(244 days)
Not Found
No
The document describes a physical medical device (examination glove) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is described as a glove intended to prevent contamination between a patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is described as a "powder-free patient examination glove" intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic.
No
The device description clearly indicates it is a physical glove made of polychloroprene, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical examinations.
- Device Description: The description details a physical glove made of polychloroprene.
- Performance Studies: The performance studies focus on physical characteristics (dimensions, strength, freedom from holes), biocompatibility (skin irritation, sensitization, toxicity), and resistance to chemotherapy drug permeation. These are all tests related to the physical properties and safety of a barrier device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, collect a sample for diagnostic testing, or perform any analysis on a biological sample.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have extremely low permeation times: Carmustine: 45.4 minutes and Thiotepa: 23.5 minutes. Warning: Do not use with Carmustine or Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Microflex 73-743 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs is a non-sterile, single use only, disposable, powder free examination gloves.
Characteristics:
- . Ambidextrous with beaded cuff and straight fingers
- Finger-textured .
- . Blue colored
- Five (5) sizes – extra-small, small, medium, large, and extra-large
- . Tested against chemotherapy drugs
High levels of ozone will degrade rubber material of the glove; therefore, the glove should be protected from ozone in particular.
The glove is designed to meet the specifications of ASTM D6977-19, Standard Specification for Polychloroprene Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed as summarized in the following table:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Physical Characteristics: Dimensions: Length | Standard Specification for Polychloroprene Examination Gloves for Medical Application | ASTM D6977-19 | Meets ASTM D6977-19 requirements for length, width and thickness |
| Length | Minimum 230mm | Minimum 240mm | |
| Palm width (mm) | |||
| Size — XS | 70 ± 10 | 75 ± 5 | |
| Size — S | 80 ± 10 | 85 ± 5 | |
| Size - M | 95 ± 10 | 95 ± 5 | |
| Size - L | 110 ± 10 | 105 ± 5 | |
| Size - XL | 120 ± 10 | 115 ± 5 | |
| Thickness (mm) - single-wall Finger | minimum 0.05 | Finger - min 0.09 | |
| Palm | minimum 0.05 | Palm - min 0.06 | |
| Cuff | - | Cuff - min 0.05 | |
| Physical Properties: Tensile Strength Before Aging | Standard Specification for Polychloroprene Examination Gloves for Medical Application | Meets ASTM D6977-19 requirements for tensile strength and ultimate elongation before and after accelerated aging: minimum 14 MPa | minimum 16 MPa |
| After Aging | minimum 14 MPa | minimum 14 MPa | |
| Ultimate Elongation Before Aging | minimum 500% | minimum 500% | |
| After Aging | minimum 400% | minimum 400% | |
| Freedom from holes | Standard Test Method for Detection of Holes in Medical Gloves | ASTM D6977-19 ASTM D5151-06 | Meets or exceeds ASTM D6977-19 and ASTM D5151-06 requirements of AQL 2.5 |
| Powder Residual | Standard Test Method for Residual Powder on Medical Gloves | ASTM D6977-19 ASTM D6124-06 | Meets applicable requirement for powder free; ≤ 2 mg per glove |
| Biocompatibility: ISO Skin Irritation Study | Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization | ISO10993-10:2010 | Under the conditions of the study, not an irritant |
| ISO Maximization Sensitization Study | Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization | ISO 10993-10:2010 | Under the conditions of the study, not a sensitizer |
| ISO Acute Systemic Toxicity | Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity | ISO 10993-11: 2006 | Under the conditions of the study, no evidence of systemic toxicity |
| ISO In Vitro Cytotoxicity | Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study undiluted, 1:2, and 1:4 dilutions were cytotoxic (grade 4). Dilutions of 1:8 (grade 2), 1:16 (grade 1), 1:32 and 1:64 (grade 0) were non-cytotoxic |
A clinical study was not required for the subject or predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for permeation by chemotherapy drugs:
| Tested Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine - 3.3 mg/ml | 45.4 |
| Cisplatin - 1.0 mg/ml | >240 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Dacarbazine - 10.0 mg/ml | >240 |
| Doxorubicin HCl - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | 23.5 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
March 10, 2022
Ansell Healthcare Products LLC Donald Cronk Associate Director 2301 Robb Drive Reno, Nevada 89523
Re: K212148
Trade/Device Name: Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) 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 Dated: February 28, 2022 Received: March 1, 2022
Dear Donald Cronk:
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
1
encies. You must comply with all the Act's
Page 2
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 medical devices and radiation-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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K212148
Device Name
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have extremely low permeation times: 45.4 minutes and Thiotepa: 23.5 minutes. Warning: Do not use with Carmustine or Thiotepa.
| Tested Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine - 3.3 mg/ml | 45.4 |
| Cisplatin - 1.0 mg/ml | >240 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Dacarbazine - 10.0 mg/ml | >240 |
| Doxorubicin HCl - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | 23.5 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |
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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3
510K Summary
510(k) Number: K212148
Submitter:
Ansell Healthcare Products LLC. 2301 Robb Drive Reno, NV 89523
Contact Person(s):
Don Cronk Associate Director, Regulatory Affairs Phone: (775) 470-7106 Email: don.cronk@ansell.com
Jacob Ramirez Senior Coordinator, Regulatory Affairs Phone: (775) 624-8118 Email: jacob.ramirez@ansell.com
Date Prepared:
2/23/2022
Name of the Device:
| Trade Names: | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue)
Tested for Use with Chemotherapy Drugs | |
|----------------------------|------------------------------------------------------------------------------------------------------------|--|
| Common Name: | Patient Examination Glove | |
| Classification Name: | Patient Examination Glove | |
| Classification Regulation: | 21 CFR 880.6250 | |
| Device Class: | I | |
| Product Code: | LZA, LZC | |
| Classification Panel: | Non-powdered patient examination glove | |
Legally Marketed Predicate Device:
| Company: | Ansell Healthcare Products LLC |
|---|---|
| Trade Names: | Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for |
| Use with Chemotherapy Drugs and Fentanyl Citrate | |
| 510(k) Number: | K210401 |
| Device Class: | Class I |
| Product Code: | LZA, LZC, QDO |
| Device Name: | Patient Examination Glove (21 CFR 880.6250) |
4
Device Description:
Microflex 73-743 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs is a non-sterile, single use only, disposable, powder free examination gloves.
Characteristics:
- . Ambidextrous with beaded cuff and straight fingers
- Finger-textured .
- . Blue colored
- Five (5) sizes – extra-small, small, medium, large, and extra-large
- . Tested against chemotherapy drugs
High levels of ozone will degrade rubber material of the glove; therefore, the glove should be protected from ozone in particular.
The glove is designed to meet the specifications of ASTM D6977-19, Standard Specification for Polychloroprene Examination Gloves for Medical Application.
Indications for Use Statement:
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have extremely low permeation times: Carmustine: 45.4 minutes and Thiotepa: 23.5 minutes. Warning: Do not use with Carmustine or Thiotepa.
| TEST CHEMOTHERAPY DRUG AND
CONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTION
TIME
(Sample 1,2,3) (Minutes) |
|---------------------------------------------|----------------------------------------------------------------------------|
| Carmustine (3.3 mg/ml) | 45.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 23.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Tested chemotherapy drugs are as follows:
5
Technological Characteristics:
| Predicate | Subject Device | Comparison | ||
|---|---|---|---|---|
| Trade name | Microflex® Nitrile Patient | |||
| Examination Gloves Blue Colored | ||||
| Tested for Use with Chemotherapy | ||||
| Drugs and Fentanyl Citrate | Non-Sterile Powder-Free | |||
| Polychloroprene Examination | ||||
| Glove (Blue) Tested for Use with | ||||
| Chemotherapy Drugs | Different | |||
| Product Owner | Ansell Healthcare | Ansell Healthcare | Same | |
| Product Code | LZA, LZC, QDO | LZA, LZC | Different | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |
| Regulatory Class | I | I | Same | |
| Regulation Name | Patient Examination Glove | Patient Examination Glove | Same | |
| Indications for use | A powder-free patient | |||
| examination glove is a disposable | ||||
| device intended for medical | ||||
| purposes that is worn on the | ||||
| examiner's hand to prevent | ||||
| contamination between patient | ||||
| and examiner | A powder-free patient | |||
| examination glove is a disposable | ||||
| device intended for medical | ||||
| purposes that is worn on the | ||||
| examiner's hand to prevent | ||||
| contamination between patient | ||||
| and examiner | Same | |||
| Material | ||||
| Composition | Synthetic nitrile rubber | Polychloroprene | Different | |
| Coating | Polyacrylic polymer inner coating | |||
| to aid donning | Polyacrylic polymer inner coating | |||
| to aid donning | Same | |||
| Design | Non-sterile | Non-sterile | Same | |
| Single use | Single use | Same | ||
| Powder-free | Powder-free | Same | ||
| Ambidextrous | Ambidextrous | Same | ||
| Beaded cuff | Beaded cuff | Same | ||
| Color | Blue, Green, and Black | Blue | Different | |
| Performance | ||||
| a. Dimensions | Meets ASTM D6319-10 requirements | Meets ASTM D6977-19 requirements | Similar | |
| b. Physical Properties | Meets ASTM D6319-10 requirements | Meets ASTM D6977-19 requirements | Similar | |
| c. Freedom from holes | Meets ASTM D6319-10 requirements of GI, AQL 2.5 | Meets ASTM D6977-19 requirements of GI, AQL 2.5 | Similar | |
| d. Powder Residual | Meets ASTM D6319-10 requirements; Not more than 2.0mg/glove | Meets ASTM D6977-19 requirements; Not more than 2.0mg/glove | Similar | |
| e. Sterility | Non-sterile | Non-sterile | Same | |
| Ozone | Avoid Ozone | Avoid Ozone | Same | |
| Biocompatibility | Passes Primary Skin Irritation Test and Dermal Sensitization Test and Acute Systemic Toxicity Test and In Vitro Cytotoxicity Test | Passes Primary Skin Irritation Test and Dermal Sensitization Test and Acute Systemic Toxicity Test and In Vitro Cytotoxicity Test | Same | |
| Chemotherapy Claim | Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 47.9 minutes. Warning; Do not use with Carmustine.
Tested chemotherapy drugs/concentration & Average Minimum Breakthrough Detection Time (Minutes) are as follows: | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have extremely low permeation times: Carmustine: 45.4 minutes and Thiotepa: 23.5 minutes. Warning; Do not use with Carmustine or Thiotepa.
Tested chemotherapy drugs/concentration & Average Minimum Breakthrough Detection Time (Minutes) are as follows: | Different | |
| | Carmustine (3.3 mg/ml) $47.9$ | Carmustine (3.3 mg/ml) $45.4$ | Different | |
| | Cyclophosphamide (20.0 mg/ml) $>240$ | Cyclophosphamide (20.0 mg/ml) $>240$ | Same | |
| | Doxorubicin HCI (2.0 mg/ml) $>240$ | Doxorubicin HCI (2.0 mg/ml) $>240$ | Same | |
| | Etoposide (20.0 mg/ml) $>240$ | Etoposide (20.0 mg/ml) $>240$ | Same | |
| Fluorouracil (50.0 mg/ml) | >240 | Fluorouracil (50.0 mg/ml) | >240 | Same |
| Methotrexate (25.0 mg/ml) | >240 | Methotrexate (25.0 mg/ml) | >240 | Same |
| Paclitaxel (6.0 mg/ml) | >240 | Paclitaxel (6.0 mg/ml) | >240 | Same |
| Thiotepa (10.0 mg/ml) | >240 | Thiotepa (10.0 mg/ml) | 23.5 | Different |
| Vincristine Sulfate (1.0 mg/ml) | >240 | Vincristine Sulfate (1.0 mg/ml) | >240 | Same |
| | | Cisplatin (3.3 mg/ml) | >240 | Different |
| | | Dacarbazine (10.0 mg/ml) | >240 | Different |
| Tested hazardous drug & Average
Minimum Breakthrough Detection Time
(Minutes) are as follows: | | | | Different |
| | Fentanyl Citrate Injection
(100 mcg/2 ml) | >240 | | |
6
7
The subject device meets the applicable requirements for patient examination gloves regarding dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D6977, ASTM D5151 and ASTM D6124.
Non-Clinical Testing:
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs has the following technological characteristics as compared to ASTM or equivalent standards:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Physical Characteristics: | |||
| Dimensions: | Standard Specification | ||
| for Polychloroprene | |||
| Examination Gloves for | |||
| Medical Application | ASTM D6977-19 | Meets ASTM D6977-19 | |
| requirements for length, width and | |||
| thickness | |||
| Length | Minimum 230mm | Minimum 240mm | |
| Palm width (mm) | |||
| Size — XS | $70 \pm 10$ | $75 \pm 5$ | |
| Size — S | $80 \pm 10$ | $85 \pm 5$ |
8
| Size - M | $95 \pm 10$ | $95 \pm 5$ | |
|---|---|---|---|
| Size - L | $110\pm 10$ | $105 \pm 5$ | |
| Size - XL | $120 \pm 10$ | $115 \pm 5$ | |
| Thickness (mm) - single-wall | |||
| Finger | minimum 0.05 | Finger - min 0.09 | |
| Palm | minimum 0.05 | Palm - min 0.06 | |
| Cuff | - | Cuff - min 0.05 | |
| Physical Properties: | Standard Specification | ||
| for Polychloroprene | |||
| Examination Gloves for | |||
| Medical Application | Meets ASTM D6977-19 | ||
| requirements for tensile strength | |||
| and ultimate elongation before and | |||
| after accelerated aging: | |||
| Tensile Strength | |||
| Before Aging | minimum 14 MPa | minimum 16 MPa | |
| After Aging | minimum 14 MPa | minimum 14 MPa | |
| Ultimate Elongation | |||
| Before Aging | minimum 500% | minimum 500% | |
| After Aging | minimum 400% | minimum 400% | |
| Freedom from holes | Standard Test Method | ||
| for Detection of Holes | |||
| in Medical Gloves | ASTM D6977-19 | ||
| ASTM D5151-06 | Meets or exceeds ASTM D6977-19 | ||
| and ASTM D5151-06 requirements | |||
| of AQL 2.5 | |||
| Powder Residual | Standard Test Method | ||
| for Residual Powder on | |||
| Medical Gloves | ASTM D6977-19 | ||
| ASTM D6124-06 | Meets applicable requirement for | ||
| powder free; ≤ 2 mg per glove | |||
| Biocompatibility: | |||
| ISO Skin Irritation | |||
| Study | Biological Evaluation of | ||
| Medical Devices – Part | |||
| 10: Tests for Irritation | |||
| and Skin Sensitization | ISO10993-10:2010 | Under the conditions of the study, | |
| not an irritant | |||
| ISO Maximization | |||
| Sensitization Study | Biological Evaluation of | ||
| Medical Devices – Part | |||
| 10: Tests for Irritation | |||
| and Skin Sensitization | ISO 10993-10:2010 | Under the conditions of the study, | |
| not a sensitizer | |||
| ISO Acute Systemic | |||
| Toxicity | Biological Evaluation of | ||
| Medical Devices – Part | |||
| 11: Tests for Systemic | |||
| Toxicity | ISO 10993-11: 2006 | Under the conditions of the study, | |
| no evidence of systemic toxicity | |||
| ISO In Vitro | |||
| Cytotoxicity | Biological Evaluation of | ||
| Medical Devices – Part | |||
| 5: Tests for In Vitro | |||
| Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study | |
| undiluted, 1:2, and 1:4 dilutions | |||
| were cytotoxic (grade 4). Dilutions | |||
| of 1:8 (grade 2), 1:16 (grade 1), | |||
| 1:32 and 1:64 (grade 0) were non- | |||
| cytotoxic |
9
The subject device passes biological reactivity testing for skin irritation, dermal sensitization, acute systemic toxicity, and in vitro cytotoxicity; in accordance with the ISO 10993 series of standards.
A clinical study was not required for the subject or predicate device.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.