(180 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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. 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.
This document describes the safety and efficacy of "Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K213408) by comparing its performance to a predicate device (K192954) and established ASTM standards. The study focuses on non-clinical testing, particularly the glove's resistance to permeation by chemotherapy drugs and fentanyl citrate.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this device are based on meeting or exceeding the minimum breakthrough detection times for various chemotherapy drugs and fentanyl citrate, as specified by ASTM D6978-05 (Reapproved 2019). Other criteria include physical properties, dimensions, watertight integrity, residual powder, and biocompatibility.
| Test Method / Characteristic | Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ASTM D412-16 | |||
| - Tensile Strength (Before aging) | Min 14 MPa | 14.4 MPa | Pass | |
| - Tensile Strength (After aging) | Min 14 MPa | 16.3 MPa | Pass | |
| - Ultimate Elongation (Before aging) | Min 500% | 506% | Pass | |
| - Ultimate Elongation (After aging) | Min 400% | 402% | Pass | |
| Dimension | ASTM D3767-03 | |||
| - Length | Min 240mm | Min 240mm | Pass | |
| - Width (XS) | 70 ± 10 mm | Ave = 72 mm | Pass | |
| - Width (S) | 80 ± 10 mm | Ave = 83 mm | Pass | |
| - Width (M) | 95 ± 10 mm | Ave = 95 mm | Pass | |
| - Width (L) | 110 ± 10 mm | Ave = 104 mm | Pass | |
| - Width (XL) | >110 mm | Ave = 115 mm | Pass | |
| - Thickness (Finger) | Min 0.05mm | 0.08mm | Pass | |
| - Thickness (Palm) | Min 0.05mm | 0.05mm | Pass | |
| Water Tight | ASTM D5151-19 | AQL 1.5 (Acceptance No: 14 for 500 samples) | 12 leaks found (within acceptance) | Pass |
| Residual Powder | ASTM D6124-06 | Less than 2 mg per glove | 1.5 mg/glove | Pass |
| Permeation by Chemotherapy Drugs | ASTM D6978-05 | ≥240mins (general) | ≥240mins (for most drugs) | Pass |
| - Carmustine (BCNU) 3.3mg/ml | No specific criterion for low BT | 22.5mins | (Noted as low permeation time, warnings issued) | |
| - Thio Tepa 10 mg/ml | No specific criterion for low BT | 36.1mins | (Noted as low permeation time, warnings issued) | |
| Fentanyl Citrate Permeation | ASTM D6978-05 | ≥240mins | >240mins | Pass |
| Biocompatibility | ||||
| - Primary Skin Irritation | ISO 10993-10:2010 | Not a primary skin irritant | Not a primary skin irritant (PII "0") | Pass |
| - Dermal Sensitization | ISO 10993-10:2010 | Not a contact sensitizer | Not a contact sensitizer | Pass |
| - Cytotoxicity - MEM Elution | ISO 10993-5:2009 | No cytotoxicity reactivity at certain extract concentrations | Severe cytotoxicity reactivity at 100%, 50%, and 25% extract concentrations; No cytotoxicity at 12.5%, 6.25%, and 3.125% extract concentrations | Not Pass (as it did not pass for 100%, 50% and 25% extract concentrations) |
| - Acute Systemic Toxicity | ISO 10993-11:2017 (E) | No adverse biological reaction | No adverse biological reaction | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical Properties (Tensile Strength, Elongation): Sample size not explicitly stated for individual tests, but implied to be sufficient for ASTM standards.
- Dimension: Sample size not explicitly stated.
- Water Tight: Sample size of 500 pieces (based on AQL level M for a batch of 500,001 or more).
- Residual Powder: Sample size of 5 pieces.
- Permeation by Chemotherapy Drugs and Fentanyl Citrate: Sample size not explicitly stated, but tests were performed per ASTM D6978-05.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): Sample sizes for the animal testing are not explicitly reported in this summary, but the results indicate standard testing procedures were followed.
- Data Provenance: The standard testing was conducted by Meditech Gloves Sdn Bhd, located in Malaysia. The study is a non-clinical study assessing the device's characteristics against recognized standards. It is implicitly a prospective evaluation for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This document describes non-clinical laboratory testing. There is no indication of human experts establishing "ground truth" for the test set in the way a clinical study would involve expert readers. The ground truth is defined by the objective measurement criteria within the ASTM and ISO standards used (e.g., specific permeation detection limits, physical property thresholds, AQL levels).
4. Adjudication Method for the Test Set:
Not applicable. This is a non-clinical device test where results are determined by objective measurements against established standard criteria, not by human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a patient examination glove, and the study focuses on its material and barrier properties, not on diagnostic accuracy involving human readers. Therefore, an MRMC study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical medical device (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for this study is based on predefined technical specifications and validated test methodologies outlined in international standards such as:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D6978-05 (Reapproved 2019) (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ASTM D412-16 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension)
- ASTM D3767-03(2020) (Standard Practice for Rubber—Measurement of Dimensions)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-11:2017 (E) (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
The performance of the gloves is directly measured against the quantitative and qualitative acceptance criteria specified in these standards.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through material and chemical barrier integrity tests.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 17, 2022
Meditech Gloves SDN BHD Wan Hassan Assistant Manager- OA/RA PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai, Negeri Sembilan 71800 Malaysia
Re: K213408
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: March 12, 2022 Received: March 22, 2022
Dear Wan Hassan:
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.
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
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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,
Bifeng Oian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213408
Device Name
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) tested for use with Chemotherapy Drugs and Fentanyl Citrate
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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Azacitidine. 25mg/ml (25,000 ppm) >240mins Bleomycin Sulphate 15mg/ml (15,000 ppm)>240mins Carboplatin 10mg/ml (10,000 ppm) >240mins Carmustine (BCNU) 3.3mg/ml (3300 ppm) 22.5mins Cetuximab 2mg/ml (2000 ppm) >240mins Cisplatin 1mg/ml (1000 ppm) >240mins Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm)>240mins Dacarbazine 10mg/ml (10,000 ppm)>240mins Docetaxel 10mg/ml (10,000 ppm) >240mins Doxorubicin HCl 2mg/ml (2,000 ppm) >240mins Ellence (Epirubicin) 2mg/ml (2,000 ppm) >240mins Etoposide 20mg/ml (20,000 ppm) >240mins Fluorouracil 50mg/ml (50.000 ppm) >240mins Gemcitabine 38mg/ml (38,000 ppm) >240mins Ifosfamide 50mg/ml (50,000 ppm) >240mins Irinotecan 20mg/ml (20,000 ppm) >240mins Methotrexate 25mg/ml (25,000ppm) >240mins Mitomycin C 0.5mg/ml (500 ppm) >240mins Mitoxantrone 2mg/ml (2,000 ppm) >240mins Oxaliplatin 2mg/ml (2,000ppm) >240mins Paclitaxel 6mg/ml (6,000 ppm) >240mins Rituximab 10mg/ml (10,000 ppm) >240mins Thio Tepa 10 mg/ml (10,000 ppm) 36.1 mins Vincristine Sulfate 1mg/ml 1,000 ppm) >240mins Vinorelbine 10mg/ml (10,000 ppm) >240mins Tested for Fentanyl Citrate is as follows: Fentanyl Citrate 100mcg/2ml >>240mins
Please note the following drugs have low permeation times Camustine (BCNU) 3.3mg/ml 22.5mins Thio Tepa 10mg/ml 36.1mins
Warning: Do not use these gloves with Camustine or Thio Tepa.
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Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 Submitter:
| Name: | Dr Effendi Tenang |
|---|---|
| Address: | Meditech Gloves Sdn BhdPT3345, Jalan Permata 1/3, Arab Malaysian Industrial Park,71800 Nilai, Negeri Sembilan, MALAYSIA |
| Phone No.: | +60 6 799 7742 |
| Fax No.: | +60 6 799 7749 |
Date of Summary Prepared: April 15, 2022
2.0 Name of the device:
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Common Name: Examination Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA, LZC, QDO)
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) K192954 : Class I Regulatory : LZA, LZC, QDO Product Code :
4.0 Description of The Device:
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber Inner surface of gloves undergoes surface treatment process to produce a latex. 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.
5.0 Intended Use of the Device:
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.
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Г
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
T
| Chemotherapy Drug and Concentration | MinimumBreakthroughDetection Time(Minutes) |
|---|---|
| Azacitidine, 25mg/ml (25,000 ppm) | >240mins |
| Bleomycin Sulphate 15mg/ml (15,000 ppm) | >240mins |
| Carboplatin 10mg/ml (10,000 ppm) | >240mins |
| Carmustine (BCNU) 3.3mg/ml (3300 ppm) | 22.5mins |
| Cetuximab 2mg/ml (2000 ppm) | >240mins |
| Cisplatin 1mg/ml (1000 ppm) | >240mins |
| Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm) | >240mins |
| Dacarbazine 10mg/ml (10,000 ppm) | >240mins |
| Docetaxel 10mg/ml (10,000 ppm) | >240mins |
| Doxorubicin HCl 2mg/ml (2,000 ppm) | >240mins |
| Ellence (Epirubicin) 2mg/ml (2,000 ppm) | >240mins |
| Etoposide 20mg/ml (20,000 ppm) | >240mins |
| Fluorouracil 50mg/ml (50,000 ppm) | >240mins |
| Gemcitabine 38mg/ml (38,000 ppm) | >240mins |
| Ifosfamide 50mg/ml (50,000 ppm) | >240mins |
| Irinotecan 20mg/ml (20,000 ppm) | >240mins |
| Methotrexate 25mg/ml (25,000ppm) | >240mins |
| Mitomycin C 0.5mg/ml (500 ppm) | >240mins |
| Mitoxantrone 2mg/ml (2,000 ppm) | >240mins |
| Oxaliplatin 2mg/ml (2,000ppm) | >240mins |
| Paclitaxel 6mg/ml (6,000 ppm) | >240mins |
| Rituximab 10mg/ml (10,000 ppm) | >240mins |
| Thio Tepa 10 mg/ml (10,000 ppm) | 36.1 mins |
| Vincristine Sulfate 1mg/ml 1,000 ppm) | >240mins |
| Vinorelbine 10mg/ml (10,000 ppm) | >240mins |
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Tested for Fentanyl Citrate is as follows:
Fentanyl Citrate 100mcg/2ml
240mins
Please note the following drugs have low permeation times Camustine (BCNU) 3.3mg/ml 22.5mins Thio Tepa 10mg/ml 36.1mins
Warning: Do not use these gloves with Camustine or Thio Tepa.
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6.0 Comparison of the Technological Characteristics with the Predicate Device:
The Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards of the subject gloves to the predicate device
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATEBLUE | CURRRENTBLUE | |||
| 510(k) Number | - | K192954 | K213408 | |
| Manufacturer(s) | - | Comfort Rubber GlovesIndustries Sdn. Bhd. | Meditech Gloves Sdn Bhd | |
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger textured | Finger textured | Same |
| Physical Properties | ASTM D6319-19 | Meets | Meets | Same |
| Thickness - Finger- Palm | ASTM D6319-19 | Min 0.05mmMin 0.05mm | 0.07- 0.10mm0.06- 0.09mm | Similar |
| Width | ASTM D6319-19 | XS Not ProvidedS Not ProvidedM Not ProvidedL Not ProvidedXL Not Provided | XS 70-75mmS 80-86mmM 93-97mmL 102-106mmXL 114-116mm | Different |
| XS 70±10mmS 80±10mmM 95±10mmL 110±10mmXL >110mm | ||||
| Length | ASTM D6319-19 | Min 240mm | Min 240mm | Same |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | COMPARISONANALYSIS | |
| PREDICATEBLUE | CURRRENTBLUE | |||
| Biocompatibility | Primary Skin Irritation -ISO 10993-10:2010 | PassesUnder the conditions of thestud, the subject device is non-irritating | Passes (Not a primary skinirritant)There was no erythema oroedema noted on test siteafter (1±0.1), (24±2),(48±2) and (72±2) hours.The primary Irritation Index(PII) was "0". Also, nomortality after 72 hours. Thegloves considerednegligible. | Similar |
| Biocompatibility | Dermal Sensitization- ISO10993-10:2010 | PassesUnder the conditions of thestud, the subject device is non-sensitizing | Passes (Not a contactsensitizer)There was no positiveallergic reaction observedduring the challenge phase(at 0, 24 hours and 48hours) in animals treatedwith the test material andnegative control. | Similar |
| Biocompatibility | Cytotoxicity - MEM Elution,ISO 10993-5:2009 | Exhibit severe cytotoxicityreactivity at 100% and 66%extract concentration and nocytotoxicity at 44%, 30%, 20%and 15% extract concentrationunder the condition of this test. | Exhibit severe cytotoxicityreactivity at 100%, 50%,and 25% extractconcentration.No cytotoxicity reactivity at12.5%, 6.25% and 3.125%extract concentrations. | Similar |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | COMPARISONANALYSIS | |
| PREDICATE | CURRENT | |||
| BLUE | BLUE | |||
| Biocompatibility | Acute Systemic Toxicity,ISO 10993-11:2017 (E) | PassesUnder the conditions of thestudy, the subject showed noadverse biological reaction. | Passes (no adverse biologicalreaction )No mortality was observed(72±2) hours | Same |
| Watertight (1000ml) | ASTM D6319-19 & ASTMD5151 | Passes at AQL 1.5 | Passes at AQL 1.5 | Same |
| Indication for Use | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination between patientand examiner. | A patient examination gloveis a disposable deviceintended for medical purposesthat is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer. | Same | |
| These gloves were tested foruse with chemotherapy drugsand Fentanyl Citrate per ASTMD6978-05 (Reapproved 2019)Standard Practice forAssessment of Medical Glovesto Permeation byChemotherapy Drugs. | These gloves were tested foruse with chemotherapy drugsand Fentanyl Citrate perASTM D6978-05 (Reapproved2019) Standard Practice forAssessment of Medical Glovesto Permeation byChemotherapy Drugs. | Same | ||
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | COMPARISON ANALYSIS | |
| PREDICATE | CURRENT | |||
| BLUE | BLUE | |||
| Chemotherapy Drugs Permeation Test ASTM D6978-05 (Reapproved 2019) | ||||
| Chemotherapy Drug andConcentration | ASTM D6978-05(Reapproved 2019) | Minimum Breakthrough Detection Time (Minutes) | ||
| Azacitidine, 25mg/ml(25,000 ppm) | - | >240mins | Different | |
| Bleomycin Sulphate15mg/ml (15,000 ppm) | - | >240mins | Different | |
| Carboplatin 10mg/ml(10,000 ppm) | - | >240mins | Different | |
| Carmustine (BCNU)3.3mg/ml (3300 ppm) | 18.32mins | 22.5mins | Similar | |
| Cetuximab 2mg/ml (2000ppm) | - | >240mins | Different | |
| Cisplatin 1mg/ml (1000ppm) | >240mins | >240mins | Same | |
| Cyclophosphamide(Cytoxan) 20mg/ml(20,000 ppm) | >240mins | >240mins | Same | |
| Dacarbazine 10mg/ml(10,000 ppm) | >240mins | >240mins | Same | |
| Docetaxel 10mg/ml (10,000ppm) | - | >240mins | Different | |
| Doxorubicin HCl 2mg/ml(2,000 ppm) | >240mins | >240mins | Same | |
| Ellence (Epirubicin) 2mg/ml(2,000 ppm) | - | >240mins | Different | |
| Etoposide 20mg/ml (20,000ppm) | >240mins | >240mins | Same | |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | COMPARISONANALYSIS | |
| PREDICATEBLUE | CURRENTBLUE | |||
| Fluorouracil 50mg/ml(50,000 ppm) | >240mins | >240mins | Same | |
| Gemcitabine 38mg/ml(38,000 ppm) | - | >240mins | Different | |
| Ifosfamide 50mg/ml(50,000 ppm) | >240mins | >240mins | Same | |
| Irinotecan 20mg/ml(20,000 ppm) | - | >240mins | Different | |
| Methotrexate 25mg/ml(25,000ppm) | >240mins | >240mins | Same | |
| Mitomycin C 0.5mg/ml (500ppm) | >240mins | >240mins | Same | |
| Mitoxantrone 2mg/ml(2,000 ppm) | >240mins | >240mins | Same | |
| Oxaliplatin 2mg/ml(2,000ppm) | - | >240mins | Different | |
| Paclitaxel 6mg/ml (6,000ppm) | >240mins | >240mins | Same | |
| Rituximab 10mg/ml(10,000 ppm) | - | >240mins | Different | |
| Thio Tepa 10 mg/ml(10,000 ppm) | 57.3mins | 36.1mins | Different | |
| Vincristine Sulfate 1mg/ml1,000 ppm) | >240mins | >240mins | Same | |
| Vinorelbine 10mg/ml(10,000 ppm) | - | >240mins | Different | |
| Warning | Do Not Use with Camustine | Do Not Use with Camustine orThio Tepa. | Different | |
| Fentanyl Citrate100mcg/2ml | >240mins | >240mins | Same | |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | COMPARISON ANALYSIS | |
| PREDICATE | CURRENT | |||
| BLUE | BLUE | |||
| Size | Medical Glove GuidanceManual - Labeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single Use | Medical Glove GuidanceManual – Labeling | Single use | Single use | Same |
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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods.
However, the current glove is tested to many more chemotherapy drugs than the predicate and has passed the minimum penetration time of 240 minutes.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical tests for this powder free nitrile patient examination gloves is summarized as per below.
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | |||||
| PhysicalProperties | ASTM D412-16(Standard Test Methodfor Vulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | TensileStrength | Min 14 MPa | Min 14 MPa | 14.4 | 16.3 | Pass |
| UltimateElongation | Min 500% | Min 400% | 506 | 402 | Pass |
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Dimension | ASTM D3767-03(2020) StandardPractice for Rubber –Measurement ofDimensions | To measure thelength, width, andthickness of glove | LengthWidth:XSSMLXLThickness | Min 240mmMin 240Ave = 72 mmAve = 83 mmAve = 95 mmAve = 104 mmAve = 115 mmThicknessFinger – 0.08mmPalm – 0.05mm | PassPassPassPassPassPassPass |
| Min 240mm70 ± 10 mm80 ± 10 mm95± 10 mm110 ± 10 mm>110Finger – 0.05mmPalm – 0.05mm |
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Water Tight | ASTM D 5151-19Standard Test Methodfor Detection of Holesin Medical Gloves | To detect holes thatleak water andthereby compromisethe usefulness of theglove | Sample Size : 500Inspection Level : GIAQL : 1.5Acceptance No : 14 | This batch sampling is 500,001and over. Hence according tosingle sampling plan GI, thesample to be drawn is under CodeM equivalent to 500 pieces withaccept 14 and reject 15.During the test, 12 pieces werefound with leaks. Hence it fallswithin the acceptance criteria. | Pass |
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124-06(2017) Standard TestMethod for ResidualPowder on MedicalGloves | To determine theamount of residualpowder and non-powder solids foundon gloves | Less than 2 mg per glove | Sample size : 5 pcsRequirement : <2mg/gloveResult : 1.5 mg/glove | Pass |
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
| Permeation byChemotherapyDrugs | ASTM D6978-05(2019) StandardPractice forAssessment of MedicalGloves to Permeationby ChemotherapyDrugs | To determine theminimumbreakthroughDetection Time | ≥240mins | ≥240minsExcept for Camustine andThio Tepa | Pass |
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
| BiocompatibilityPrimary SkinIrritation | ISO 10993-10:2010 | To demonstrates theirritation potential ofthe gloves, i.e., forinitiating or aggravatingdamage through itscontact with the skin | Not a primary skin irritantunder the condition of thistest. | Not a primary skin irritantThere was no erythema or oedemanoted on test site after $(1\pm0.1)$ ,$(24\pm2)$ , $(48\pm2)$ and $(72\pm2)$ hours.The primary Irritation Index (PII)was "0". Also, no mortality after 72hours. The gloves considerednegligible. | Pass |
| BiocompatibilityDermalSensitization | ISO 10993-10:2010 | To demonstrate thepotential of the devicefor eliciting a delayedhypersensitivity (TypeIV) immunologicresponse through itscontact with the skin. | Not a contact sensitizerunder the condition ofthis test. | Not a contact sensitizerThere was no positive allergicreaction observed during thechallenge phase (at 0, 24 hours and48 hours) in animals treated withthe test material and negativecontrol | Pass |
| BiocompatibilityCytotoxicity -MEM Elution | ISO 10993-5:2009 | To assess cytotoxicityreactivity caused bythis glove | At which level of extractconcentration, the gloveexhibits no cytotoxicityreactivity under thecondition of this test. | Exhibit severe cytotoxicity reactivityat 100%, 50%, and 25% extractconcentration.No cytotoxicity reactivity at12.5%, 6.25% and 3.125%extract concentrations | Not Pass |
| BiocompatibilityAcute SystemicToxicity | ISO 10993-11:2017 (E) | To demonstrateadverse effect occurringat any time within72hours after singleexposure | no adverse biologicalreaction under thecondition of this test. | no adverse biological reactionunder the condition of this test | Pass |
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Summary of Clinical Testing 8.0
Not applicable - Clinical data was not used to assess performance of the subject device.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Blue Colored, Powder Free Nitrile Examination Gloves, Nonsterile and tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954).
§ 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.