(184 days)
Not Found
No
The device is a physical examination glove and the summary describes standard physical and chemical testing, with no mention of AI or ML.
No.
The device is an examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner and has no stated function related to diagnosis.
No
The device is a physical examination glove made from nitrile latex, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: It's described as an examination glove.
- Performance Studies: The performance studies focus on the physical properties of the glove (dimensions, strength, freedom from holes, powder residual), resistance to chemicals (chemotherapy drugs, fentanyl citrate), and biological compatibility (cytotoxicity, sensitization, irritation, systemic toxicity). These are all related to the glove's function as a barrier and its safety for the user and patient, not to diagnosing a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any of these functions.
N/A
Intended Use / Indications for Use
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (Fusion Colour) is a disposable single-use, non-sterile, fusion-colored and powder-free examination glove made from nitrile latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The device underwent non-clinical testing to demonstrate substantial equivalence. The tests performed are:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application for Dimensions, Physical Properties.
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves for Freedom from holes.
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves for Powder residual.
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs for Chemotherapy Drugs Permeation and Fentanyl Citrate.
- ISO 10993-5 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for skin sensitization.
- ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation.
- ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves for Shelf-Life Expiry.
Key results:
- Dimensions: Meets ASTM D6319-19 requirements for length, width, and thickness.
- Physical Properties: Meets ASTM D6319-19 requirements for tensile strength and elongation at break before and after accelerated aging.
- Freedom from holes: Meets ASTM D6319-19 and ASTM D5151-19 requirements of AQL 2.5 (passed at AQL 1.5).
- Powder residual: Meets ASTM D6319-19 and ASTM D6124-06 (2017) requirements for Powder Free; ≤ 2 mg per glove (Average 0.14 mg/glove).
- Chemotherapy Drugs Permeation: Passed permeability tests for most chemotherapy drugs (> 240 minutes breakthrough time), except Carmustine (12.1 minutes) and Thiotepa (37.8 minutes). A warning is issued not to use with Carmustine. Fentanyl Citrate also showed > 240 minutes breakthrough time.
- Biocompatibility:
- In Vitro Cytotoxicity: The neat extract was found to be cytotoxic.
- Dermal Sensitization: Not a sensitizer.
- Primary Skin Irritation: Not an irritant.
- Acute Systemic Toxicity: Showed no evidence of acute systemic toxicity.
- Shelf-Life Expiry: 3 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See individual test result summaries above.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). 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.
May 17, 2023
Hartalega NGC SDN. BHD. Nurul Aisyah Kong General Manager-Ouality Assurance No. 1. Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang. Selangor Darul Ehsan 43900 Malaysia
Re: K223437
Trade/Device Name: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: March 15, 2023 Received: March 20, 2023
Dear Nurul Aisyah Kong:
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 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.
Bifeng Qian -S
Bifeng Qian, 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
2
Indications for Use
510(k) Number (if known) K223437
Device Name
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
Indications for Use (Describe)
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| 5-Azacytidine (25.0 mg/ml) | > 240 |
| Carboplatin (10.0 mg/ml) | > 240 |
| Carmustine (3.3 mg/ml) | 12.1 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxetacel (10.0 mg/ml) | > 240 |
| Doxorubicin HCI (2.0 mg/ml) | > 240 |
| Epirubicin (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Gemcitabine (38.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Irinotecan (20.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Oxalipatin (5.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 37.8 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Oncovin (1.0 mg/ml) | > 240 |
| Vinorelbine (10.0mg/ml) | > 240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2ml) | >240 |
Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 12.1 minutes and 37.8 minutes.
Warning: Do not use with Carmustine.
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)
3
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4
510(k) SUMMARY
K223437
BIODEGRADABLE NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE (FUSION COLOUR)
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
SUBMISSION APPLICANT
| Date Prepared | : | May 15, 2023 |
|---|---|---|
| Name | : | Hartalega NGC Sdn. Bhd. |
| Address | : | No. 1, Persiaran Tanjung, |
| Kawasan Perindustrian Tanjung, | ||
| Sepang, Selangor Darul Ehsan, 43900 | ||
| Malaysia | ||
| Establishment Registration Number | : | 3011200663 |
SUBMISSION CORRESPONDENT AND/OR PREPARER
| Contact Name | : | Nurul Aisyah Kong |
|---|---|---|
| Contact Title | : | General Manager - Quality Assurance |
| Phone Number | : | (603) 3280 3888 |
| Fax Number | : | (603) 3271 0135 |
| Contact Email | : | wkkong@hartalega.com.my |
DEVICE IDENTIFICATION
| Common Name of the Device | : | Non-Powdered Patient Examination Glove |
|---|---|---|
| Trade Name (Proprietary Name) | : | Biodegradable Nitrile Powder Free Examination Glove Tested for |
| Use with Chemotherapy Drugs and Fentanyl Citrate | ||
| (Fusion Colour) | ||
| Device Class | : | 1 |
| Product Code | : | LZA, LZC, QDO, OPJ |
| Regulation Number | : | 21 CFR 880.6250 |
| Reason for 510(k) Submission | : | New device |
5
PREDICATE DEVICE INFORMATION
| 510(k) Number | Tradename | Product Code | ||
|---|---|---|---|---|
| K200581 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use | |||
| with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA. LZC, QDO | |||
| Regulation Name | : | Non-Powdered Patient Examination Glove | ||
| Trade Name (Proprietary Name) | ||||
| Biodegradable Nitrile Powder Free Examination Glove Tested for Use | ||||
| : | ||||
| with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | ||||
| Device Class | ||||
| Product Code | : | LZA, LZC, QDO, OPJ | ||
| Regulation Number | : | 21 CFR 880.6250 |
DESCRIPTION OF THE DEVICE:
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (Fusion Colour) is a disposable single-use, non-sterile, fusion-colored and powder-free examination glove made from nitrile latex.
INDICATIONS FOR USE:
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentary1 Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
6
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| 5- Azacytidine, 25.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 |
| Carmustine (3.3 mg/ml) | 12.1 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Docetaxel, 10.0 mg/ml | > 240 |
| Doxorubicin HCL (2.0 mg/ml) | > 240 |
| Epirubicin, 2.0 mg/ml | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Gemcitabine, 38.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Irinotecan, 20.0 mg/ml | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 |
| Oxaliplatin, 2.0 mg/ml | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 37.8 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Oncovin (1.0 mg/ml) | > 240 |
| Vinorelbine, 10.0 mg/ml | > 240 |
| Fentanyl Citrate, 100.0 mcg/2ml | > 240 |
Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 12.1 minutes.
Warning: Do not use with Carmustine.
7
TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| Characteristics
and Parameters | Subject Device | Predicate Device
(K200581) | Discussion |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Biodegradable Nitrile Powder Free
Examination Glove Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate
(Fusion Colour) | Biodegradable Nitrile Powder Free
Examination Glove Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate
(Blue) | - |
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega NGC Sdn. Bhd. | Same |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Similar |
| Classification | 1 | 1 | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Regulation
Name | Non-Powdered Patient Examination Glove | Non-Powdered Patient Examination Glove | Same |
| Indications for
Use | A non-sterile disposable device intended for
medical purpose that is worn on the
examiner's hand to prevent contamination
between patient and examiner. It is also tested
to be used against Chemotherapy Drugs and
Fentanyl Citrate.
The gloves were tested for use with
chemotherapy drugs as per ASTM D6978-05
(Reapproved 2019) Standard Practice for
Assessment of Resistance of Medical Gloves
to Permeation by Chemotherapy Drugs. | A non-sterile disposable device intended for
medical purpose that is worn on the examiner's
hand to prevent contamination between patient
and examiner. It is also tested to be used against
Chemotherapy Drugs and Fentanyl Citrate.
The gloves were tested for
use with
chemotherapy drugs as per ASTM D6978-05
(Reapproved 2013) Standard Practice for
Assessment of Resistance of Medical Gloves to
Permeation by Chemotherapy Drugs. | Similar |
8
| Characteristics
and Parameters | Subject Device | | Predicate Device
(K200581) | | Discussion |
|-----------------------------------|----------------------------------------|---------------------------------------------------------|------------------------------------|---------------------------------------------------------|------------|
| | Chemotherapy Drug and
Concentration | Minimum
Breakthrough
Detection Time
in Minutes | Chemotherapy Drug
Concentration | Minimum
Breakthrough
Detection Time
in Minutes | |
| Test
Chemotherapy
Drugs | 5-Azacytidine, 25.0mg/ml | > 240 | 5-Azacytidine, 25.0mg/ml | > 240 | Similar |
| | Carboplatin, 10.0 mg/ml | > 240 | Carboplatin, 10.0 mg/ml | > 240 | |
| | Carmustine (3.3 mg/ml) | 12.1 | Carmustine (3.3 mg/ml) | 21.4 | |
| | Cisplatin (1.0 mg/ml) | > 240 | Cisplatin (1.0 mg/ml) | > 240 | |
| | Cyclophosphamide (20.0 mg/ml) | > 240 | Cyclophosphamide (20.0 mg/ml) | > 240 | |
| | Dacarbazine (10.0 mg/ml) | > 240 | Dacarbazine (10.0 mg/ml) | > 240 | |
| | Docetaxel, 10.0 mg/ml | > 240 | Docetaxel, 10.0 mg/ml | > 240 | |
| | Doxorubicin HCL (2.0 mg/ml) | > 240 | Doxorubicin HCL (2.0 mg/ml) | > 240 | |
| | Epirubicin HCL, 2.0 mg/ml | > 240 | Epirubicin HCL, 2.0 mg/ml | > 240 | |
| | Etoposide (20.0 mg/ml) | > 240 | Etoposide (20.0 mg/ml) | > 240 | |
| | Fluorouracil (50.0 mg/ml) | > 240 | Fluorouracil (50.0 mg/ml) | > 240 | |
| | Gemcitabine, 38.0 mg/ml | > 240 | Gemcitabine, 38.0 mg/ml | > 240 | |
| | Ifosfamide, 50.0 mg/ml | > 240 | Ifosfamide, 50.0 mg/ml | > 240 | |
| | Irinotecan, 20.0 mg/ml | > 240 | Irinotecan, 20.0 mg/ml | > 240 | |
| | Methotrexate (25.0 mg/ml) | > 240 | Methotrexate (25.0 mg/ml) | > 240 | |
| | Methotrexate (25.0 mg/ml) | > 240 | Methotrexate (25.0 mg/ml) | > 240 | |
| | Mitomycin C (0.5 mg/ml) | > 240 | Mitomycin C (0.5 mg/ml) | > 240 | |
| | Mitoxantrone, 2.0 mg/ml | > 240 | Mitoxantrone, 2.0 mg/ml | > 240 | |
| | Oxaliplatin, 5.0 mg/ml | > 240 | Oxaliplatin, 5.0 mg/ml | > 240 | |
| | Paclitaxel (6.0 mg/ml) | > 240 | Paclitaxel (6.0 mg/ml) | > 240 | |
| | Thiotepa (10.0 mg/ml) | 37.8 | Thiotepa (10.0 mg/ml) | 67.2 | |
| | Vincristine Sulfate (1.0 mg/ml) | > 240 | Vincristine Sulfate (1.0 mg/ml) | > 240 | |
| | Oncovin (1.0 mg/ml) | > 240 | Oncovin (1.0 mg/ml) | > 240 | |
| | Vinorelbine, 10.0 mg/ml | > 240 | Vinorelbine, 10.0 mg/ml | > 240 | |
| | Fentanyl Citrate, 100.0 mcg/2ml | > 240 | Fentanyl Citrate, 100.0 mcg/2ml | > 240 | |
9
| Characteristics
and Parameters | Subject Device | Predicate Device
(K200581) | Discussion |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Color | Fusion Colour | Blue | Different |
| Design | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | Similar |
| Sterility | Non-sterile | Non-sterile | Same |
| Freedom from
holes | Meets ASTM D5151-19:
AQL 1.5 | Meets ASTM D5151-06(2015):
AQL 1.5 | Similar |
| Length | Meets ASTM D6319-19:
XS: ≥ 220 mm
S: ≥ 220 mm
M: ≥ 230 mm
L: ≥ 230 mm
XL: ≥ 230 mm | Meets ASTM D6319-10(2015):
≥ 230 mm | Similar |
| Characteristics
and Parameters | Subject Device | Predicate Device
(K200581) | Discussion |
| Width | Meets ASTM D6319-19:
XS: 60 - 80 mm
S: 70 - 90 mm
M: 85 - 105 mm
L: 100 - 120 mm
XL: 110 - 130 mm | Meets ASTM D6319-10(2015):
XS: 60 - 80 mm
S: 70 - 90 mm
M: 85 - 105 mm
L: 100 - 120 mm
XL: 110 - 130 mm | Similar |
| Thickness | Meets ASTM D6319-19:
Palm Thickness: ≥ 0.05 mm
Finger Thickness: ≥ 0.05 mm | Meets ASTM D6319-10(2015):
Palm Thickness: ≥ 0.05 mm
Finger Thickness: ≥ 0.05 mm | Similar |
| Physical
Properties | Meets ASTM D6319-19:
Tensile Strength Before Aging: ≥ 14 MPa
Tensile Strength After Aging: ≥ 14 MPa
Ultimate Elongation Before Aging: ≥ 500 %
Ultimate Elongation After Aging: ≥ 400 % | Meets ASTM D6319-10(2015):
Tensile Strength Before Aging: ≥ 14 MPa
Tensile Strength After Aging: ≥ 14 MPa
Ultimate Elongation Before Aging: ≥ 500 %
Ultimate Elongation After Aging: ≥ 400 % | Similar |
| Powder residual | Meets ASTM D6124-06 (2017):
Residual Powder: ≤ 2 mg per glove | Meets ASTM D6124-06 (2017):
Residual Powder: ≤ 2 mg per glove | Similar |
| In vitro
Cytotoxicity
ISO 10993-5 | The neat extract was found to be cytotoxic | NA | Different |
| Dermal
Sensitization
ISO 10993-10 | Under the conditions of the study, the
device is not a sensitizer | Under the conditions of the study, the device is
not a sensitizer | Similar |
| Characteristics
and Parameters | Subject Device | Predicate Device
(K200581) | Discussion |
| Acute Systemic
Toxicity Test
ISO 10993-11 | Under the conditions of this study, the
device showed no evidence of acute
systemic toxicity | Under the conditions of this study, the device
showed no evidence of acute systemic toxicity | Similar |
| Primary Skin
Irritation
ISO 10993-23 | Under the conditions of the study, the
device is not an irritant | Under the conditions of the study, the device is
not an irritant | Similar |
| Shelf-Life Expiry
ASTM D7160-16 | 3 years | 3 years | Identical |
10
11
12
SUMMARY OF NON-CLINICAL TESTING:
Provided are the test methodology used to demonstrate whether the acceptance criteria in each respective standard.
- . Biodegradability is not a medical claim and therefore was not reviewed by FDA.
- . 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
- . ISO 10993-5 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for skin sensitization .
- . ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
- . ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
Physical Characteristics
| Test Methodology/
Standards | Acceptance Criteria of the
Standards | Result Summary | | | | | | | | | |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------------------------|------------------------------|--------------------------------------------------------------------------------------------------|------------------------|--------------------------------------|----------------------------------------|--|----|------|------|
| Dimensions
ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves for
Medical Application | Size
XS | Length
(mm)
Min 220 | Width
(mm)
70 ± 10 | Meets ASTM D6319-19 requirements for length, and width. Similar to predicate device.
Size | Average
Length (mm) | Average
Width (mm) | | | | | |
| | S | Min 220 | 80 ± 10 | | | | | | | | |
| | M | Min 230 | 95 ± 10 | | | | | | | | |
| | L | Min 230 | 110 ± 10 | | | | | | | | |
| | XL | Min 230 | 120 ± 10 | | | | | | | | |
| | XS | | | | 240 | 76 | | | | | |
| | S | | | | 242 | 86 | | | | | |
| | M | | | | 239 | 97 | | | | | |
| | L | | | | 246 | 107 | | | | | |
| | XL | | | | 245 | 114 | | | | | |
| Dimensions
ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves for
Medical Application | Thickness (mm)
Palm
Finger | | Minimum 0.05
Minimum 0.05 | Meets ASTM D6319-19 requirements for thickness.
Similar to predicate device | Size | Average
Palm
Thickness
(mm) | Average
Finger
Thickness
(mm) | | | | |
| | | | | | | | | | XS | 0.05 | 0.08 |
| | | | | | | | | | S | 0.05 | 0.08 |
| | | | | | | | | | M | 0.06 | 0.08 |
| | | | | | | | | | L | 0.06 | 0.08 |
| | | | | XL | 0.06 | 0.08 | | | | | |
13
| Physical Properties
ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves
for Medical Application | Parameter | Before
Aging | After
Aging | Meets ASTM D6319-19 requirements for tensile
strength and elongation at break before and after
accelerated aging. Similar to predicate device.
Before Age
Tensile Strength (MPa)
Average 35
Elongation at Break (%)
Average 565
After Age
Tensile Strength (MPa)
Average 36
Elongation at Break (%)
Average 469 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tensile
Strength | Min
14 MPa | Min
14 MPa | |
| | Ultimate
Elongation | Min
500% | Min
400% | |
| Freedom from holes
ASTM D5151-19
Standard Test Method for
Detection of Holes in Medical
Gloves
ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves
for Medical Application | AQL 2.5 | | | Meets ASTM D6319-19 and ASTM D5151-19
requirements of AQL 2.5. Similar to predicate
device.
Inspection Level G1
AQL Level 1.5
Although pass at AQL 1.5 quality level, it complies
with ASTM D6319-19 and ASTM D5151-19.
requirements of AQL 2.5 |
| Powder residual
ASTM D6124-06(2017)
Standard Test Method for
Residual Powder on Medical
Gloves
ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves for
Medical Application | Powder Free; ≤ 2 mg per glove | | | Meets ASTM D6319-19 and ASTM D6124-06
(2017) requirements for Powder Free; ≤ 2 mg per
glove. Similar to predicate device.
Average 0.14 mg/glove |
14
| Chemotherapy Drugs
Permeation | | Chemotherapy Drug and
Concentration | Minimum
Breakthrough
Detection Time
in Minutes |
|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| ASTM D6978-05(2019)
Standard Practice for
Assessment of Resistance of
Medical Gloves to
Permeation by
Chemotherapy Drugs | Under the conditions of the study, the
permeation is acceptable. | 5- Azacytidine, 25.0 mg/ml | > 240 |
| | | Carboplatin, 10.0 mg/ml | > 240 |
| | | Carmustine (3.3 mg/ml) | 12.1 |
| | | Cisplatin (1.0 mg/ml) | > 240 |
| | | Cyclophosphamide (20.0 mg/ml) | > 240 |
| | | Dacarbazine (10.0 mg/ml) | > 240 |
| | | Docetaxel, 10.0 mg/ml | > 240 |
| | | Doxorubicin HCL (2.0 mg/ml) | > 240 |
| | | Epirubicin HCL, 2.0 mg/ml | > 240 |
| | | Etoposide (20.0 mg/ml) | > 240 |
| | | Fluorouracil (50.0 mg/ml) | > 240 |
| | | Gemcitabine, 38.0 mg/ml | > 240 |
| | | Ifosfamide, 50.0 mg/ml | > 240 |
| | | Irinotecan, 20.0 mg/ml | > 240 |
| | | Methotrexate (25.0 mg/ml) | > 240 |
| | | Mitomycin C (0.5 mg/ml) | > 240 |
| | | Mitoxantrone, 2.0 mg/ml | > 240 |
| | | Oxaliplatin, 5.0 mg/ml | > 240 |
| | | Paclitaxel (6.0 mg/ml) | > 240 |
| | | Thiotepa (10.0 mg/ml) | 37.8 |
| | | Vincristine Sulfate (1.0 mg/ml) | > 240 |
| | | Oncovin (1.0 mg/ml) | > 240 |
| | | Vinorelbine, 10.0 mg/ml | > 240 |
| | | Fentanyl Citrate, 100.0 mcg/2ml | > 240 |
| | | Under the conditions of the study, the permeation is
acceptable. Similar to predicate devices.
Performance level of drugs between subject device
and predicate devices are comparable | |
Biocompatibility
| Test Methodology/
Standards | Acceptance Criteria of the
Standards | Result Summary |
|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------|
| In Vitro Cytotoxicity
ISO 10993-5:2009
Biological evaluation of
medical devices - Part 5:
Tests for in vitro
cytotoxicity | Under the conditions of the study, the
device is not cytotoxic | Under the conditions of the study, the device to be
found have cytotoxic effect |
| Dermal Sensitization
ISO 10993-10:2021
Biological evaluation of
medical devices - Part 10:
Tests for skin sensitization | Under the conditions of the study, the
device is not a sensitizer | Under the conditions of the study, the device is not
a sensitizer. |
15
| Primary Skin Irritation
ISO 10993-23:2021
Biological evaluation of
medical devices — Part 10:
Tests for irritation and skin
sensitization | Under the conditions of the study, the
device is not an irritant | Under the conditions of the study, the device is not
an irritant. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Acute Systemic Toxicity
ISO 10993-11:2017
Biological evaluation of
medical devices —
Part 11: Tests for systemic
toxicity | Under the conditions of the study, the
device does not pose a toxicity
concern | Under the conditions of the study, there was no signs
of toxicity. |
CLINICAL PERFORMANCE DATA:
Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate devices.
CONCLUSION:
The conclusion drawn from the non-clinical tests demonstrates that the subject device herein mentioned is as safe, effective, and performs as well as or better than the legally marketed predicate device (K200581).