(73 days)
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Bleomycin Sulfate (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml)
Docetaxel (10.0 mg/ml)
Doxorubicin HCl (2.0 mg/ml)
Epirubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (38.0 mg/ml)
Idarubicin HCl (1.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Irinotecan (20.0 mg/ml)
Mechlorethamine HCl (1.0 mg/ml)
Melphalan (5.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCl (2.0 mg/ml)
Paclitaxel (6.0 mg/ml)
Rituximab (10.0 mg/ml)
Trisenox (1.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes
Warning: Not for Use with: Carmustine, Thiotepa
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) with sizes Medium, Large, X-Large and XX-Large are included in the submission.
The provided text describes the acceptance criteria and performance of the Nephron Nitrile Powder-Free Nitrile Examination Gloves.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 (Dimensions - Length) | To determine the length of the gloves | Medium: 230 mm minLarge: 230 mm minX-Large: 230 mm minXX-Large: 230 mm min | Medium: 235 mmLarge: 237 mmX-Large: 250 mmXX-Large: 238 mm |
| ASTM D6319-19 (Dimensions - Width) | To determine the width of the gloves | Medium: 95+/-10 mmLarge: 110+/-10 mmX-Large: 120+/-10 mmXX-Large: 130+/-10 mm | Medium: 95 mmLarge: 113 mmX-Large: 121 mmXX-Large: 129 mm |
| ASTM D6319-19 (Thickness) | To determine the thickness of the gloves | Palm: 0.05 mm min for all sizesFinger: 0.05 mm min for all sizes | Size Palm (Avg value) Finger (Avg value)Medium 0.077 mm 0.111 mmLarge 0.106 mm 0.109 mmX-Large 0.089 mm 0.115 mmXX-Large 0.113 mm 0.107 mm |
| ASTM D6319-19 (Physical Properties - Tensile Strength) | To determine the physical properties - Tensile strength | Before Ageing Tensile Strength: 14MPa min for all sizesAfter Ageing Tensile Strength: 14MPa min for all sizes | Size Before ageing After ageingMedium 34.0 MPa 37.3 MPa |
| ASTM D6319-19 (Physical Properties - Ultimate Elongation) | To determine the physical properties - Ultimate Elongation | Before Ageing Ultimate Elongation: 500% min for all sizesAfter Ageing Ultimate Elongation: 400% min for all sizes | Size Before ageing After ageingMedium 542% 503% |
| ASTM D5151-19 (Freedom from holes) | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06 (Residual Powder) | To determine the residual powder in the gloves | ≤ 2 mg/glove | Medium: 0.3516 mg/glove |
| ASTM D6978-05 (Chemotherapy Drugs Permeation) | To determine the breakthrough detection time of chemotherapy drugs | For listed drugs (e.g., Bleomycin Sulfate, Busulfan, Carboplatin, Cisplatin, Cyclophosphamide, Cytarabine, Dacarbazine, Daunorubicin HCl, Docetaxel, Doxorubicin HCl, Epirubicin HCl, Etoposide, Fludarabine, Fluorouracil, Gemcitabine, Idarubicin HCl, Ifosfamide, Irinotecan, Mechlorethamine HCl, Melphalan, Methotrexate, Mitomycin C, Mitoxantrone HCl, Paclitaxel, Rituximab, Trisenox, Vincristine Sulfate): >240 Minutes. Carmustine (3.3 mg/ml): Not specified as a pass/fail criterion, but a low permeation time is noted. Thiotepa (10.0 mg/ml): Not specified as a pass/fail criterion, but a low permeation time is noted. | For all 28 listed chemotherapy drugs, the breakthrough detection time was >240 Minutes. Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes |
| ISO 10993-23 (Primary Skin Irritation) | To evaluate the local dermal irritation in rabbits | Under the condition of study not an irritant | Under the conditions of the study, the test article met the requirements of the test. |
| ISO 10993-10 (Dermal Sensitization) | To evaluate the skin sensitization in Guinea pigs | Under the conditions of the study, not a sensitizer | Under the conditions of the study, the test article was not considered a sensitizer. |
| ISO 10993-5 (In Vitro Cytotoxicity) | To determine the potential to cause cytotoxicity | Under the conditions of the study, non-cytotoxic | The undiluted test article extract and 50% test article extract dilution did not meet the requirements of the test and the 25%, 12.5%, 6.25%, and 3.13% test article extract dilutions met the requirements of the test. The cytotoxic concern was addressed via acute systemic toxicity testing. (This result indicates some cytotoxicity at higher concentrations but was mitigated by systemic toxicity testing). |
| ISO 10993-11 (Acute Systemic Toxicity) | To evaluate the acute systemic toxicity in mice | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study, there was no mortality or evidence of systemic toxicity. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each test in the level of detail (e.g., number of gloves tested for each specific property or chemotherapy drug). It only refers to compliance with the standards (e.g., AQL 2.5 for freedom from holes).
The data provenance (country of origin, retrospective/prospective) is not mentioned. These are bench tests, not human trials or medical imaging data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable. The document describes bench testing of physical and chemical properties of gloves, not expert interpretation of medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The tests are laboratory-based and follow standardized testing protocols, which do not typically involve adjudication methods like those used for expert review of clinical cases.
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 information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not AI systems or medical imaging devices. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests is defined by the technical specifications and performance requirements outlined in the referenced ASTM and ISO standards. For example:
- Physical properties (length, width, thickness, tensile strength, elongation) are measured objectively against defined numerical limits.
- Freedom from holes is assessed against an Acceptable Quality Limit (AQL), a statistical measure.
- Resistance to chemotherapy drugs is measured by detecting breakthrough time using specific analytical methods defined in ASTM D6978.
- Biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity) are assessed by observing biological responses in animal models or in vitro systems against established criteria for non-irritancy, non-sensitization, and non-toxicity according to ISO standards.
Essentially, the "ground truth" reflects compliance with regulatory and industry standards for glove performance and safety.
8. The sample size for the training set
This information is not applicable, as this is not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable, as this is not a machine learning model.
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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.
February 9, 2023
Nephron Pharmaceuticals Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K223559
Trade/Device Name: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: February 1, 2023 Received: February 1, 2023
Dear Prithul Bom:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Allan Gu
For Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223559
Device Name
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
Indications for Use (Describe)
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
| Bleomycin Sulfate (15.0 mg/ml) | Doxorubicin HCl (2.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) |
|---|---|---|
| Busulfan (6.0 mg/ml) | Epirubicin HCl (2.0 mg/ml) | Melphalan (5.0 mg/ml) |
| Carboplatin (10.0 mg/ml) | Etoposide (20.0 mg/ml) | Methotrexate (25.0 mg/ml) |
| Cisplatin (1.0 mg/ml) | Fludarabine (25.0 mg/ml) | Mitomycin C (0.5 mg/ml) |
| Cyclophosphamide (20.0 mg/ml) | Fluorouracil (50.0 mg/ml) | Mitoxantrone HCl (2.0 mg/ml) |
| Cytarabine (100.0 mg/ml) | Gemcitabine (38.0 mg/ml) | Paclitaxel (6.0 mg/ml) |
| Dacarbazine (10.0 mg/ml) | Idarubicin HCl (1.0 mg/ml) | Rituximab (10.0 mg/ml) |
| Daunorubicin HCl (5.0 mg/ml) | Ifosfamide (50.0 mg/ml) | Trisenox (1.0 mg/ml) |
| Docetaxel (10.0 mg/ml) | Irinotecan (20.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) |
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes
Warning: Not for Use with: Carmustine, Thiotepa
| 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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510(K) SUMMARY K223559 AS REQUIRED BY: 21CFR§807.92
A. APPLICANT INFORMATION
| 510(K) Owner's Name | Nephron Pharmaceuticals Corporation |
|---|---|
| Address | 4500 12th Street Extension, West Columbia, SC29172. |
| Phone | 1-803-569-3110 |
| Fax | 1-803-926-9853 |
| lkennedy@nephronpharm.com | |
| Contact Person | Lou Kennedy |
| Designation | Chief Executive Officer |
| Contact Number | 1-803-569-3110 |
| Contact Email | lkennedy@nephronpharm.com |
| Date Submitted | 21 October 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | Nephron Nitrile Powder-Free Nitrile ExaminationGloves (Tested For Use With ChemotherapyDrugs) |
|---|---|
| Product proprietary or trade name | Nephron Nitrile |
| Common or usual name | Nitrile Examination Gloves (Tested for use withChemotherapy drugs) |
| Classification name | Non-Powdered Patient Examination Glove Specialty |
| Device Classification | Class-1, Reserved |
| Product Code | LZA, LZC, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital and Personal Use Devices |
C. PREDICATE DEVICE
| Predicate Device | Powder Free Nitrile Examination Gloves (Blue,Purple-Blue), Tested for Use with ChemotherapyDrugs |
|---|---|
| 510(k) Number | K213440 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC |
| Reference Device | SHOWA® Blue Nitrile Powder Free MedicalExamination Glove |
|---|---|
| 510(k) Number | K211003 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC |
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D. DESCRIPTION OF THE DEVICE:
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) with sizes Medium, Large, X-Large and XX-Large are included in the submission.
E. INDICATION FOR USE OF THE DEVICE:
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| The following chemotherapy drugs and concentration had NO breakthrough detected up to | ||
|---|---|---|
| 240 minutes: | ||
| Bleomycin Sulfate (15.0 mg/ml) | Doxorubicin HCl (2.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) |
| Busulfan (6.0 mg/ml) | Epirubicin HCl (2.0 mg/ml) | Melphalan (5.0 mg/ml) |
| Carboplatin (10.0 mg/ml) | Etoposide (20.0 mg/ml) | Methotrexate (25.0 mg/ml) |
| Cisplatin (1.0 mg/ml) | Fludarabine (25.0 mg/ml) | Mitomycin C (0.5 mg/ml) |
| Cyclophosphamide (20.0 mg/ml) | Fluorouracil (50.0 mg/ml) | Mitoxantrone HCl (2.0 mg/ml) |
| Cytarabine (100.0 mg/ml) | Gemcitabine (38.0 mg/ml) | Paclitaxel (6.0 mg/ml) |
| Dacarbazine (10.0 mg/ml) | Idarubicin HCl (1.0 mg/ml) | Rituximab (10.0 mg/ml) |
| Daunorubicin HCl (5.0 mg/ml) | Ifosfamide (50.0 mg/ml) | Trisenox (1.0 mg/ml) |
| Docetaxel (10.0 mg/ml) | Irinotecan (20.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) |
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes
Warning: Not for Use with: Carmustine, Thiotepa
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(K) Number | --- | K213440 | K211003 | K223559 | |
| Name of device | --- | Powder FreeNitrileExaminationGloves (Blue,Purple-Blue),Tested for Use withChemotherapyDrugs | SHOWA® BlueNitrile Powder FreeMedical ExaminationGlove | Nephron NitrilePowder-Free NitrileExamination Gloves(Tested For Use WithChemotherapy Drugs) | Similartopredicatedevice |
| Product Code | --- | LZA, LZC | LZA, LZC | LZA, LZC, OPJ | Similar |
| Indication for use | --- | Powder FreeNitrileExaminationGloves (Blue,Purple-Blue),Tested for Use withChemotherapyDrugs is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand topreventcontaminationbetween patientand examiner. | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hands orfingers to preventcontaminationbetween patient andexaminer.These gloves weretested for use withchemotherapy drugs inaccordance withASTM D6978-05Standard Practice forAssessment ofMedical Glove toPermeation bychemotherapy drugs. | Nephron NitrilePowder-Free NitrileExamination Gloves(Tested For Use WithChemotherapy Drugs)is a disposable deviceintended for medicalpurpose that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer. In addition,these gloves weretested for use withchemotherapy drugsin accordance withASTM D6978-05(2019) StandardPractice forAssessment ofResistance of MedicalGloves to Permeationby ChemotherapyDrugs. | Similar |
| Regulation Number | --- | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | --- | Nitrile | Nitrile | Nitrile | Same |
| Color | --- | Blue, Purple-Blue | Blue | Blue | Same |
| Size | --- | XS, S, M, L, XL | XS, S, M, L, XL | M, L, XL, XXL | Similar |
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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | ||||||||||||||||||
| 510(K) Number | --- | K213440 | K211003 | K223559 | ||||||||||||||||
| Single Use | --- | Single-use | Single-use | Single-use | Same | |||||||||||||||
| Sterile/non sterile | --- | Non Sterile | Non Sterile | Non Sterile | Same | |||||||||||||||
| Rx Only or OTC | --- | OTC | OTC | OTC | Same | |||||||||||||||
| Dimensions - Length | ASTM D6319-19 | Minimum 230mm | Overall Length (mm) = 220 mm (sizes XS – S) and 230 mm (sizes M – XL) | Minimum 230 mm | Similar | |||||||||||||||
| Size Average value M 235 L 237 XL 250 XXL 238 | ||||||||||||||||||||
| Dimensions - Width | ASTM D6319-19 | XS: 70±10S: 80±10M: 95±10L: 110±10XL: 120±10XXL: 130±10 | Width (± 10 mm)Size XS = 70 mmSize S = 80 mmSize M = 95 mmSize L = 110 mmSize XL = 120 mm | M: 95±10 mmL: 110±10 mmXL: 120±10 mmXXL: 130±10 mm | Same | |||||||||||||||
| Size Average value M 95 L 113 XL 121 XXL 129 | ||||||||||||||||||||
| Physical Properties- Tensile Strength | ASTM D6319-2019 | Before aging 14MPa, min | Before aging (MPa) = 14 min | Before aging 14MPa, minAverage value = 34.0 MPa (Medium) | Same | |||||||||||||||
| After aging 14MPa, min | After aging (MPa) = 14 min | After aging 14MPa, minAverage value = 37.3 MPa (Medium) | Same | |||||||||||||||||
| Physical Properties- Ultimate Elongation | ASTM D6319-2019 | Before aging 500%, min | Before aging (%) = 500 min | Before aging 500%, minAverage value = 542% (Medium) | Same | |||||||||||||||
| After aging 400%, min | After aging (%) = 400 min | After aging 400%, minAverage value = 503% (Medium) | Same | |||||||||||||||||
| Thickness | ASTM D6319-19 | Palm: Minimum 0.05 mmFinger: Minimum 0.05 mm | Palm (mm) = 0.05 minFinger Tip (mm) = 0.05 min | Palm: Minimum 0.05 mmFinger: Minimum 0.05 mm | Same | |||||||||||||||
| Size Palm (Avg value) Finger (Avg value) M 0.077 0.111 L 0.106 0.109 XL 0.089 0.115 XXL 0.113 0.107 |
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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||
|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | ||||
| 510(K) Number | K213440 | K211003 | ||||
| Powder Free Residue | ASTMD6319-19 | ≤ 2 mg per glove | ≤ 2.0 mg/pc | ≤2 mg per gloveAverage value = 0.3516mg/glove (Medium) | Same | |
| Freedom from holes | ASTM D5151-2019 | In accordance withASTM D 5151-19,following ASTMD6319-19,G-I, AQL 2.5 | AQL 2.5Inspection LevelG-1 | In accordance withASTM D 5151-19,following ASTMD6319-19,G-I, AQL 2.5 | Same | |
| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time | ASTM D6978-05 (2019) | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 Minutes | Blenoxane(15.0 mg/ml)>240 Minutes | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 Minutes | Same | |
| Busulfan6 mg/ml (6,000 ppm)>240 Minutes | Busulfan(6.0 mg/ml)>240 Minutes | Busulfan6 mg/ml (6,000 ppm)>240 Minutes | Same | |||
| Carboplatin10 mg/ml (10,000 ppm)>240 Minutes | Carboplatin(10.0 mg/ml)>240 Minutes | Carboplatin10 mg/ml (10,000 ppm)>240 Minutes | Same | |||
| Carmustine3.3 mg/ml (3,300 ppm)25.5 Minutes | Carmustine(3.3 mg/ml)73.7 Minutes | Carmustine3.3 mg/ml (3,300 ppm)33.8 Minutes | Similar | |||
| Chloroquine50mg/ml (50,000ppm)>240 Minutes | --- | Not tested | Optional* | |||
| Cisplatin1 mg/ml (1,000 ppm)>240 Minutes | Cisplatin(1.0 mg/ml)>240 Minutes | Cisplatin1 mg/ml (1,000 ppm)>240 Minutes | Same | |||
| Cyclophosphamide20 mg/ml (20,000 ppm)>240 Minutes | Cyclophosphamide(20.0 mg/ml)>240 Minutes | Cyclophosphamide20 mg/ml (20,000 ppm)>240 Minutes | Same | |||
| Cyclosporin100 mg/ml (100,000 ppm)>240 Minutes | --- | Not tested | Optional* | |||
| Cytarabine HCL100 mg/ml (100,000 ppm)>240 Minutes | --- | Not tested | Optional* | |||
| Cytarabine(100.0 mg/ml)>240 Minutes | Cytarabine100 mg/ml (100,000 ppm)>240 Minutes | Same asreferencedevice | ||||
| Dacarbazine10 mg/ml (10,000 ppm)>240 Minutes | Dacarbazine(10.0 mg/ml)>240 Minutes | Dacarbazine10 mg/ml (10,000 ppm)>240 Minutes | Same | |||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||
| 510(K) Number | PREDICATE | REFERENCE | SUBJECT | |||
| Chemotherapy DrugsTested with MinimumBreakthrough DetectionTime | ASTMD6978-05(2019) | Daunorubicin HCL5 mg/ml (5,000 ppm)>240 Minutes | Daunorubicin HCl(5.0 mg/ml)>240 Minutes | Daunorubicin HCl5 mg/ml (5,000 ppm)>240 Minutes | Same | |
| Docetaxel HCL10 mg/ml (10,000 ppm)>240 Minutes | --- | Not tested | Optional* | |||
| Docetaxel(10.0 mg/ml)>240 Minutes | Docetaxel10 mg/ml (10,000 ppm)>240 Minutes | Same asreferencedevice | ||||
| Doxorubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Doxorubicin HCl(2.0 mg/ml)>240 Minutes | Doxorubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Same | |||
| Epirubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Epirubicin HCl (2.0mg/ml)>240 Minutes | Epirubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Same | |||
| Etoposide20 mg/ml (20,000 ppm)>240 Minutes | Etoposide(20.0 mg/ml)>240 Minutes | Etoposide20 mg/ml (20,000 ppm)>240 Minutes | Same | |||
| Fludarabine25 mg/ml (25,000 ppm)>240 Minutes | Fludarabine(25.0 mg/ml)>240 Minutes | Fludarabine25 mg/ml (25,000 ppm)>240 Minutes | Same | |||
| Fluorouracil50 mg/ml (50,000 ppm)>240 Minutes | Fluorouracil(50.0 mg/ml)>240 Minutes | Fluorouracil50 mg/ml (50,000 ppm)>240 Minutes | Same | |||
| Gemcitabine38 mg/ml (38,000 ppm)>240 Minutes | Gemcitabine(38.0 mg/ml)>240 Minutes | Gemcitabine38 mg/ml (38,000 ppm)>240 Minutes | Same | |||
| Idarubicin HCl1 mg/ml (1,000 ppm)>240 Minutes | Idarubicin HCl (1.0mg/ml)>240 Minutes | Idarubicin HCl1 mg/ml (1,000 ppm)>240 Minutes | Same | |||
| Ifosfamide50 mg/ml (50,000 ppm)>240 Minutes | Ifosfamide(50.0 mg/ml)>240 Minutes | Ifosfamide50 mg/ml (50,000 ppm)>240 Minutes | Same | |||
| Irinotecan20 mg/ml (20,000 ppm)>240 Minutes | Irinotecan(20.0 mg/ml)>240 Minutes | Irinotecan20 mg/ml (20,000 ppm)>240 Minutes | Same | |||
| Mechlorethamine HCl1 mg/ml (1,000 ppm)>240 Minutes | MechlorethamineHCl (1.0 mg/ml)>240 Minutes | Mechlorethamine HCl1 mg/ml (1,000 ppm)>240 Minutes | Same | |||
| Melphalan5 mg/ml (5,000 ppm)>240 Minutes | Melphalan(5.0 mg/ml)>240 Minutes | Melphalan5 mg/ml (5,000 ppm)>240 Minutes | Same | |||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||
| PREDICATE | REFERENCE | SUBJECT | ||||
| 510(K) Number | K213440 | K211003 | ||||
| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time | ASTMD6978-05(2019) | Methotrexate25 mg/ml (25,000 ppm)>240 Minutes | Methotrexate(25.0 mg/ml)>240 Minutes | Methotrexate25 mg/ml (25,000 ppm)>240 Minutes | Same | |
| Mitomycin0.5 mg/ml (500 ppm)>240 Minutes | Mitomycin C(0.5 mg/ml)>240 Minutes | Mitomycin C0.5 mg/ml (500 ppm)>240 Minutes | Same | |||
| Mitoxantrone HCL2 mg/ml (2,000 ppm)>240 Minutes | Mitoxantrone HCl2 mg/ml (2,000 ppm)>240 Minutes | Same aspredicatedevice | ||||
| Mitoxantrone(2.0 mg/ml)>240 Minutes | Not tested | Optional* | ||||
| Oxaliplatin5mg/ml (5,000ppm)>240 Minutes | Not tested | Optional* | ||||
| Paclitaxel6 mg/ml (6,000 ppm)>240 Minutes | Paclitaxel(6.0 mg/ml)>240 Minutes | Paclitaxel6 mg/ml (6,000 ppm)>240 Minutes | Same | |||
| Paraplatin/Carboplatin,10mg/ml (10,000ppm)>240 Minutes | Not tested | Optional* | ||||
| Retrovir10mg/ml (10,000ppm)>240 Minutes | Not tested | Optional* | ||||
| Rituximab10mg/ml (10,000 ppm)>240 Minutes | Rituximab(10.0 mg/ml)>240 Minutes | Rituximab10 mg/ml (10,000 ppm)>240 Minutes | Same | |||
| Thiotepa10mg/ml (10,000 ppm)66.8 Minutes | ThioTepa(10.0 mg/ml)25.4 Minutes | Thiotepa10 mg/ml (10,000 ppm)128.1 Minutes | Similar | |||
| Topotecan1mg/ml (1,000ppm)>240 Minutes | Not tested | Optional* | ||||
| Trisenox1 mg/ml (1,000 ppm)>240 Minutes | Trisenox(1.0 mg/ml)>240 Minutes | Trisenox1 mg/ml (1,000 ppm)>240 Minutes | Same | |||
| Velcade (Bortezomib)1mg/ml (1,000ppm)>240 Minutes | Not tested | Optional* | ||||
| Vincristine Sulfate1 mg/ml (1,000 ppm)>240 Minutes | Vincristine Sulfate(1.0 mg/ml)>240 Minutes | Vincristine Sulfate1 mg/ml (1,000 ppm)>240 Minutes | Same | |||
| CHARACTERISTICS STANDARDS | DEVICE PERFORMANCE | Comparison | ||||
| PREDICATE | REFERENCE | SUBJECT | ||||
| 510(K) Number | --- | K213440 | K211003 | K223559 | ||
| Biocompatibility | Primary SkinIrritation- ISO10993-23: FirstEdition 2021-01 | Under the conditions ofthe study, not an irritant | Under theconditions of thestudy, not aprimary skinirritant. | Under the conditions ofthe study, the test articlemet the requirements ofthe test | Same | |
| DermalSensitization-ISO 10993-10:Fourth Edition2021-11 | Under the conditions ofthe study, not a sensitizer | Under conditionsof the study, not acontact sensitizer | Under the conditions ofthe study, the test articlewas not considered asensitizer | Same | ||
| In vitrocytotoxicity-ISO 10993-5:Third Edition2009-06-01 | Under the conditions ofthis study, the test articleextract showed potentialtoxicity | --- | Under the conditions ofthe study, the undilutedtest article extract and50% test article extractdilution did not meet therequirements of the testand the 25%, 12.5%,6.25%, and 3.13% testarticle extract dilutionsmet the requirements ofthe test | Similar topredicatedevice | ||
| AcuteSystemicToxicity- ISO10993-11:Third Edition2017-09 | Under the conditions ofthis study, there was noevidence of systemictoxicity. | Under conditionsof the ISO AcuteSystemic Injectiontest, not toxic | Under the conditions ofthe study, there was nomortality or evidence ofsystemic toxicity | Same |
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- Predicate device / reference device perform additional Chemotherapy drug test.
Reference device has been included in the 510k to prove the safety of subject device with respect to the use of chemotherapy drug Cytarabine and Docetaxel which was not tested in case of predicate device.
There are no significant differences between the products and are identical in terms of intended use, materials, design and manufacturing methods. The devices meet the ASTM standard D6319-19 and D6978-05 (2019).
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G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA
BENCH TEST DATA
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thelength of the gloves | Medium : 230 mm minLarge : 230 mm minX-Large : 230 mm minXX-Large : 230 mm min | Medium : 235 mmLarge : 237 mmX-Large : 250 mmXX-Large : 238 mm | |||||||||||||||
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thewidth of the gloves | Medium : 95+/-10 mmLarge : 110+/-10 mmX-Large : 120+/-10 mmX-Large : 130+/-10 mm | Medium : 95 mmLarge : 113 mmX-Large : 121 mmXX-Large : 129 mm | |||||||||||||||
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thethickness of thegloves | Palm: 0.05 mm minfor all sizesFinger: 0.05 mm minfor all sizes | Size Palm Finger Medium 0.077 mm 0.111 mm Large 0.106 mm 0.109 mm X-Large 0.089 mm 0.115 mm XX-Large 0.113 mm 0.107 mm | |||||||||||||||
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14MPa min for all sizesAfter AgeingTensile Strength14MPa min for all sizes | Size Beforeageing Afterageing Medium 34.0 MPa 37.3 MPa | |||||||||||||||
| To determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% min for all sizesAfter AgeingUltimate Elongation400% min for all sizes | Size Beforeageing Afterageing Medium 542% 503% | ||||||||||||||||
| ASTM D5151-19 StandardTest Method for Detectionof Holes in Medical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 | |||||||||||||||
| ASTM D6124-06(Reapproved 2017) StandardTest Method for ResidualPowder on Medical Gloves | To determine theresidual powder in thegloves | ≤ 2 mg/glove | Medium: 0.3516 mg/glove |
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| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs. | To determine thebreakthroughdetection time ofchemotherapydrugs | Bleomycin Sulfate 15 mg/ml(15,000 ppm) >240 Minutes | Bleomycin Sulfate 15 mg/ml(15,000 ppm) >240 Minutes |
| Busulfan 6 mg/ml(6,000 ppm) >240 Minutes | Busulfan 6 mg/ml(6,000 ppm) >240 Minutes | ||
| Carboplatin 10 mg/ml(10,000 ppm) >240 Minutes | Carboplatin 10 mg/ml(10,000 ppm) >240 Minutes | ||
| Cisplatin 1 mg/ml(1,000 ppm) >240 Minutes | Cisplatin 1 mg/ml(1,000 ppm) >240 Minutes | ||
| Cyclophosphamide 20 mg/ml(20,000 ppm) >240 Minutes | Cyclophosphamide 20 mg/ml(20,000 ppm) >240 Minutes | ||
| Cytarabine 100 mg/ml(100,000 ppm) >240 Minutes | Cytarabine 100 mg/ml(100,000 ppm) >240 Minutes | ||
| Dacarbazine 10 mg/ml(10,000 ppm) >240 Minutes | Dacarbazine 10 mg/ml(10,000 ppm) >240 Minutes | ||
| Daunorubicin HCl 5 mg/ml(5,000 ppm) >240 Minutes | Daunorubicin HCl 5 mg/ml(5,000 ppm) >240 Minutes | ||
| Docetaxel 10 mg/ml(10,000 ppm) >240 Minutes | Docetaxel 10 mg/ml(10,000 ppm) >240 Minutes | ||
| Doxorubicin HCl 2 mg/ml(2,000 ppm) >240 Minutes | Doxorubicin HCl 2 mg/ml(2,000 ppm) >240 Minutes | ||
| Epirubicin HCl 2 mg/ml(2,000 ppm) >240 Minutes | Epirubicin HCl 2 mg/ml(2,000 ppm) >240 Minutes | ||
| Etoposide 20 mg/ml(20,000 ppm) >240 Minutes | Etoposide 20 mg/ml(20,000 ppm) >240 Minutes | ||
| Fludarabine 25 mg/ml(25,000 ppm) >240 Minutes | Fludarabine 25 mg/ml(25,000 ppm) >240 Minutes | ||
| Fluorouracil 50 mg/ml(50,000 ppm) >240 Minutes | Fluorouracil 50 mg/ml(50,000 ppm) >240 Minutes | ||
| Gemcitabine 38 mg/ml(38,000 ppm) >240 Minutes | Gemcitabine 38 mg/ml(38,000 ppm) >240 Minutes | ||
| Idarubicin HCl 1 mg/ml(1,000 ppm) >240 Minutes | Idarubicin HCl 1 mg/ml(1,000 ppm) >240 Minutes | ||
| Ifosfamide 50 mg/ml(50,000 ppm) >240 Minutes | Ifosfamide 50 mg/ml(50,000 ppm) >240 Minutes | ||
| Irinotecan 20 mg/ml(20,000 ppm) >240 Minutes | Irinotecan 20 mg/ml(20,000 ppm) >240 Minutes | ||
| Mechlorethamine HCl 1 mg/ml(1,000 ppm) >240 Minutes | Mechlorethamine HCl 1 mg/ml(1,000 ppm) >240 Minutes | ||
| Melphalan 5 mg/ml(5,000 ppm) >240 Minutes | Melphalan 5 mg/ml(5,000 ppm) >240 Minutes | ||
| Methotrexate 25 mg/ml(25,000 ppm) >240 Minutes | Methotrexate 25 mg/ml(25,000 ppm) >240 Minutes | ||
| Mitomycin C 0.5 mg/ml(500 ppm) >240 Minutes | Mitomycin C 0.5 mg/ml(500 ppm) >240 Minutes | ||
| Mitoxantrone HCl 2 mg/ml(2,000 ppm) >240 Minutes | Mitoxantrone HCl 2 mg/ml(2,000 ppm) >240 Minutes | ||
| Paclitaxel 6 mg/ml(6,000 ppm) >240 Minutes | Paclitaxel 6 mg/ml(6,000 ppm) >240 Minutes | ||
| Rituximab 10 mg/ml(10,000 ppm) >240 Minutes | Rituximab 10 mg/ml(10,000 ppm) >240 Minutes | ||
| Trisenox 1 mg/ml(1,000 ppm) >240 Minutes | Trisenox 1 mg/ml(1,000 ppm) >240 Minutes | ||
| Vincristine Sulfate 1 mg/ml(1,000 ppm) >240 Minutes | Vincristine Sulfate 1 mg/ml(1,000 ppm) >240 Minutes |
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BIOCOMPATIBILITY DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ISO 10993-23 First edition2021-01 BiologicalEvaluation of MedicalDevices - Part 23, Tests forIrritation. | To evaluate the localdermal irritation of a testarticle extract followingintracutaneous injection inrabbits. | Under the condition ofstudy not an irritant | Under the conditions of thestudy, the test article met therequirements of the test |
| 10993-10 Fourth edition2021-11 BiologicalEvaluation of MedicalDevices - Part 10, Tests forSkin Sensitization. | To evaluate the test item,for the skin sensitizationin Guinea pigs bymaximization test. | Under the conditions ofthe study, not asensitizer | Under the conditions of thestudy, the test article was notconsidered a sensitizer |
| ISO 10993-5 Third edition2009-06-01 BiologicalEvaluation of MedicalDevices - Part 5, Tests forIn Vitro Cytotoxicity. | To determine the potentialof a test article to causecytotoxicity | Under the conditions ofthe study, non-cytotoxic | The undiluted test articleextract and 50% test articleextract dilution did not meetthe requirements of the testand the 25%, 12.5%, 6.25%,and 3.13% test article extractdilutions met therequirements of the test. Thecytotoxic concern wasaddressed via acute systemictoxicity testing |
| ISO 10993-11 Third edition2017-09 BiologicalEvaluation of MedicalDevices - Part 11, Tests forSystemic Toxicity | To evaluate the acutesystemic toxicity of a testarticle extract followinginjection in mice. | Under the conditions ofstudy, the deviceextracts do not pose asystemic toxicityconcern | Under the conditions ofstudy, there was no mortalityor evidence of systemictoxicity |
The performance test data of the non-clinical tests that support a determination of safety and equivalence is the same as mentioned above (ASTM Requirements).
The performance test data of the non-clinical tests meet following standards:
ASTM D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application.
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves.
ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
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ISO 10993-23 First Edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation.
ISO 10993-10 Fourth Edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization.
ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity.
ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.
H. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves.
I. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) submission, Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K213440.
§ 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.