\pm$ 10 mm | Pass |
| Thickness (Finger) | ASTM D3767 | Min 0.05 mm | Pass |
| Thickness (Palm) | ASTM D3767 | Min 0.05 mm | Pass |
| Watertight | |||
| Hole Detection (All sizes listed) | ASTM D5151 | AQL: 1.5 | Found 0 (Pass) for all sizes |
| Residual Powder | ASTM D6124 | Less than 2.0 mg per glove | Pass |
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 (E) | Not an irritant | Pass |
| Dermal Sensitization | ISO 10993-10 (E) | Not a sensitizer | Pass |
| Acute Systemic Toxicity | ISO 10993-11 (E) | No acute systemic toxicity | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 | ||
| Carmustine (BCNU) (3.3 mg/ml) | Minimum breakthrough time >240 min (general criteria listed) | 44.5 min (explicitly stated in the table, with warning that it is low) | |
| Cisplatin (1.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Cyclophosphamide (20.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Dacarbazine (10.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Doxorubicin HCl (2.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Etoposide (20.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Fluorouracil (50.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Ifosfamide (50.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Methotrexate (25.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Mitoxantrone HCl (2.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Paclitaxel (6.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| ThioTepa (10.0 mg/ml) | Minimum breakthrough time >240 min (general criteria listed) | 79.1 min (explicitly stated in the table, with warning that it is low) | |
| Vincristine Sulfate (1.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Fentanyl Citrate (50 mcg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Shelf Life | ASTM D7160 | 3 years (based on accelerated aging) | Established 3 years |
2. Sample size used for the test set and the data provenance:
- For Watertightness (ASTM D5151):
- Small: 200 pcs
- Medium: 315 pcs
- Large: 315 pcs
- Extra Large: 315 pcs
- Double Extra Large: 200 pcs
- For other tests (Physical Properties, Dimension, Residual Powder, Biocompatibility, Chemotherapy Drug and Fentanyl Citrate Permeation): The specific sample sizes are not explicitly stated in the provided text. However, for these types of non-clinical tests, samples are typically drawn from manufacturing lots according to the requirements of the respective ASTM or ISO standards.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It is a report of completed non-clinical performance and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The document describes the performance of a physical medical device (gloves) through standardized non-clinical laboratory testing (e.g., tensile strength, chemical permeation) to establish its physical and chemical properties and safety. There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices or AI algorithms, to resolve discrepancies in human expert interpretations or to establish a consensus ground truth. This document pertains to non-clinical laboratory testing of a tangible product.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a physical examination glove, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and there is no AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical examination glove, not an algorithm, so there is no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by the accepted methodologies and metrics defined in the referenced ASTM and ISO standards for physical, chemical, and biocompatibility testing. For example:
- Physical properties (tensile strength, elongation) are measured objectively using a Tensile Testing Machine.
- Dimension (length, width, thickness) is measured using appropriate measurement tools.
- Watertightness is determined objectively by inspecting for holes after filling with water.
- Chemical permeation is physically measured based on the detection time of breakthrough.
- Biocompatibility is assessed through standardized in-vitro or in-vivo (animal) tests specified by ISO 10993 standards.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense of a diagnostic or therapeutic device for this type of product.
8. The sample size for the training set:
This is not applicable. The device is a physical product, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for a physical product.
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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.
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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.
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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 SalakTinggi, 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 DrugsAnd 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 ExaminationGloves, Non-sterile, Tested For Use With ChemotherapyDrugs |
| 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, TexturedFingertips, Powder-Free, Non-sterile, Ambidextrous,Beaded Cuff, Medical Examination Gloves, Tested for Usewith Opioids Fentanyl citrate, Heroin, and both Opioids insimulated Gastric Acid (Vomit) |
| Regulation Number | 21 CFR 880.6250 |
| 510(k) Number | K220375 |
| Regulatory Class | I |
| Product Code | LZA, QDO |
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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 | BreakthroughDetection 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 |
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| 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 DetectionTime in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 50mcg/mL | No breakthrough up to 240minutes |
7.0 Comparison of Technological Characteristics Between the Subject Device and Predicate Device:
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Table 1
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISONANALYSIS |
|---|---|---|---|---|---|
| 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: WhiteInner: Green | Outer: WhiteInner: Green | Same withreference device |
| Texture | - | Finger Textured | Finger textured | Finger textured | Same |
| Physical Properties | ASTM D6319 | Meets | Meets | Meets | Same |
| Before AgingTensile Strength:Ultimate Elongation: | - | 14Mpa min500% min | 30 ± 0.03 Mpa600% min | 14MPa min500% min | Same |
| After AgingTensile Strength:Ultimate Elongation: | - | 14Mpa min400% min | 32 ± 0.03 Mpa550% | 14Mpa min400% min | Same |
| Thickness:- Finger- Palm | ASTM D6319 | Meets0.07 - 0.10mm0.07 – 0.09mm | Meets0.21 ± 0.03 mm0.16 ± 0.03 mm | Meets0.20 ± 0.03 mm0.16 ± 0.03 mm | Different butwithin the ASTMstandard |
| Powder Free | ASTM D6124 | Less than 2mg perglove | Less than 2mg perglove | Less than 2mg perglove | Same |
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISONANALYSIS |
| Biocompatibility | Primary SkinIrritation - ISO10993-10:2010(E) | PassesNot a primary skinirritant under theconditions of the study | PassesNot a primary skinirritant under theconditions of the study | PassesNot a primary skinirritant under theconditions of the study | Same |
| DermalSensitization-ISO 10993-10:2010 (E) | PassesNot a contact sensitizerunder the conditions ofthe study. | PassesNot a contactsensitizer under theconditions of thestudy. | PassesNot a contactsensitizer under theconditions of thestudy. | Same | |
| Acute SystemicToxicity, ISO10993-11:2017(E) | PassesIt is concluded that theproduct did not induceany systemic toxicity. | PassesIt is concluded thatthe product did notinduce any systemictoxicity. | PassesIt is concluded thatthe product did notinduce any systemictoxicity. | Same | |
| Watertight(1000ml) | ASTM D5151 | Inspection Level 1, AQL1.5 | 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 examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. | Same |
| Size | Medical GloveGuidance Manual– Labeling | Extra SmallSmallMediumLargeExtra Large | SmallMediumLargeExtra LargeDouble Extra LargeTriple Extra Large | SmallMediumLargeExtra LargeDouble Extra Large | Similar |
| Single use | Medical GloveGuidance Manual- Labeling | Single use | Single use | Single use | Same |
| Sterility status | Medical GloveGuidance Manual– Labeling | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf life | ASTM D7160 | 5 years | 3 years | Different | |
| ChemotherapyDrug PermeationTest | 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 |
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| 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 |
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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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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | |||
|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | ||||
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanizedRubber andThermoplasticElastomers-Tension) | Toevaluatethe tensile(tension)propertiesof glove. | Tensilestrength | Min 14.0MPa | Min 14.0MPa | Pass | Pass |
| Ultimateelongation | Min 500% | Min 400% | Pass | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D3767Standard Practicefor Rubber -Measurement ofDimensions | To measurethe length,width, andthickness ofglove | LengthSmall - Min 220 mmMedium - Min 230 mmLarge - Min 230 mmExtra Large - Min 230 mmDouble Extra Large - Min 230 mm | Pass |
| WidthSmall - 80 $\pm$ 10 mmMedium - 95 $\pm$ 10 mmLarge - 110 $\pm$ 10 mmExtra Large - 120 $\pm$ 10 mmDouble Extra Large - 130 $\pm$ 10 mm | Pass |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D3767Standard Practicefor Rubber -Measurement ofDimensions | To measurethe length,width, andthickness ofglove | ThicknessFinger – min 0.05mmPalm – min 0.05mm | Pass |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results |
|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves) | To detect holes thatleak water andthereby compromisethe usefulness of theglove | Size: SmallSample size: 200 pcsInspection level: GIAQL: 1.5, Acceptance No. 7,Found 0 | Pass |
| Size: MediumSample size: 315 pcsInspection level: GIAQL: 1.5, Acceptance No. 10,Found 0 | Pass | |||
| Size: LargeSample size: 315 pcsInspection level: GIAQL: 1.5, Acceptance No. 10,Found 0 | Pass | |||
| Size: Extra LargeSample size: 315 pcsInspection level: GIAQL: 1.5, Acceptance No. 10,Found 0 | Pass | |||
| Size: Double Extra LargeSample size: 200 pcsInspection level: GIAQL: 1.5, Acceptance No. 7,Found 0 | Pass |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results |
|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod forResidual Powderon Medical Gloves) | To determine theamount of residualpowder and non-powder solids foundon gloves | Have a powder residue limit of 2.0 mg perglove | Pass |
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|---|
| Biocompatibility | Primary SkinIrritation - ISO10993-10 (E) | To assess the potentialof glove to producedermal irritation | Under the conditions of the study, notan irritant | Pass |
| Biocompatibility | DermalSensitization- ISO10993-10 (E) | To assess the potentialof glove to causedermal sensitization | Under the conditions of the study, nota sensitizer | Pass |
| Biocompatibility | Acute SystemicToxicity, ISO10993-11 (E) | To determine the acutesystemic toxicitypotential of glove | Under the conditions of the study, noacute systemic toxicity | Pass |
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| Test Method | Standard | Purpose ofTesting | Acceptance Criteria | Results | |
|---|---|---|---|---|---|
| ChemotherapyDrug and FentanylCitratePermeation | ASTM D6978-05(Assessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs) | To assess theresistance ofmedical glovematerials topermeation bychemotherapydrugs andfentanylcitrate | Minimumbreakthrough time>240min | Carmustine 3.3 mg/mlCisplatin 1 mg/mlCyclophosphamide 20 mg/mlDacarbazine 10 mg/mlDoxorubicin HCI 2 mg/mlEtoposide 20 mg/mlFluorouracil 50 mg/mlIfosfamide 50 mg/mlMethotrexate 25 mg/mlMitoxantrone HCI 2 mg/mlPaclitaxel 6 mg/mlThiotepa 10 mg/mlVincristine Sulfate 1 mg/mlFentanyl 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 min79.1 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.
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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.
§ 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.