(103 days)
Not Found
No
The summary describes a surgical glove and its performance against chemotherapy drugs, with no mention of AI or ML technology.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical glove used for protection, not for treatment.
No
The device is a surgical glove, which is a protective barrier, not a tool used to diagnose medical conditions.
No
The device description clearly states it is a "disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect the surgical wound from contamination and for protection against chemotherapy drugs. This is a barrier function, not a diagnostic function.
- Device Description: The device is a surgical glove. Surgical gloves are considered medical devices, but not IVDs.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility. The testing performed is on the glove itself to assess its barrier properties against chemotherapy drugs.
- Performance Studies: The performance studies focus on the physical properties of the glove (holes, powder, permeation resistance) and biocompatibility, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
- Predicate Device: The predicate device is also a surgical glove, further supporting that this device falls under the category of surgical gloves, not IVDs.
In summary, this device is a medical device designed for protection and barrier function, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
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.
Product codes
KGO, LZC
Device Description
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene 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
operating room personnel
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
Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device with the following standards as shown below.
- ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
- 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
- ASTM F1929 -15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ISO 10993-5 In Vitro Cytotoxicity
- ISO 10993-10 Primary Skin Irritation
- ISO 10993-10 Dermal Sensitization
- ISO 10993-11 Acute Systemic Toxicity
- USP Pyrogen Test (USP Rabbit Test)
- USP Bacterial Endotoxins Test
Key Results:
- Chemotherapy Drug Permeation (ASTM D6978-05 (Reapproved 2019)):
- Carmustine (3.3 mg/ml): 12.3 minutes
- Cisplatin (1.0 mg/ml): >240 minutes
- Cyclophosphamide (20.0 mg/ml): >240 minutes
- Dacarbazine (10.0 mg/ml): >240 minutes
- Doxorubicin Hydrochloride (2.0 mg/ml): >240 minutes
- Etoposide (20.0 mg/ml): >240 minutes
- Fluorouracil (50.0 mg/ml): >240 minutes
- Methotrexate (25.0 mg/ml): >240 minutes
- Mitomycin C (0.5 mg/ml): >240 minutes
- Paclitaxel (6.0 mg/ml): >240 minutes
- Thiotepa (10.0 mg/ml): 17.4 minutes
- Vincristine Sulfate (1.0 mg/ml): >240 minutes
- Warning: Do not use with Carmustine and Thiotepa due to extremely low permeation times.
- Freedom from holes (ASTM D3577-19, ASTM D5151-19): Meets AQL 1.5.
- Dimensions (ASTM D3577-19): Meets requirements for length and width.
- Thickness (ASTM D3577-19): Meets requirements for palm, finger, and cuff thickness.
- Physical Properties (ASTM D3577-19): Meets requirements for tensile strength and elongation at break before and after accelerated aging.
- Powder residual (ASTM D6124-06 (2017), ASTM D3577-19): Meets requirements for Powder Free; ): Non-pyrogenic.
- Bacterial Endotoxins Test (USP ): Not Found.
Key Metrics
Not Found - The document lists breakthrough detection times for chemotherapy drugs but does not present sensitivity, specificity, PPV, NPV or AUC.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2022
Hartalega NGC SDN BHD Nurul Kong Deputy General Manager - Quality Assurance NO. 1 Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, Selangor Darul Ehsan 43900 Malaysia
Re: K221718
Trade/Device Name: Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: August 15, 2022 Received: August 23, 2022
Dear Nurul 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Oian.M.D.,Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221718
Device Name
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
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.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
× 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
510(k) SUMMARY (K221718)
FOR
POLYISOPRENE POWDER FREE SURGICAL GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
APPLICANT INFORMATION
| Date Prepared | : April 27, 2022 |
|---|---|
| Name | : Hartalega NGC Sdn. Bhd. |
| Address | : No. 1, Persiaran Tanjung, |
| Kawasan Perindustrian Tanjung, | |
| 43900 Sepang, Selangor, | |
| Malaysia | |
| Establishment Registration Number | : 3011200663 |
CORRESPONDENT AND/OR PREPARER INFORMATION
| Contact Name | : | Nurul Aisyah Kong |
|---|---|---|
| Contact Title | : | Deputy 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 | : | Surgeon's Glove |
|---|---|---|
| Trade Name (Proprietary Name) | : | Polyisoprene Powder Free Surgical Glove Tested for Use with |
| Chemotherapy Drugs | ||
| Device Class | : | 1 |
| Product Code | : | KGO, LZC |
| Regulation Number | : | 21 CFR 878.4460 |
| Reason for 510(k) Submission | : | New device |
4
PREDICATE DEVICE INFORMATION
| 510(k) Number | Tradename | Product Code |
|---|---|---|
| K190018 | Gammex Non-Latex Polyisoprene White Surgical Gloves Tested for | |
| Use with Chemotherapy Drugs | KGO |
DESCRIPTION OF THE DEVICE:
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.
INDICATIONS FOR USE:
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
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.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
5
TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| Characteristics
and
Parameters | Subject Device | Predicate Device
(K190018) | Discussion | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs | Gammex Non-Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs | Different | | |
| Applicant | Hartalega NGC Sdn. Bhd. | Ansell Healthcare Products LLC | Different | | |
| Product Code | KGO, LZC | KGO | Similar | | |
| Classification | 1 | 1 | Similar | | |
| Regulation
Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Similar | | |
| Regulation
Name | Surgeon's Glove | Surgeon's Glove | Similar | | |
| Indications for
Use | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
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. | Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Similar | | |
| | Chemotherapy
Drug and
Concentration | Minimum
Breakthrough
Detection Time in
Minutes | Chemotherapy
Drug and
Concentration | Minimum
Breakthrough
Detection Time in
Minutes | |
| | Carmustine
(3.3 mg/ml) | 12.3 | Carmustine
(3.3 mg/ml) | 10.2 | Performance
level for
Carmustine and
Thiotepa
between subject
device and
predicate device
is comparable.
Additional
Chemotherapy
drugs were
tested on the
predicate
device. |
| | Cisplatin
(1.0 mg/ml) | > 240 | Cisplatin
(1.0 mg/ml) | > 240 | |
| | Cyclophosphamide
(20.0 mg/ml) | > 240 | Cyclophosphamide
(20.0 mg/ml) | > 240 | |
| Test
Chemotherapy
Drugs | Dacarbazine
(10.0 mg/ml) | > 240 | Dacarbazine
(10.0 mg/ml) | > 240 | |
| | Doxorubicin
Hydrochloride
(2.0 mg/ml) | > 240 | Doxorubicin
Hydrochloride
(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 | |
| | 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 | |
| | Paclitaxel
(6.0 mg/ml) | > 240 | Paclitaxel
(6.0 mg/ml) | > 240 | |
| | Thiotepa
(10.0 mg/ml) | 17.4 | Thiotepa
(10.0 mg/ml) | 11.5 | |
6
| Characteristics
and
| Parameters | Subject Device | Predicate Device (K190018) | Discussion | ||
|---|---|---|---|---|---|
| Vincristine Sulfate | |||||
| (1.0 mg/ml) |
240
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa | Vincristine Sulfate (1.0 mg/ml) > 240
Blenoxane (15 mg/ml) > 240
Busulfan (6 mg/ml) > 240
Cytarabine (100 mg/ml) > 240
Daunorubicin (5 mg/ml) > 240
Docetaxel (10.0 mg/ml) > 240
Fludarabine (25 mg/ml) > 240
Gemcitabine (38 mg/ml) > 240
Idarubicin (1 mg/ml) > 240
Ifosfamide (50.0 mg/ml) > 240
Irinotecan (20.0 mg/ml) > 240
Mechlorethamine HCI (1.0 mg/ml) > 240
Melphalan (5 mg/ml) > 240
Mitoxantrone (2.0 mg/ml) > 240
Oxaliplatin (2.0 mg/ml) > 240
Paraplatin (10 mg/ml) > 240
Ellence (2 mg/ml) > 240
Rituximab (10 mg/ml) > 240
Please note that the following drugs have extremely low permeation times:
Carmustine (BCNU): 10.2 minutes and Thiotepa:11.5 minutes.
Warning: Do not use with Carmustine and Thiotepa | | | |
| Type of use | Over the counter use | Over the counter use | Similar | | |
| Materials | Polyisoprene | Polyisoprene | Similar | | |
| Color | Natural | White | Different | | |
| Design | • Single Use
• Sterile
• Powder-Free
• Hand Specific | • Single Use
• Sterile
• Powder-Free
• Hand Specific | Similar | | |
| Characteristics
and
Parameters | Subject Device | Predicate Device
(K190018) | Discussion | | |
| | • Beaded Cuff | • Beaded Cuff | | | |
| Sterility | Sterile | Sterile | Similar | | |
| Sterilization | Radiation
10-6 SAL | Radiation
10-6 SAL | Similar | | |
| Freedom from
holes | Meets ASTM D3577-19 requirements of
AQL 1.5 | Meets ASTM D3577-19 requirements of
AQL 1.5 | Similar | | |
| Length | Length (mm): ≥ 265 mm | Length (mm): ≥ 265 mm | Similar.
Meets ASTM
D3577-19 | | |
| Dimensions | 5.5: 70 ± 6 (mm)
6.0: 76 ± 6 (mm)
6.5: 83 ± 6 (mm)
7.0: 89 ± 6 (mm)
7.5: 95 ± 6 (mm)
8.0: 102 ± 6 (mm)
8.5: 108 ± 6 (mm)
9.0: 114 ± 6 (mm) | 5.5: 70 ± 6 (mm)
6.0: 76 ± 6 (mm)
6.5: 83 ± 6 (mm)
7.0: 89 ± 6 (mm)
7.5: 95 ± 6 (mm)
8.0: 102 ± 6 (mm)
8.5: 108 ± 6 (mm)
9.0: 114 ± 6 (mm) | Similar.
Meets ASTM
D3577-19 | | |
| Thickness | Cuff Thickness: ≥ 0.10 mm
Palm Thickness: ≥ 0.10 mm
Finger Thickness: ≥ 0.10 mm | Cuff Thickness: ≥ 0.10 mm
Palm Thickness: ≥ 0.10 mm
Finger Thickness: ≥ 0.10 mm | Similar.
Meets ASTM
D3577-19 | | |
| Physical
Properties | Tensile Strength Before Aging: ≥ 17 MPa
Tensile Strength After Aging: ≥ 12 MPa
Ultimate Elongation Before Aging: ≥ 650 %
Ultimate Elongation After Aging: ≥ 490 % | Tensile Strength Before Aging: ≥ 17 MPa
Tensile Strength After Aging: ≥ 12 MPa
Ultimate Elongation Before Aging: ≥ 650 %
Ultimate Elongation After Aging: ≥ 490 % | Similar.
Meets ASTM
D3577-19 | | |
| Powder residual | Residual Powder: ≤ 2 mg per glove | Residual Powder: ≤ 2 mg per glove | Similar.
Meets ASTM
D3577-19 | | |
| In Vitro
Cytotoxicity
ISO 10993-5 | Under the conditions of the study, the device
was found to be cytotoxic | Under the conditions of the study, the device
was found to be cytotoxic | Similar | | |
| Primary Skin
Irritation
ISO 10993-10 | Under the conditions of the study, the device
is not an irritant | Under the conditions of the study, the device
not an irritant | Similar | | |
| 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
not a sensitizer | Similar | | |
| Acute Systemic
Toxicity
ISO 10993-11 | Under the conditions of the study, there
was no evidence of systemic toxicity | Under the conditions of the study, there
was no evidence of systemic toxicity | Similar | | |
| Pyrogenicity
Test
USP | Under the conditions of the study, the test
article was non-pyrogenic | N/A | Additional
Pyrogenicity
Test was tested
on the subject
device | | |
| Test Methodology/
Standards | Acceptance Criteria of the
Standards | | Result Summary | | |
| | Size | Length
(mm) | Width
(mm) | | |
| Dimensions
ASTM D3577-19
Standard Specification for
Rubber Surgical Gloves | 5.5 | Min 245 | 70 ± 6 | Meets ASTM D3577-19 requirements for length
and width. Similar to predicate device. | |
| | 6.0 | Min 265 | 76 ± 6 | | |
| | 6.5 | Min 265 | 83 ± 6 | | |
| | 7.0 | Min 265 | 89 ± 6 | | |
| | 7.5 | Min 265 | 95 ± 6 | | |
| | 8.0 | Min 265 | 102 ± 6 | | |
| | 8.5 | Min 265 | 108 ± 6 | | |
| | 9.0 | Min 265 | 114 ± 6 | | |
| | | Size | Average Length (mm) | | |
| | 5.5 | 285 | 74 | | |
| | 6.0 | 283 | 80 | | |
| | 6.5 | 290 | 84 | | |
| | 7.0 | 290 | 91 | | |
| | 7.5 | 292 | 98 | | |
| | 8.0 | 300 | 103 | | |
| | 8.5 | 297 | 109 | | |
| | 9.0 | 291 | 116 | | |
| | | | Meets ASTM D3577-19 requirements for thickness.
Similar to predicate device | | |
| Dimensions | Thickness (mm) | Size | Average Palm Thickness (mm) Min | Average Finger Thickness (mm) | Average Cuff Thickness (mm) |
| ASTM D3577-19
Standard Specification for
Rubber Surgical Gloves | Palm Minimum 0.10
Finger Minimum 0.10
Cuff Minimum 0.10 | 5.5 | 0.21 | 0.23 | 0.15 |
| | | 6.0 | 0.20 | 0.23 | 0.16 |
| | | 6.5 | 0.20 | 0.23 | 0.16 |
| | | 7.0 | 0.19 | 0.23 | 0.15 |
| | | 7.5 | 0.20 | 0.24 | 0.15 |
| | | 8.0 | 0.19 | 0.23 | 0.15 |
| | | 8.5 | 0.20 | 0.24 | 0.16 |
| | | 9.0 | 0.20 | 0.24 | 0.15 |
| Physical Properties
ASTM D3577-19
Standard Specification for
Rubber Surgical Gloves | Parameter | Before Aging | After Aging | Meets ASTM D3577-19 requirements for tensile strength and elongation at break before and after accelerated aging. Similar to predicate device. | |
| | Tensile Strength | Min 17 MPa | Min 12 MPa | Before Age
Tensile Strength (MPa)
Average 17.9
Elongation at Break (%)
Average 952
Stress at 500% Elongation (MPa)
Average 2.2 | |
| | Ultimate Elongation | Min 650% | Min 490% | After Age
Tensile Strength (MPa)
Average 15.2
Elongation at Break (%)
Average 940 | |
| | Stress at 500% Elongation | Max 7.0 MPa | N/A | | |
| Freedom from holes
ASTM D5151-19
Standard Test Method for
Detection of Holes in
Medical Gloves
ASTM D3577-19
Standard Specification for
Rubber Surgical Gloves | AQL 1.5 | | | Meets ASTM D3577-19 and ASTM D5151-19 requirements of AQL 1.5. Similar to predicate device. | |
| Powder residual
ASTM D6124-06(2017)
Standard Test Method for
Residual Powder on
Medical Gloves
ASTM D3577-19
Standard Specification for
Rubber Surgical Gloves | Powder Free; ≤ 2 mg per glove | | | Meets ASTM D3577-19 and ASTM D6124-06 (2017) requirements for Powder Free; ≤ 2 mg per glove. Similar to predicate device.
Average 0.34 mg/glove | |
| Chemotherapy Drugs
Permeation
ASTM D6978-05(2019)
Standard Practice for
Assessment of Resistance of
Medical Gloves to
Permeation by
Chemotherapy Drugs | Under the conditions of the study, no permeation. | | | See results in the Table above. | |
7
8
SUMMARY OF NON-CLINICAL TESTING:
Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device with the following standards as shown below.
- . ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
- . 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
- . ASTM F1929 -15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- . ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ISO 10993-5 In Vitro Cytotoxicity .
- . ISO 10993-10 Primary Skin Irritation
- ISO 10993-10 Dermal Sensitization
- . ISO 10993-11 Acute Systemic Toxicity
- . USP Pyrogen Test (USP Rabbit Test)
- . USP Bacterial Endotoxins Test
Physical Characteristics
9
10
| Pyrogenicity Test
USP | Under the conditions of the study, the
test article was non-pyrogenic | Under the conditions of the study, the test article was
non-pyrogenic |
| -------------------------------- | -------------------------------------------------------------------------- | -------------------------------------------------------------------------- |
|---|
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 was
found to be cytotoxic and therefore the device
were evaluated under ISO 10993-11 – Test for acute
systemic toxicity.
From Acute Systemic Toxicity test, none of the test
articles were observed with signs of toxicity. Similar
to predicate device |
| Primary Skin Irritation
ISO 10993-10:2010
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. Similar to predicate device |
| 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. Similar to predicate device |
| 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. Similar to predicate device |
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 device.
CONCLUSION:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.