(110 days)
Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
Busulfan, 6 mg/ml (6,000 ppm)
Carboplatin /Paraplatin, 10 mg/ml (10,000 ppm)
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm)
Cytarabine HCI, 100 mg/ml (100,000 ppm)
Dacarbazine, 10.0 mg/ml (10,000 ppm)
Docetaxel, 10 mg/ml (10,000 ppm)
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm)
Etoposide, 20.0 mg/ml (20,000 ppm)
Fluorouracil, 50.0 mg/ml (50,000 ppm)
Ifosfamide, 50 mg/ml (50,000 ppm)
Mechlorethamine HCI, 1 mg/ml (1,000 ppm)
Methotrexate, 25 mg/ml (25,000 ppm)
Mitomycin, 0.5 mg/ml (500 ppm)
Mitoxantrone, 2 mg/ml (2,000 ppm)
Paclitaxel, 6.0 mg/ml (6,000 ppm)
Vincristine Sulfate, 1 mg/ml (1,000 ppm)
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes
WARNING: Do not use Carmustine and Thiotepa
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
This document describes the acceptance criteria and performance of "Disposable Medical Nitrile Examination Gloves (Non sterile)" (K212639).
This medical device is a Class I device and does not involve AI or human interpretation of medical images. Therefore, many of the requested categories in the prompt are not applicable. The information provided is based on the provided FDA 510(k) summary, which focuses on physical, chemical, and biological testing as per relevant ASTM and ISO standards for examination gloves.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | ||
| Size Small | Width: 80 mm ± 10mm Length: 220 mm (Minimum) Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05 mm (Minimum) | Width: 82mm-89mm Length: 230mm (Minimum) Thickness: Finger 0.12mm (Minimum), Palm 0.08mm (Minimum) Passed | |
| Size Medium | Width: 95 mm ± 10mm Length: 230 mm (Minimum) Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05 mm (Minimum) | Width: 91mm-96mm Length: 240mm (Minimum) Thickness: Finger 0.13mm (Minimum), Palm 0.08mm (Minimum) Passed | |
| Size Large | Width: 110 mm ± 10mm Length: 230 mm (Minimum) Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05 mm (Minimum) | Width: 111mm-113mm Length: 240mm (Minimum) Thickness: Finger 0.13mm (Minimum), Palm 0.09mm (Minimum) Passed | |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Acceleration Aging: Tensile Strength (MPa): 14 (Minimum), Ultimate Elongation (%): 500 (Minimum) After Acceleration Aging: Tensile Strength (MPa): 14 (Minimum), Ultimate Elongation (%): 400 (Minimum) | Before Acceleration Aging: Tensile Strength (MPa): 29 (Minimum), Ultimate Elongation (%): 515 (Minimum) After Acceleration Aging: Tensile Strength (MPa): 26 (Minimum), Ultimate Elongation (%): 511 (Minimum) Passed |
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | (Mean) AQL 2.5 | Passed |
| ASTM D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | ≤ 2.0 mg/glove | 0.2 mg/glove, Passed |
| ASTM D6978-05 Testing with Chemotherapy Drugs | To assess resistance to permeation by chemotherapy drugs | No breakthrough detected up to 240 minutes for specified drugs; permeation times for Carmustine and Thiotepa noted as less than 60 minutes. | No breakthrough detected up to 240 minutes for: Busulfan, Carboplatin /Paraplatin, Cisplatin, Cyclophosphamide (Cytoxan), Cytarabine HCI, Dacarbazine, Docetaxel, Doxorubicin HCI, Etoposide, Fluorouracil, Ifosfamide, Mechlorethamine HCI, Methotrexate, Mitomycin, Mitoxantrone, Paclitaxel, Vincristine Sulfate. Low permeation times of less than 60 minutes for: Carmustine (BCNU) (44.7 minutes), ThioTepa (35.7 minutes). |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the potential of the material to produce skin irritation in rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential in guinea pigs | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | To evaluate the in vitro cytotoxic potential of the test item | Under the conditions of study, no more than grade 2 cytotoxic reaction | Slight (Grade 1) cytotoxicity reaction observed. |
2. Sample sized 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 physical and chemical test (e.g., number of gloves tested for dimensions, holes, etc.). The testing was conducted according to established ASTM and ISO standards, which typically specify the required sample sizes for each test.
The data provenance is from Jiangsu Nanfang Medical Co., Ltd in China. The tests were non-clinical, laboratory-based performance tests, not involving human subjects or patient data, so the terms "retrospective" or "prospective" are not applicable in this context.
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 is not applicable. The "ground truth" for this device is based on objective, quantifiable physical, chemical, and biological measurements performed according to standardized testing protocols (e.g., ASTM, ISO). There is no "expert" interpretation or "ground truth" establishment in the sense of clinical image analysis or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the testing involves objective laboratory measurements, not subjective evaluations or interpretation requiring adjudication.
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. This device is a disposable medical glove and does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device is based on objective measurements obtained through standardized physical, chemical, and biological testing methods (ASTM and ISO standards). Examples include:
- Precise measurements of dimensions (width, length, thickness).
- Quantifiable tensile strength and elongation.
- Measured breakthrough times for chemotherapy drugs.
- Results from established biocompatibility tests (skin irritation, sensitization, cytotoxicity) with clear pass/fail criteria.
8. The sample size for the training set
This is not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 8, 2021
Jiangsu Nanfang Medical Co., Ltd Johnson Liu Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia
Re: K212639
Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Non sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZC, LZA Dated: November 8, 2021 Received: November 12, 2021
Dear Johnson Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray III, PhD 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212639
Device Name
Disposable Medical Nitrile Examination Gloves (Non Sterile)
Indications for Use (Describe)
Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
| Busulfan,6 mg/ml (6,000 ppm) | Fluorouracil,50.0 mg/ml (50,000 ppm) |
|---|---|
| Carboplatin /Paraplatin,10 mg/ml (10,000 ppm) | Ifosfamide,50 mg/ml (50,000 ppm) |
| Cisplatin,1.0 mg/ml (1,000 ppm) | Mechlorethamine HCI,1 mg/ml (1,000 ppm) |
| Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) | Methotrexate,25 mg/ml (25,000 ppm) |
| Cytarabine HCI,100 mg/ml (100,000 ppm) | Mitomycin,0.5 mg/ml (500 ppm) |
| Dacarbazine,10.0 mg/ml (10,000 ppm) | Mitoxantrone,2 mg/ml (2,000 ppm) |
| Docetaxel,10 mg/ml (10,000 ppm) | Paclitaxel,6.0 mg/ml (6,000 ppm) |
| Doxorubicin HCI,2.0 mg/ml (2,000 ppm) | Vincristine Sulfate,1 mg/ml (1,000 ppm) |
| Etoposide,20.0 mg/ml (20,000 ppm) |
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes
WARNING: Do not use Carmustine and 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a logo for Miao Shou. The logo is a green circle with a green flower inside. The flower has a hand in the center. The words "Miao Shou" are written in English and Chinese on either side of the flower.
510(K) Summary
Disposable Medical Nitrile Examination Gloves (Non sterile)
Preparation Date: November 8th, 2021
1. SUBMITTER
Company Name: Jiangsu Nanfang Medical Co.,Ltd Company Address: No.1 Guoxiang RD. Wujin Economic Development Zone, WUJIN CHANGZHOU Jiangsu, CN 213149
Contact Person: Johnson Liu Telephone Number: +614-0158-9995 Email: Johnson@cnmed.com.au
2. NAME OF THE DEVICE
Trade Name / Proprietary Name: Disposable Medical Nitrile Examination Gloves (Non sterile) Device Name: Disposable Medical Examination Nitrile Gloves Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZC LZA
3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
Predicate Device: K172525 Applicant: Central Medicare Sdn. Bhd Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZC LZA Review Panel: General Hospital
4. DEVICE DESCRIPTION
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image is a logo for a company called "Miao Shou". The logo is a green circle with a green flower in the center. The flower has a hand in the middle of it. The words "Miao Shou" are written in English and Chinese on either side of the flower. There is a registered trademark symbol in the upper right corner of the logo.
5. INDICATIONS for USE OF THE DEVICE
Disposable Medical Nitrile Examination Gloves (Non sterile) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
| Busulfan,6 mg/ml (6,000 ppm) | Fluorouracil,50.0 mg/ml (50,000 ppm) |
|---|---|
| Carboplatin /Paraplatin,10 mg/ml (10,000 ppm) | Ifosfamide,50 mg/ml (50,000 ppm) |
| Cisplatin,1.0 mg/ml (1,000 ppm) | Mechlorethamine HCI,1 mg/ml (1,000 ppm) |
| Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) | Methotrexate,25 mg/ml (25,000 ppm) |
| Cytarabine HCI,100 mg/ml (100,000 ppm) | Mitomycin,0.5 mg/ml (500 ppm) |
| Dacarbazine,10.0 mg/ml (10,000 ppm) | Mitoxantrone,2 mg/ml (2,000 ppm) |
| Docetaxel,10 mg/ml (10,000 ppm) | Paclitaxel,6.0 mg/ml (6,000 ppm) |
| Doxorubicin HCI,2.0 mg/ml (2,000 ppm) | Vincristine Sulfate,1 mg/ml (1,000 ppm) |
| Etoposide,20.0 mg/ml (20,000 ppm) |
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mg/ml (10,000 ppm),35.7 minutes
WARNING: Do not use Carmustine and Thiotepa
{5}------------------------------------------------
6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES
| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | SUBJECT | PREDICATE | REMARKS | |
| 510(k) Number | K212639 | K172525 | - | |
| Device Name | Disposable Medical NitrileExamination Gloves (Non sterile) | Blue Non Sterile Powder FreeNitrile Examination GlovesTested for Use withChemotherapy Drugs | - | |
| Product Code | LZC LZA | LZC LZA | Same | |
| Indications for Use | Disposable Medical NitrileExamination Gloves (Non sterile) area disposable device intended formedical purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer. | Blue Non Sterile Powder FreeNitrile Examination GlovesTested for Use withChemotherapy Drugs is adisposable device intended formedical purposes that is wornonthe examiner's hands toprevent contamination betweenpatient and examiner. | Same | |
| Chemotherapy Drugs PermeationClaim | Busulfan, Carboplatin /Paraplatin,Cisplatin, Cyclophosphamide(Cytoxan), Cytarabine HCI,Dacarbazine, Docetaxel, DoxorubicinHCI, Etoposide, Fluorouracil,Ifosfamide, Mechlorethamine HCI,Methotrexate, Mitomycin,Mitoxantrone, Paclitaxel, VincristineSulfate. | Fluorouracil, Etoposide(Toposar), Cyclophosphamid(Cytoxan), Carmustine(BCNU), Thiotepa, Paclitaxel(Taxol), DoxorubicinHydrochloride, Dacarbazine(DTIC), Cisplatin,Ifosfamide, Mitoxantrone,Vincristine Sulfate | Equivalent | |
| Materials of Use(ASTMD6910/D6910M-19) | Nitrile compound | Nitrile compound | Same | |
| Color | Blue | Blue | Same | |
| Texture | Finger Textured | Finger Textured | Same | |
| Size(ASTM D6319-19) | Small, Medium, Large, | Small, Medium, Large,Extra Large | Same | |
| Sterilization | Non-sterile | Non-sterile | Same | |
| Usage | Single usage | Single usage | Same | |
| Dimensions(ASTM D6319-19) | Length Min. 220 min Width Min80+/-10 mm (for small size)Length Min. 230 min Width Min95+/-10 mm (for medium size)Length Min. 230 min Width Min110+/-10 mm (for large size) | Length Min. 230 min Width Min80+/-10 mm (for small size)Length Min. 230 min Width Min95+/-10 mm (for medium size)Length Min. 230 min Width Min110+/-10 mm (for large size) | Equivalent | |
| Physical Properties(ASTM D6319-19) | Before AgingTensile StrengthMin 14 Mpa Ultimate ElongationMin 500%After AgingTensile StrengthMin 14 Mpa Ultimate ElongationMin 400% | Same | ||
| Thickness(ASTM D6319-19) | Palm min 0.05 mm | Palm min 0.08 mm | Equivalent | |
| Finger min 0.05 mm | Finger min 0.10 mm | |||
| Powder Free(ASTM D6319-19) | <2 mg/glove<0.52 mg/glove | Equivalent | ||
| Freedom from Holes(Water Tight -1000 ml) -ASTM D6319-19 (CrossReference D5151) | AQL 2.5 | AQL 2.5 | Same | |
| Passed | Passed | |||
| Biocompatibility -SKIN SENSITIZATION -ISO 10993-10: 2010 (E) | Under the conditions of study not asensitizer | Under the conditions of studynot a sensitizer | Same | |
| Biocompatibility -SKIN IRRITATION - ISO10993-10: 2010 (E) | Under the conditions ofthe study not an irritant | Under the conditions ofthe study not an irritant | Same | |
| Biocompatibility - INVITRO CYTOTOXICITY- ISO10993-5: 2009(E) | Under the conditions of thecytotoxicity study, mildSystemic cytotoxicity (Grade 2)observed. It complied with thecriteria in ISO 10993-5:2009. | No information provided | Equivalent | |
| Manufacturer(s) | Jiangsu Nanfang Medical Co.,Ltd | Central Medicare Sdn. Bhd | --- |
{6}------------------------------------------------
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19 and tested for the use with chemotherapy drugs.
{7}------------------------------------------------
7. NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalDimensions Test | To determine thewidth, length, andthickness of thegloves | Size Small | Width:82mm-89mm |
| Width:$80 mm \pm 10mm$ | Length230mm (Minimum) | ||
| Length:220 mm (Minimum) | ThicknessFinger0.12mm (Minimum) | ||
| Thickness:Finger -0.05 mm(Minimum)Palm -0.05 mm(Minimum) | Palm0.08mm (Minimum) | ||
| Passed | |||
| Size Medium | Width:91mm-96mm | ||
| Width:$95 mm \pm 10mm$ | Length240mm (Minimum) | ||
| Length:230 mm (Minimum) | ThicknessFinger0.13mm (Minimum) | ||
| Thickness:Finger -0.05 mm(Minimum)Palm -0.05 mm(Minimum) | Palm0.08mm (Minimum) | ||
| Passed | |||
| Size Large | Width:111mm-113mm | ||
| Width:$110 mm \pm 10mm$ | Length240mm (Minimum) | ||
| Length:230 mm (Minimum) | ThicknessFinger0.13mm (Minimum) | ||
| Thickness:Finger -0.05 mm(MinimumPalm -0.05 mm(Minimum) | Palm0.09mm (Minimum) | ||
| Passed | |||
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalRequirements Test | To determine thetensile strength andultimate elongationbefore and afteracceleration aging | Before Acceleration Aging:Tensile Strength (MPa):14 (Minimum)Ultimate Elongation (%):500 (Minimum)After Acceleration Aging:Tensile Strength (MPa):14 (Minimum)Ultimate Elongation (%):400 (Minimum) | Before Acceleration Aging:Tensile Strength (MPa):29 (Minimum)Ultimate Elongation (%):515 (Minimum)After Acceleration Aging:Tensile Strength (MPa):26 (Minimum)Ultimate Elongation (%):511 (Minimum) |
| ASTM D6319-19(ASTM D5151-11)Standard Test Methodfor Detection of Holes inMedical Gloves | To determine theholes in the gloves | (Mean)AQL 2.5 | Passed |
| ASMT D6319-19(ASTM D6124-11)Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | $≤$ 2.0 mg/glove | 0.2 mg/glove, Passed |
{8}------------------------------------------------
{9}------------------------------------------------
Testing with Chemotherapy Drugs as per ASTM D6978-05.
| Busulfan,6 mg/ml (6,000 ppm) | Fluorouracil,50.0 mg/ml (50,000 ppm) |
|---|---|
| Carboplatin /Paraplatin,10 mg/ml (10,000 ppm) | Ifosfamide,50 mg/ml (50,000 ppm) |
| Cisplatin,1.0 mg/ml (1,000 ppm) | Mechlorethamine HCI,1 mg/ml (1,000 ppm) |
| Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) | Methotrexate,25 mg/ml (25,000 ppm) |
| Cytarabine HCI,100 mg/ml (100,000 ppm) | Mitomycin,0.5 mg/ml (500 ppm) |
| Dacarbazine,10.0 mg/ml (10,000 ppm) | Mitoxantrone,2 mg/ml (2,000 ppm) |
| Docetaxel,10 mg/ml (10,000 ppm) | Paclitaxel,6.0 mg/ml (6,000 ppm) |
| Doxorubicin HCI,2.0 mg/ml (2,000 ppm) | Vincristine Sulfate,1 mg/ml (1,000 ppm) |
| Etoposide,20.0 mg/ml (20,000 ppm) |
The following drugs had NO breakthrough detected up to 240 minutes:
The drugs have low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mg/ml (10,000 ppm),35.7 minutes
BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the potential of the material under test to produce skin irritation in rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential of the material both in terms of induction and elicitation in guinea pigs. | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method | Under the conditions of study, no more than grade 2 cytotoxic reaction | Slight (Grade 1) cytotoxicity reaction observed. |
{10}------------------------------------------------
8. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Disposable Medical Nitrile Examination Gloves (Non Sterile) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K172525- Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.
§ 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.